# bib

id: cord-348306-e8hdx4u2
author: Li, Jie
date: 2020-07-24
extension: .txt
mime: text/plain
words: 658
sentence: 22
flesch: 33
cache: cache/cord-348306-e8hdx4u2.txt
txt: txt/cord-348306-e8hdx4u2.txt
title:
  Meta-trial of awake prone positioning with nasal high flow therapy: Invitation to join a pandemic collaborative research effort

summary:
  Adherence to methodological standards of individual trials represents a guarantee of a high level of overall final quality. Awake.Prone.Meta.Trial@gmail.com J o u r n a l P r e -p r o o f Intensive care management of coronarvirus disease 2019 (COVID-19): Challenges and Recommendations Patient eligibility for randomized controlled trials in critical care medicine: an international two-center observational study Prone position for acute respiratory distress syndrome.


id: cord-280020-nrnc8u28
author: Zhao, Yang
title: Appealing for Efficient, Well Organized Clinical Trials on COVID-19
date: 2020-03-07
extension: .txt
mime: text/plain
words: 911
sentence: 46
flesch: 44
cache: cache/cord-280020-nrnc8u28.txt
txt: txt/cord-280020-nrnc8u28.txt
summary:
  key: cord-280020-nrnc8u28 authors: Zhao, Yang; Wei, Yongyue; Shen, Sipeng; Zhang, Mingzhi; Chen, Feng title: Appealing for Efficient, Well Organized Clinical Trials on COVID-19 date: 2020-03-07 journal: nan DOI: 10.1101/2020.03.05.20031476 sha: doc_id: 280020 cord_uid: nrnc8u28 The rapid emergence of clinical trials on COVID-19 stimulated a wave of discussion in scientific community. Clinical trials on COVID-19 should be designed based on scientific rules, ethics and benefits for patients.


id: cord-345095-1li57v0j
author: Felix, Carol
title: Clinical Research in the Time of COVID-19
date: 2020-10-01
extension: .txt
mime: text/plain
words: 1244
sentence: 59
flesch: 52
cache: cache/cord-345095-1li57v0j.txt
txt: txt/cord-345095-1li57v0j.txt
summary:
  The need for clinical trials, the improved treatments they elucidate, and the US Food and Drug Administration (FDA) approval providing public access to these new and better treatments will remain. The pandemic does not end medical research, and it may, in fact, point us in a new and better direction for implementing clinical trials.


id: cord-322534-eikz07zz
author: Allahyari, Abolghasem
date: 2020-06-26
extension: .txt
mime: text/plain
words: 1251
sentence: 67
flesch: 49
cache: cache/cord-322534-eikz07zz.txt
txt: txt/cord-322534-eikz07zz.txt
title:
  Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial

summary:
  Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study. key: cord-322534-eikz07zz authors: Allahyari, Abolghasem; Rahimi, Hossein; Khadem-Rezaiyan, Majid; Mozaheb, Zahra; Seddigh-Shamsi, Mohsen; Bary, Alireza; Kamandi, Mostafa; Azimi, Sajad Ataei; HasanAbadi, Saeed Eslami; Noferesti, Alireza; Shariatmaghani, Somayeh Sadat; Rafatpanah, Houshang; Khatami, Shohreh; Imani, Afshin Jabbar; Mortazi, Hassan; Nodeh, Mohammad Moeini title: Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial date: 2020-06-26 journal: Trials DOI: 10.1186/s13063-020-04485-x sha: doc_id: 322534 cord_uid: eikz07zz OBJECTIVES:


id: cord-276092-4e4muqnu
author: Dal-Re, Rafael
title: Waste in COVID-19 clinical trials conducted in western Europe
date: 2020-07-07
extension: .txt
mime: text/plain
words: 1277
sentence: 49
flesch: 47
cache: cache/cord-276092-4e4muqnu.txt
txt: txt/cord-276092-4e4muqnu.txt
summary:
  So as not to waste the generosity from trial participants and the effort from investigators of all these trials, de-identified individual participant clinical trial data should be forwarded to two teams that are conducting living systematic reviews with network meta-analysis [9,10], that could report their results in a short period of time. On the searches on ClinicalTrials.gov, the following descriptors were also used: Study type: 'Interventional studies (clinical trials)'; Status: recruitments: 'Not yet recruiting', 'recruiting' and 'active: not recruiting'; Funder type: 'NIH', 'Other US Federal Agency' and 'All others (individuals, universities, organizations)'.


id: cord-026998-vlmoa5dr
author: McCulloch, Peter
title: COVID-19 has no effect on gravity
date: 2020-06-03
extension: .txt
mime: text/plain
words: 1196
sentence: 53
flesch: 57
cache: cache/cord-026998-vlmoa5dr.txt
txt: txt/cord-026998-vlmoa5dr.txt
summary:
  Governments have swept aside sedate procedures which normally add months or years to the life cycle of research projects, and offered huge sums to speed any projects which offer hope of a solution. Of course medical research has been hugely affected, this being a medical crisis.


id: cord-316626-258rbcwb
author: Serpa Neto, Ary
title: Will Evidence-based Medicine Survive the COVID-19 Pandemic?
date: 2020-09-17
extension: .txt
mime: text/plain
words: 1459
sentence: 50
flesch: 34
cache: cache/cord-316626-258rbcwb.txt
txt: txt/cord-316626-258rbcwb.txt
summary:
  Effects of hydroxychloroquine on immune activation and disease progression among HIV-infected patients not receiving antiretroviral therapy: a randomized controlled trial Association of treatment with hydroxychloroquine or azithromycin with in-hospital mortality in patients with COVID-19 in New York state Observational study of hydroxychloroquine in hospitalized patients with Covid-19 Effect of high vs low doses of chloroquine diphosphate as adjunctive therapy for patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: a randomized clinical trial Arguing for adaptive clinical trials in sepsis Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop Using Bayesian adaptive designs to improve phase III trials: a respiratory care example ORCHID Protocol Committee and the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Network Investigators. One major challenge during the pandemic is to design clinical trials that can mitigate these concerns and quickly identify effective or harmful interventions to improve patient outcomes.


id: cord-031978-l6nlrv9h
author: Chauvenet, Alienor
title: Panel sampling in health research
date: 2020-09-16
extension: .txt
mime: text/plain
words: 1435
sentence: 62
flesch: 39
cache: cache/cord-031978-l6nlrv9h.txt
txt: txt/cord-031978-l6nlrv9h.txt
summary:
  First, to reach a sufficient number of participants in randomised clinical trials, international consortia should be established to enable recruitment within a reasonable timeframe. A target protocol describes the ideal, but unachievable randomised clinical trial.


id: cord-327738-i400ynjp
author: Milner, Ross
date: 2020-04-27
extension: .txt
mime: text/plain
words: 1754
sentence: 63
flesch: 32
cache: cache/cord-327738-i400ynjp.txt
txt: txt/cord-327738-i400ynjp.txt
title:
  Is it Ethically Appropriate to Continue Surgical Clinical Trials During the COVID-19 Pandemic? EDITED BY DR SARR

summary:
  We discuss here the ethics of clinical trial care within the surgical specialties and the the pros and cons of participation in clinical trial during the COVID-19 pandemic, with a specific focus on surgical oncology and vascular surgery. The status of surgical clinical trials during this pandemic has not been addressed.


id: cord-283197-jjye8t6j
author: Ingraham, Nicholas E.
date: 2020-04-29
extension: .txt
mime: text/plain
words: 1871
sentence: 84
flesch: 37
cache: cache/cord-283197-jjye8t6j.txt
txt: txt/cord-283197-jjye8t6j.txt
title:
  Fact Versus Science Fiction: Fighting Coronavirus Disease 2019 Requires the Wisdom to Know the Difference

summary:
  Widespread use and misconception of hydroxychloroquine being a cure may result in reduced enrollment in hydroxychloroquine trials or hesitation to enroll in other drug trials that are not hydroxychloroquine. This commentary uses a recent study of hydroxychloroquine to demonstrate the dire need for randomized clinical trials, but more importantly, to explore the potential consequences of misinformation, how fear fuels its impact, and offer guidance to maintain scientific integrity without relinquishing hope. Chloroquine, and its less toxic metabolite hydroxychloroquine, are chemotherapeutic agents used to treat malaria (1).


id: cord-282261-wcmc5mh6
author: Rhodus, Elizabeth K.
title: COVID-19 and geriatric clinical trials research
date: 2020-09-16
extension: .txt
mime: text/plain
words: 2258
sentence: 90
flesch: 31
cache: cache/cord-282261-wcmc5mh6.txt
txt: txt/cord-282261-wcmc5mh6.txt
summary:
  Further, older adults are substantially underrepresented in clinical trials research, and this situation may worsen this discrepancy. Attention to clinical trial development with special attention to need for inclusion of older adults and precautions is greatly needed to sustain current efforts, at minimum, and ideally, enhance recognition of the value of including older adults in clinical trial research.


id: cord-271514-sls3bsm0
author: Dean, Natalie E.
title: Ensemble Forecast Modeling for the Design of COVID-19 Vaccine Efficacy Trials
date: 2020-09-15
extension: .txt
mime: text/plain
words: 2501
sentence: 105
flesch: 36
cache: cache/cord-271514-sls3bsm0.txt
txt: txt/cord-271514-sls3bsm0.txt
summary:
  key: cord-271514-sls3bsm0 authors: Dean, Natalie E.; Pastore y Piontti, Ana; Madewell, Zachary J.; Cummings, Derek A.T; Hitchings, Matthew D.T.; Joshi, Keya; Kahn, Rebecca; Vespignani, Alessandro; Elizabeth Halloran, M.; Longini, Ira M. title: Ensemble Forecast Modeling for the Design of COVID-19 Vaccine Efficacy Trials date: 2020-09-15 journal: Vaccine DOI: 10.1016/j.vaccine.2020.09.031 sha: doc_id: 271514 cord_uid: sls3bsm0 To rapidly evaluate the safety and efficacy of COVID-19 vaccine candidates, prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration. Selecting vaccine trial sites where disease incidence is highest during the study period can accelerate the accrual of endpoints.


id: cord-286144-6wtk5y7c
author: Tini, Giulia
date: 2020-06-29
extension: .txt
mime: text/plain
words: 2339
sentence: 80
flesch: 25
cache: cache/cord-286144-6wtk5y7c.txt
txt: txt/cord-286144-6wtk5y7c.txt
title:
  Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness

summary:
  As COVID-19-devoted resources grow, quantifying the potential impact of COVID-19 trials becomes a relevant matter for global and national health policies. However, quality research on clinical trials is rendered difficult by the lack of a standardized definition of trial parameters.


id: cord-347189-i9rzo3j0
author: Lorusso, Domenica
title: Clinical research disruption in the post-COVID-19 era: will the pandemic lead to change?
date: 2020-10-13
extension: .txt
mime: text/plain
words: 3313
sentence: 116
flesch: 33
cache: cache/cord-347189-i9rzo3j0.txt
txt: txt/cord-347189-i9rzo3j0.txt
summary:
  Moreover, less than 5% of cancer clinical trials adequately accrue ethnic minorities (OR 0.7 with respect to white patients in cancer clinical trials) 10 and a potential explanation is that travel burden to centres mandated by specific trials (eg, rare cancers) implies time off from work and family commitments for both patients and careers leading to financial repercussions. The effect of telehealth interventions on quality of life of cancer patients: a systematic review and meta-analysis Participation in cancer clinical trials: race-, sex-, and age-based disparities At what cost to clinical trial enrollment?


id: cord-294651-iy0h2pyf
author: Nasrallah, Ali A.
date: 2020-06-08
extension: .txt
mime: text/plain
words: 3366
sentence: 155
flesch: 42
cache: cache/cord-294651-iy0h2pyf.txt
txt: txt/cord-294651-iy0h2pyf.txt
title:
  A large number of COVID-19 interventional clinical trials were registered soon after the pandemic onset: a descriptive analysis

summary:
  A major limitation of our study is that the pool of COVID-19 registered trials is rapidly growing, hence the data would need to be periodically updated. key: cord-294651-iy0h2pyf authors: Nasrallah, Ali A.; Farran, Sarah H.; Nasrallah, Zainab A.; Chahrour, Mohamad A.; Salhab, Hamza A.; Fares, Mohammad Y.; Khachfe, Hussein H.; Akl, Elie A. title: A large number of COVID-19 interventional clinical trials were registered soon after the pandemic onset: a descriptive analysis date: 2020-06-08 journal: J Clin Epidemiol DOI: 10.1016/j.jclinepi.2020.06.005 sha: doc_id: 294651 cord_uid: iy0h2pyf Abstract Background There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the Coronavirus disease 2019 (COVID-19) pandemic.


id: cord-266573-vfl08i2p
author: Largent, Emily A
title: Paying Participants in COVID-19 Trials
date: 2020-05-29
extension: .txt
mime: text/plain
words: 3638
sentence: 125
flesch: 30
cache: cache/cord-266573-vfl08i2p.txt
txt: txt/cord-266573-vfl08i2p.txt
summary:
  These difficult background circumstances do not make offers of payment to COVID-19 research participants impermissible. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances.


id: cord-048447-chz8luni
author: Duffett, Mark
title: Surfactant therapy for acute respiratory failure in children: a systematic review and meta-analysis
date: 2007-06-15
extension: .txt
mime: text/plain
words: 3999
sentence: 172
flesch: 33
cache: cache/cord-048447-chz8luni.txt
txt: txt/cord-048447-chz8luni.txt
summary:
  We selected search terms from the keywords and MESH terms of previous surfactant trials and from the generic and brand names of commercially available surfactants. We searched the MEDLINE, EMBASE, CINAHL and Ovid Healthstar databases, the bibliographies of included trials and review articles, conference proceedings and trial registries.


id: cord-267699-h7ftu3ax
author: MacIntyre, C. Raina
date: 2020-04-30
extension: .txt
mime: text/plain
words: 4129
sentence: 166
flesch: 44
cache: cache/cord-267699-h7ftu3ax.txt
txt: txt/cord-267699-h7ftu3ax.txt
title:
  A RAPID SYSTEMATIC REVIEW OF THE EFFICACY OF FACE MASKS AND RESPIRATORS AGAINST CORONAVIRUSES AND OTHER RESPIRATORY TRANSMISSIBLE VIRUSES FOR THE COMMUNITY, HEALTHCARE WORKERS AND SICK PATIENTS

summary:
  The five available studies of mask use by sick patients suggest a benefit, but are much smaller trials than the community trials, two without clinical endpoints, and with less certainty around the findings (34) (35) (36) (37) . They also found no evidence of efficacy of hand hygiene or health education, suggesting mask use is more protective than hand hygiene.


id: cord-279197-cesemos0
author: Block, Keith I.
title: Integrative Cancer Therapies: Learning From COVID-19
date: 2020-06-21
extension: .txt
mime: text/plain
words: 4120
sentence: 147
flesch: 31
cache: cache/cord-279197-cesemos0.txt
txt: txt/cord-279197-cesemos0.txt
summary:
  In this journal, Yan et al 2 discussed the use of traditional Chinese medicine therapies with cancer patients afflicted with COVID-19. They also raised an alarm about therapies like massage and acupuncture that involve close contact with patients, and suggest they be rigidly considered or forbidden for cancer patients in endemic areas, with stronger personal protection provisions for both patients and therapists.


id: cord-135406-ztgrxucb
author: Ben-Michael, Eli
title: A trial emulation approach for policy evaluations with group-level longitudinal data
date: 2020-11-11
extension: .txt
mime: text/plain
words: 4311
sentence: 201
flesch: 49
cache: cache/cord-135406-ztgrxucb.txt
txt: txt/cord-135406-ztgrxucb.txt
summary:
  4 5 In this paper, we argue that policy evaluations using panel data need to take a similarly careful approach to study design, which we refer to as policy trial emulation. We now describe key steps in conducting policy trial emulation, which are necessary and obvious when designing a randomized trial and are becoming more common in the design of nonexperimental studies.


id: cord-267608-0odu8lus
author: Chen, Daohong
title: Innovative highlights of clinical drug trial design
date: 2020-06-03
extension: .txt
mime: text/plain
words: 4167
sentence: 132
flesch: 23
cache: cache/cord-267608-0odu8lus.txt
txt: txt/cord-267608-0odu8lus.txt
summary:
  Clinical trial plays an indispensable role in evaluating efficacy and safety of therapeutic agents prior to marketing for human use, and has been constantly co-evolving along with the dynamic interactions between cutting-edge scientific discoveries and regulatory policy updating [2, 3] . In this light, the article herein highlights an array of outstanding developments in the perspective of drug trial design, being corroborated by notable successes in the clinical settings.


id: cord-331206-m938suxh
author: Rodgers, F.
title: Missing clinical trial data: the knowledge gap in the safety of potential COVID-19 drugs
date: 2020-06-03
extension: .txt
mime: text/plain
words: 4318
sentence: 188
flesch: 41
cache: cache/cord-331206-m938suxh.txt
txt: txt/cord-331206-m938suxh.txt
summary:
  However, availability of safety information is limited by a lack of timely reporting of clinical trial results on public registries or through academic publication. Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%).


id: cord-324607-rpwccvqi
author: Rojek, Amanda M
title: Core Minimal Datasets to Advance Clinical Research for Priority Epidemic Diseases
date: 2020-02-15
extension: .txt
mime: text/plain
words: 1261
sentence: 43
flesch: 29
cache: cache/cord-324607-rpwccvqi.txt
txt: txt/cord-324607-rpwccvqi.txt
summary:
  Among the noteworthy successes of vaccine trials, and the commendable efforts to implement clinical treatment trials during Ebola outbreaks, we should also focus on strengthening the collection and curation of epidemiological and observational data that can improve the conception and design of clinical research. Any diagnostics, drugs, or vaccines that are developed as a result of this and other initiatives, such as the Coalition for Epidemic Preparedness Innovation, will need to be fully evaluated in diagnostic evaluation studies or phase II and III clinical trials.


id: cord-004647-0fuy5tlp
author: Patson, Noel
date: 2020-03-20
extension: .txt
mime: text/plain
words: 5666
sentence: 221
flesch: 34
cache: cache/cord-004647-0fuy5tlp.txt
txt: txt/cord-004647-0fuy5tlp.txt
title:
  Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials

summary:
  Geneva, World Health Organization Treatment of uncomplicated and severe malaria during pregnancy Methodology of assessment and reporting of safety in anti-malarial treatment efficacy studies of uncomplicated falciparum malaria in pregnancy: a systematic literature review Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration Statement: updated guidelines for reporting parallel group randomised trials Superiority, equivalence, and non-inferiority trials The statistical content of published medical research: some implications for biomedical education Use of statistical analysis in the The analysis of multivariate longitudinal data: a review Modeling laboratory data from clinical trials Statistical methods for evaluating safety in medical product development The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies A model for the distribution of daily number of births in obstetric clinics based on a descriptive retrospective study Some simple robust methods for the analysis of recurrent events An approach to integrated safety analyses from clinical studies Analysis of adverse events in drug safety: a multivariate approach using stratified quasi-least squares A framework for the design, conduct and interpretation of randomised controlled trials in the presence of treatment changes Correcting for non-compliance in randomized trials using structural nested mean models Addressing complications of intention-to-treat analysis in the combined presence of all-or-none treatment-noncompliance and subsequent missing outcomes Intention-to-treat meets missing data: implications of alternate strategies for analyzing clinical trials data Estimating treatment effects in randomised controlled trials with non-compliance: a simulation study Graphical approaches to the analysis of safety data from clinical trials Bayesian methods for design and analysis of safety trials Recent advances in methodology for clinical trials in small populations: the InSPiRe project Lessons learned from IDeAl-33 recommendations from the IDeAl-net about design and analysis of small population clinical trials Applicability and added value of novel methods to improve drug development in rare diseases Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective Analysis and reporting of adverse events in randomised controlled trials: a review Effect of repeated treatment of pregnant women with sulfadoxine-pyrimethamine and azithromycin on preterm delivery in Malawi: a randomized controlled trial Intermittent preventive treatment of malaria with sulphadoxinepyrimethamine during pregnancy in Burkina Faso: effect of adding a third dose to the standard two-dose regimen on low birth weight, anaemia and pregnancy outcomes Superiority of 3 over 2 doses of intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in mali: a randomized controlled trial Efficacy of malaria prevention during pregnancy in an area of low and unstable transmission: an individually-randomised placebo-controlled trial using intermittent preventive treatment and insecticide-treated nets • fast, convenient online submission • thorough peer review by experienced researchers in your field • rapid publication on acceptance • support for research data, including large and complex data types • gold Open Access which fosters wider collaboration and increased citations maximum visibility for Choose BMC and benefit from: in the Kabale Highlands, southwestern Uganda Intermittent preventive treatment with sulfadoxine-pyrimethamine versus weekly chloroquine prophylaxis for malaria in pregnancy in Honiara, Solomon Islands: a randomised trial Cotrimoxazole prophylaxis versus mefloquine intermittent preventive treatment to prevent malaria in HIV-infected pregnant women: two randomized controlled trials Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial Effectiveness of co-trimoxazole to prevent Plasmodium falciparum malaria in HIV-positive pregnant women in sub-saharan Africa: an open-label, randomized controlled trial Safety of daily Co-trimoxazole in pregnancy in an area of changing malaria epidemiology: a phase 3b randomized controlled clinical trial Intermittent screening and treatment or intermittent preventive treatment with dihydroartemisinin-piperaquine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for the control of malaria during pregnancy in western Kenya: an open-label, three-group, randomised controlled superiority trial Sulphadoxine-pyrimethamine plus azithromycin for the prevention of low birthweight in Papua New Guinea: a randomised controlled trial dihydroartemisinin-piperaquine for the prevention of malaria in pregnancy Efficacy and safety of azithromycin-chloroquine versus sulfadoxine-pyrimethamine for intermittent preventive treatment of Plasmodium falciparum malaria infection in pregnant women in Africa: an open-label, randomized trial Intermittent preventive treatment with dihydroartemisinin-piperaquine for the prevention of malaria among HIV-infected pregnant women Chloroquine as weekly chemoprophylaxis or intermittent treatment to prevent malaria in pregnancy in Malawi: a randomised controlled trial Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria Monthly sulfadoxine-pyrimethamine versus dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnancy: a double-blind, randomised, controlled, superiority trial Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations Utrecht University, Utrecht, The Netherlands. The findings are useful to advance the development of standardized guidelines for safety data statistical analysis in analysis in anti-malarial drugs in pregnancy trials and related fields.


id: cord-018677-gmitz3gg
author: Clemens, John D.
title: Sequential stages of clinical trials and overview of issues to be considered
date: 2005
extension: .txt
mime: text/plain
words: 6434
sentence: 228
flesch: 32
cache: cache/cord-018677-gmitz3gg.txt
txt: txt/cord-018677-gmitz3gg.txt
summary:
  The promulgation of GCP has had several implications for vaccine trials in developing countries. Indeed, a common tactic in older Phase III vaccine trials was to evaluate adverse events only in a small subsample of the total trial population, obviating the possibility of detecting rare but potentially significant side-effects.


id: cord-287507-1xb2hipt
author: Rubio-San-Simón, A.
date: 2020-05-29
extension: .txt
mime: text/plain
words: 2285
sentence: 102
flesch: 43
cache: cache/cord-287507-1xb2hipt.txt
txt: txt/cord-287507-1xb2hipt.txt
title:
  Challenges in early phase clinical trials for childhood cancer during the COVID-19 pandemic: a report from the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

summary:
  Although there are multiple publications about generic emergency preparedness in health settings, there is minimal information focusing on clinical trial sites [16, 17] and we provide recommendations on this respect (Fig. 1) . The European Medicines Agency and the Spanish Agency of Medicines and Medical Devices have issued guidelines on the management of clinical trial activities [7, 8] Both are aligned in the intention to guarantee trial activity, patient safety, and action traceability.


id: cord-284502-nesvd10a
author: Singh, Arjun Gurmeet
title: Clinical trials during COVID‐19
date: 2020-05-02
extension: .txt
mime: text/plain
words: 1604
sentence: 70
flesch: 42
cache: cache/cord-284502-nesvd10a.txt
txt: txt/cord-284502-nesvd10a.txt
summary:
  Sponsors need to take into account the national guidelines and restrictive measures imposed including limitations of trial participants and staff confinements and their ability to perform visits, interviews and forms, and notification of adverse effects. Ensuring safety of trial participants is paramount and decisions should be taken on an individual participant basis focusing on the potential benefit.


id: cord-281400-ho2m7nqn
author: Nguyen, Van Thu
date: 2020-10-21
extension: .txt
mime: text/plain
words: 2316
sentence: 91
flesch: 40
cache: cache/cord-281400-ho2m7nqn.txt
txt: txt/cord-281400-ho2m7nqn.txt
title:
  Research response to COVID-19 needed better coordination and collaboration: a living mapping of registered trials

summary:
  Conclusion This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Our data are obtained from the WHO International Clinical Trials Registry Platform (ICTRP) (https://www.who.int/ictrp/en/), an international registry that assembles information on clinical trials registered in 17 primary registries (4) .


id: cord-279637-n8acd6hj
author: van der Plas, J.L.
title: How to expedite early phase SARS‐CoV‐2 vaccine trials in pandemic setting – a practical perspective
date: 2020-06-19
extension: .txt
mime: text/plain
words: 987
sentence: 41
flesch: 28
cache: cache/cord-279637-n8acd6hj.txt
txt: txt/cord-279637-n8acd6hj.txt
summary:
  This will allow the investigator to maintain an ongoing pool of (pre)screened healthy participants that are ready to be enrolled in vaccine trials. The relevant immune assays in vaccine trials will typically depend on the mechanism of action of the vaccine candidate and possible known correlates of protection.


id: cord-345762-khvcoqti
author: Scott, Ian A.
title: COVID‐19 pandemic and the tension between the need to act and the need to know
date: 2020-08-06
extension: .txt
mime: text/plain
words: 3441
sentence: 103
flesch: 30
cache: cache/cord-345762-khvcoqti.txt
txt: txt/cord-345762-khvcoqti.txt
summary:
  This author also spoke to the media extolling the virtues of AC in all COVID-19 patients admitted to intensive care and announced that the Mount Sinai hospital system had changed its protocols to begin giving such patients therapeutic doses of AC. Hopefully, the same problems will not occur with remdesivir, whichdespite limited and conflicting evidence of clinical improvement from only two placebo-controlled RCT 19, 20 and one non-controlled cohort study 5has now become a 'standard of care' in the United States for COVID-19 patients with severe pneumonia.


id: cord-335198-qp964238
author: Kotsimbos, T.
title: Pandemic Treatments on Trial: The bigger picture
date: 2020-08-03
extension: .txt
mime: text/plain
words: 2728
sentence: 92
flesch: 35
cache: cache/cord-335198-qp964238.txt
txt: txt/cord-335198-qp964238.txt
summary:
  Negotiating the deep chasm between frameworks is a key challenge for treating clinicians so that we don't get lost in a multitude of poorly controlled studies but leap towards a hierarchy of larger clinical trials arranged according to likelihood of success based on early but uncertain signals in smaller numbers of patients. From early, uncontrolled results that reported a clinical improvement in 68% of 53 analyzable patients (10) through to a negative RCT study result involving 236 patients which was stopped early due to reduced case numbers in China resulting in a trial with reduced power to detect any smaller clinically significant benefit with any certainty (11) to further preliminary reports of potentially positive results in larger trials sponsored by the remdisivir patent holder (12) .


id: cord-263088-zj14ro5j
author: DiPaola, Joshua D.
date: 2020-06-17
extension: .txt
mime: text/plain
words: 7521
sentence: 247
flesch: 44
cache: cache/cord-263088-zj14ro5j.txt
txt: txt/cord-263088-zj14ro5j.txt
title:
  Investigating the use of sensory information to detect and track prey by the Sunda pangolin (Manis javanica) with conservation in mind

summary:
  Southeast Asia Regional Office Overview of pangolin trade in Southeast Asia in Proceedings of the Workshop on Trade and Conservation of Pangolins Native to South and Southeast Asia Molecular tracing of confiscated pangolin scales for conservation and illegal trade monitoring in Southeast Asia An overview of pangolin trade in The role of pangolins in ecosystems in Pangolins: Science, Society and Conservation Scaling up pangolin conservation in IUCN SSC Pangolin Specialist Group Conservation Action Plan Evaluating methods for detecting and monitoring pangolin (Pholidata: Manidae) populations. However, due to the extreme difficulty of testing pangolins in controlled settings and the Sunda pangolin's status as a critically endangered mammal on the verge of extinction, we present these results as a case study.


id: cord-309582-ihrj84hr
author: AlNaamani, Khalid
title: Medical research during the COVID-19 pandemic
date: 2020-08-06
extension: .txt
mime: text/plain
words: 4052
sentence: 151
flesch: 31
cache: cache/cord-309582-ihrj84hr.txt
txt: txt/cord-309582-ihrj84hr.txt
summary:
  However, these clinical trials may require modifications due a pandemic such as this one to ensure the rights, safety, and wellbeing of participants as well as medical staff involved in the conduction of clinical trials. Clinical trials initiated during the pandemic must be time-efficient and flexible due to high contagiousness of severe acute respiratory syndrome coronavirus 2, the significant number of reported deaths, and time constraints needed to perform high quality clinical trials, enrolling adequate sample sizes.


id: cord-005705-j765ruj1
author: Dreyfuss, Didier
title: Is it better to consent to an RCT or to care?: Μηδεν αγαν (“nothing in excess”)
date: 2004-12-17
extension: .txt
mime: text/plain
words: 7512
sentence: 311
flesch: 42
cache: cache/cord-005705-j765ruj1.txt
txt: txt/cord-005705-j765ruj1.txt
summary:
  United States Government Printing Office Unraveling the Tuskegee study of untreated syphilis The therapeutic orientation to clinical trials The integral role of clinical research in clinical care Is informed consent always necessary for randomized, controlled trials? Resolving discordant meta-analyses Clinically significant gastrointestinal bleeding in critically ill patients with and without stress-ulcer prophylaxis Clinicians' approaches to mechanical ventilation in acute lung injury and ARDS The price of autonomy Principles of medical ethics Why immunomodulatory therapies have not worked in sepsis Safeguarding patients in clinical trials with high mortality rates Is the concept of informed consent applicable to clinical research involving critically ill patients? Ethical considerations for research in critically ill patients Do surrogate decision makers provide accurate consent for intensive care research?


id: cord-302448-2r4rtixg
author: Kharma, Nadir
date: 2020-09-07
extension: .txt
mime: text/plain
words: 1837
sentence: 96
flesch: 47
cache: cache/cord-302448-2r4rtixg.txt
txt: txt/cord-302448-2r4rtixg.txt
title:
  Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial

summary:
  key: cord-302448-2r4rtixg authors: Kharma, Nadir; Roehrig, Stefan; Shible, Ahmed Atef; Elshafei, Moustafa Sayed; Osman, Dema; Elsaid, Ingi Mohamed; Mustafa, Salma Faisal; Aldabi, Asjad; Smain, Osamah A.M.; Lance, Marcus D. title: Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial date: 2020-09-07 journal: Trials DOI: 10.1186/s13063-020-04689-1 sha: doc_id: 302448 cord_uid: 2r4rtixg OBJECTIVES: To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation. The protocol is registered before starting subject recruitment under the title: “Anticoagulation in patients suffering from COVID-19 disease.


id: cord-030531-4uucx9ss
author: Randremanana, Rindra Vatosoa
date: 2020-08-17
extension: .txt
mime: text/plain
words: 8052
sentence: 311
flesch: 45
cache: cache/cord-030531-4uucx9ss.txt
txt: txt/cord-030531-4uucx9ss.txt
title:
  An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial

summary:
  The routine samples taken from trial patients will be labelled with a collection label which will not contain a patient trial identifier. The majority of plague patients are treated at the CSB level.


id: cord-031315-p7jb4gf2
author: Kong, Qing
date: 2020-09-03
extension: .txt
mime: text/plain
words: 8386
sentence: 389
flesch: 48
cache: cache/cord-031315-p7jb4gf2.txt
txt: txt/cord-031315-p7jb4gf2.txt
title:
  Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial

summary:
  Trial participants, care providers including attending physician and nurse, outcome assessors including PI and sub-PI, and data analysts will be blinded after the assignment of interventions. Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} Any modification to the protocol which may impact the conduct of the study and the potential benefit of the patients will be reported to ethic committee.


id: cord-004339-7nwpic3d
author: Rennie, Katherine J.
date: 2020-02-13
extension: .txt
mime: text/plain
words: 8417
sentence: 362
flesch: 39
cache: cache/cord-004339-7nwpic3d.txt
txt: txt/cord-004339-7nwpic3d.txt
title:
  Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

summary:
  Keywords: Nasal septum, Nasal obstruction, Septoplasty, Turbinates, Mometasone furoate, Clinical trial, Cost-effectiveness, Process evaluation Background Septoplasty is surgery to straighten the nasal partition between the two nostrils (the septum). The estimation of a preference-based measure of health from the SF-36 The use of nasal spirometry as an objective measure of nasal septal deviation and the effectiveness of septal surgery Use of peak nasal inspiratory flowmetry and nasal decongestant to evaluate outcome of septoplasty with radiofrequency coblation of the inferior turbinate The accuracy and reproducibility of rhinospirometry in detecting flow asymmetry in a nasal cavity model The value of bilateral simultaneous nasal spirometry in the assessment of patients undergoing septoplasty SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials Nasal septal surgery: evaluation of symptomatic and general health outcomes Patterns of treatment effects in subsets of patients in clinical trials Reporting attrition in randomised controlled trials Practice based, longitudinal, qualitative interview study of computerised evidence based guidelines in primary care The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial Distributed decision making: the anatomy of decisions-in-action Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials Capturing users' experiences of participating in cancer trials Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit A feasibility study incorporating a pilot randomised controlled trial of oral feeding plus pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer (TUBE trial): study protocol The constant comparative method of qualitative analysis The quality of qualitative research.


id: cord-334433-oudvxb4d
author: Beane, Joal D.
title: Conducting Clinical Trials in the Time of a Pandemic
date: 2020-06-08
extension: .txt
mime: text/plain
words: 1884
sentence: 97
flesch: 41
cache: cache/cord-334433-oudvxb4d.txt
txt: txt/cord-334433-oudvxb4d.txt
summary:
  Responses to mitigate the effects of the pandemichave included: 1) thedevelopment of strategies to support research programs during unforeseen economic loss, 2)establishment of institutionalguidelines for clinical trials, 3)measures to ensure a healthy clinical research team, 4) useof innovative technologies to maintain access to clinical trials, 5) amendment of protocols to avoid costly trial closures, and 6) the strategic reopening of suspended clinical trials. key: cord-334433-oudvxb4d authors: Beane, Joal D.; Dedhia, Priya H.; Ejaz, Aslam; Contreras, Carlo M.; Cloyd, Jordan M.; Tsung, Allan; Pawlik, Timothy M. title: Conducting Clinical Trials in the Time of a Pandemic date: 2020-06-08 journal: Ann Surg DOI: 10.1097/sla.0000000000004114 sha: doc_id: 334433 cord_uid: oudvxb4d nan Mini Abstract: The novel human coronavirus (SARS-CoV-2) has created formidable challenges to the conduct of clinical trials and research.


id: cord-032607-bn8g02gi
author: Wake, Melissa
date: 2020-09-24
extension: .txt
mime: text/plain
words: 8364
sentence: 319
flesch: 39
cache: cache/cord-032607-bn8g02gi.txt
txt: txt/cord-032607-bn8g02gi.txt
title:
  Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

summary:
  Each wave of GenV data collection will likely take 2 years from first to last participant to collect measures that are predicated on age milestones; thus, trials data would be available much sooner for trial interventions conducted later than earlier in a data collection wave. If feasibility (potentially demonstrated through pilot studies) and mutual alignment appear likely [29] , the trial would proceed to a partnering agreement that defines at least the following 8 items: 1) Which GenV trial model is being followed; 2) Design and high-level (or draft) protocol; 3) Timelines; 4) Data sharing and governance plans; 5) Status of ethical approval; 6) Communication with participants, including information statement and consent; 7) Trial oversight and 8) Capacity assessment, including trial quality, human resource and funding.


id: cord-344491-93ggxzxu
author: Husebo, Bettina Sandgathe
date: 2020-06-09
extension: .txt
mime: text/plain
words: 8729
sentence: 337
flesch: 35
cache: cache/cord-344491-93ggxzxu.txt
txt: txt/cord-344491-93ggxzxu.txt
title:
  LIVE@Home.Path—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial

summary:
  Role of caregiver training and risk factors Cost effectiveness of a training program for dementia carers Caregiver burden among dementia patient caregivers: a review of the literature Evidence of what works to support and sustain care at home for people with dementia: a literature review with a systematic approach A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes A multidimensional home-based care coordination intervention for elders with memory disorders: the Maximizing Independence at Home (MIND) pilot randomized trial Comprehensive home-based care coordination for vulnerable elders with dementia: Maximizing Independence at Home-Plus-Study protocol MIND at Home-Streamlined: study protocol for a randomized trial of home-based care coordination for persons with dementia and their caregivers All interventions are complex, but some are more complex than others: using iCAT_SR to assess complexity Theoretical foundations guiding culture change: the work of the Partnerships in Dementia Care Alliance Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR) Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework COSMOS-improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial The effect of a multicomponent intervention on quality of life in residents of nursing homes: a randomized controlled trial (COSMOS) Deprescribing antihypertensive treatment in nursing home patients and the effect on blood pressure Implementing a novel strategy for interprofessional medication review using collegial mentoring and systematic clinical evaluation in nursing homes (COSMOS) Description of an advance care planning intervention in nursing homes: outcomes of the process evaluation Advance care planning in nursing homes-improving the communication among patient, family, and staff: results from a cluster randomized controlled trial (COSMOS) Results of the latter study are highly anticipated due to the potential for effective system-level approaches to dementia care


id: cord-286288-gduhterq
author: Spitzer, Ernest
title: Cardiovascular Clinical Trials in a Pandemic: Immediate Implications of Coronavirus Disease 2019
date: 2020-05-01
extension: .txt
mime: text/plain
words: 2761
sentence: 131
flesch: 32
cache: cache/cord-286288-gduhterq.txt
txt: txt/cord-286288-gduhterq.txt
summary:
  Two general principles governing the execution of clinical trials are ensuring patient safety and clinical trial integrity. [14] Planning, executing and reporting clinical trials designed for the approval of (or to extend indications for) drugs, biological products, devices and combinations thereof, are highly regulated activities.


id: cord-346842-ip4i3bdk
author: Jeon, JuYeun
title: The Impact of COVID-19 on the Conduct of Clinical Trials for Medical Products in Korea
date: 2020-09-07
extension: .txt
mime: text/plain
words: 4169
sentence: 166
flesch: 42
cache: cache/cord-346842-ip4i3bdk.txt
txt: txt/cord-346842-ip4i3bdk.txt
summary:
  Kyungpook National University Hospital, located in Daegu, and Seoul Medical Center in Seoul, which operated a professional negative-pressure isolation ward took part in the largest number of COVID-19 clinical trials in Korea, with 4 trials each. The number of clinical trials conducted in Korea continues to increase and an increasing proportion focus on severe and rare incurable diseases.


id: cord-334667-0cah15lg
author: Arabi, Yaseen M.
date: 2020-01-03
extension: .txt
mime: text/plain
words: 3838
sentence: 157
flesch: 45
cache: cache/cord-334667-0cah15lg.txt
txt: txt/cord-334667-0cah15lg.txt
title:
  Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

summary:
  To overcome these challenges, we designed the MIRACLE trial as a recursive two-stage adaptive trial, which is a relatively new method for group sequential trials The trial is designed as a recursive, two-stage, group sequential randomized trial.


id: cord-326331-g4o3forj
author: Rai, Ansaar T
date: 2020-06-30
extension: .txt
mime: text/plain
words: 3463
sentence: 161
flesch: 39
cache: cache/cord-326331-g4o3forj.txt
txt: txt/cord-326331-g4o3forj.txt
title:
  Neuroendovascular clinical trials disruptions due to COVID-19 potential future challenges and opportunities

summary:
  All were involved in neurovascular clinical trials as site principal investigators and six were leading clinical trials as national principal investigators. Similar guidelines were issued by the European Medicines Agency on the management of clinical trials during the COVID-19 pandemic on April 28, 2020 (https:// ec.


id: cord-344705-co0nk7pt
author: Eichler, Hans‐Georg
title: Clinical trials for Covid‐19: can we better use the short window of opportunity?
date: 2020-05-14
extension: .txt
mime: text/plain
words: 2990
sentence: 111
flesch: 38
cache: cache/cord-344705-co0nk7pt.txt
txt: txt/cord-344705-co0nk7pt.txt
summary:
  key: cord-344705-co0nk7pt authors: Eichler, Hans‐Georg; Cavaleri, Marco; Enzmann, Harald; Scotti, Francesca; Sepodes, Bruno; Sweeney, Fergus; Vamvakas, Spiros; Rasi, Guido title: Clinical trials for Covid‐19: can we better use the short window of opportunity? date: 2020-05-14 journal: Clin Pharmacol Ther DOI: 10.1002/cpt.1891 sha: doc_id: 344705 cord_uid: co0nk7pt This is not surprising; in the context of epidemics, academic groups, public health authorities, and funding bodies generally step up in their contribution to the crisis including design and conduction of clinical trials.


id: cord-331133-6zu44fn2
author: Riley, William T
title: Rapid, responsive, relevant (R3) research: a call for a rapid learning health research enterprise
date: 2013-05-10
extension: .txt
mime: text/plain
words: 3435
sentence: 123
flesch: 30
cache: cache/cord-331133-6zu44fn2.txt
txt: txt/cord-331133-6zu44fn2.txt
summary:
  The NIH Health Care System Collaboratory (HCSC) offers an important resource for rapid research. [45] also provides the opportunity to leverage these large data sets for rapid research.


id: cord-331487-jh34klbg
author: Sivapalan, Pradeesh
date: 2020-06-10
extension: .txt
mime: text/plain
words: 6407
sentence: 315
flesch: 42
cache: cache/cord-331487-jh34klbg.txt
txt: txt/cord-331487-jh34klbg.txt
title:
  Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial

summary:
  The length of hospitalisation is observed to be relatively long, 10-15 days (3) , which in itself is a problem as hospitals can quickly reach the maximum capacity for hospitalisation and the proportion of patients who become critically ill have, based on the observations reported so far, had a mortality rate of> 60% (4), and overall mortality for admitted patients in China with COVID-19 infection is apparently unusually high for viral respiratory tract infections with an estimate of 25% (2). Annual monitoring after 5 years of treatment is recommended, however in risk patients initially annual control, see also Chloroquine derivatives (inflammatory rheumatic diseases), side effects.


id: cord-352177-05sku8a8
author: Pahus, Laurie
date: 2020-08-13
extension: .txt
mime: text/plain
words: 4118
sentence: 164
flesch: 31
cache: cache/cord-352177-05sku8a8.txt
txt: txt/cord-352177-05sku8a8.txt
title:
  Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

summary:
  Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results. The recruitment and retention of patients in clinical trials is challenging, but necessary, because it is the cornerstone of medical evidence production.


id: cord-356040-qdpkidn8
author: Ghazawi, Feras M.
date: 2020-07-03
extension: .txt
mime: text/plain
words: 4170
sentence: 132
flesch: 23
cache: cache/cord-356040-qdpkidn8.txt
txt: txt/cord-356040-qdpkidn8.txt
title:
  Infection risk of dermatologic therapeutics during the COVID‐19 pandemic: an evidence‐based recalibration

summary:
  We performed a literature review to approximate the risk of SARS‐CoV‐2 infection, including available data on the roles of relevant cytokines, cell subsets, and their mediators in eliciting an optimal immune response against respiratory viruses in murine gene deletion models and humans with congenital deficiencies were reviewed for viral infections risk and if possible coronaviruses specifically. One systematic review evaluating the off-label use of azathioprine found mild infections reported in 0.36% of patients and severe infections in only 0.30% of patients 70 (Table 3 ).


id: cord-348244-1py0k53e
author: Buyse, Marc
title: Central statistical monitoring of investigator-led clinical trials in oncology
date: 2020-06-23
extension: .txt
mime: text/plain
words: 4053
sentence: 135
flesch: 37
cache: cache/cord-348244-1py0k53e.txt
txt: txt/cord-348244-1py0k53e.txt
summary:
  A Risk-Based Approach to Monitoring Data-driven risk identification in phase III clinical trials using central statistical monitoring Available at https ://trans celer atebi ophar mainc .com/asset s/rbm-asset s/ (Accessed 14 A statistical approach to central monitoring of data quality in clinical trials Linear mixed-effects models for central statistical monitoring of multicenter clinical trials Use of the betabinomial model for central statistical monitoring of multicenter clinical trials A hercule poirot of clinical research Detection of atypical data in multicenter clinical trials using unsupervised statistical monitoring Statistical monitoring of data quality and consistency in the Stomach Cancer Adjuvant Multi-institutional The control of the false discovery rate in multiple testing under dependency Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 vs. UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trial Fraud in clinical trials The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials Guidance for industry, investigators, and institutional review boards. The contribution of clinical trials to the overall costs of drug development is not known with precision, but recent estimates suggest that pivotal clinical trials leading to FDA approval have a median cost of US$ 19 million; such costs are even higher in oncology and cardiovascular medicine, as well as in trials with a long-term clinical outcome, such as survival


id: cord-350062-6xsh2pis
author: Juul, Sophie
date: 2020-09-17
extension: .txt
mime: text/plain
words: 9056
sentence: 443
flesch: 47
cache: cache/cord-350062-6xsh2pis.txt
txt: txt/cord-350062-6xsh2pis.txt
title:
  Interventions for treatment of COVID-19: A living systematic review with meta-analyses and trial sequential analyses (The LIVING Project)

summary:
  We planned to conduct aggregate data meta-analyses, trial sequential analyses, network meta-analysis, and individual patient data meta-analyses. We used trial sequential analysis to control for random errors [23]


id: cord-160526-27kmder5
author: Meyer, R. Daniel
title: Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
date: 2020-05-21
extension: .txt
mime: text/plain
words: 9272
sentence: 357
flesch: 36
cache: cache/cord-160526-27kmder5.txt
txt: txt/cord-160526-27kmder5.txt
summary:
  Its effects on trial data create multiple potential statistical issues. Statistical analyses of trial data will then be properly adjusted for pandemic effects.


id: cord-310272-utqyuy0n
author: Zamani, Efpraxia D.
title: Appropriating Information Technology Artefacts through Trial and Error: The Case of the Tablet
date: 2020-09-18
extension: .txt
mime: text/plain
words: 13983
sentence: 477
flesch: 42
cache: cache/cord-310272-utqyuy0n.txt
txt: txt/cord-310272-utqyuy0n.txt
summary:
  In setting their goals, tablet users may be influenced by reviews, advertisements, others' experiences as well as their own past experience with similar or dissimilar devices. Trial and error is primarily based on exploitation; as our findings show, tablet users seek to implement tentative solutions based on what they know and their experiences.


id: cord-269716-x3b0qphd
author: Hopper, Lydia M.
title: Problem solving flexibility across early development
date: 2020-08-26
extension: .txt
mime: text/plain
words: 10333
sentence: 340
flesch: 51
cache: cache/cord-269716-x3b0qphd.txt
txt: txt/cord-269716-x3b0qphd.txt
summary:
  Although 2-year-olds struggle with more cognitively demanding physical adaptation of these looking-time studies, by 3 years of age children are able to track a falling object behind an occluder, correctly select a door to open, and reach for the fallen object (Berthier, DeBlois, Poirier, Novak, & Clifton, 2000) . To determine the diversity of action sequences children used, we calculated the diversity index of their responses (Shannon & Weaver, 1949) .


id: cord-338588-rc1h4drd
author: Li, Xuanyi
title: Seven decades of chemotherapy clinical trials: a pan-cancer social network analysis
date: 2020-10-16
extension: .txt
mime: text/plain
words: 6869
sentence: 232
flesch: 36
cache: cache/cord-338588-rc1h4drd.txt
txt: txt/cord-338588-rc1h4drd.txt
summary:
  While 99.4% of authors were directly or indirectly connected by 2018, our results indicate a tendency to predominantly connect with others in the same or similar fields, as well as an increasing disparity in author impact and number of connections. We considered existing metrics for measuring author impact 59-62 , but ultimately proceeded with our own formulation given some of the unique considerations of prospective clinical trials and their impact.


