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ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic has 

necessitated that medical writers adapt their work practices 

quickly to assist with the preparation of documentation related 

to COVID-19 research and clinical trials, as well as to assess the 

impact of the pandemic on other clinical trials. Complexities 

and challenges medical writers have faced include the growing 

scientific knowledge of the virus, the burgeoning global foot-

print of the pandemic, and the evolving regulatory landscape 

on both COVID-19 and non-COVID-19 clinical trials. 

INTRODUCTION
When cases of a novel coronavirus, severe acute respiratory 

syndrome coronavirus 2 (SARS-CoV-2), surfaced in the Hubei 

province of China in December 2019, leading to the outbreak 

of a complex respiratory illness (later coined coronavirus dis-

ease 2019 [COVID-19]), the world watched to see what would 

happen next. Many were cautiously optimistic that the virus 

would remain endemic to the region of the outbreak, as Middle 

East respiratory syndrome (MERS) had in 2012,1 or, at worst, 

that it could be contained as the severe acute respiratory syn-

drome (SARS) epidemic had been in 2003.2 The challenge of 

trying to contain the novel coronavirus was complicated by 

a lack of clarity on exactly how it was transmitted3; it was not 

until January 19, 2020, that the World Health Organization 

(WHO) announced that there was evidence of human-to-

human transmission of the virus.4

 This article provides a brief overview of the COVID-19 pan-

demic time course, the regulatory actions taken to allow for 

unprecedented rapid development of diagnostic and therapeu-

tic products in the United States for COVID-19, and the impact 

of the pandemic on medical writers in the biotech and phar-

maceutical industry. 

Arrival of COVID-19 in the United States and Initial 
Impact on Biotech and Pharmaceutical Companies
A recent retrospective analysis of SARS-CoV-2–reactive anti-

bodies in archived blood donation samples, spanning 9 states 

from the East to West coasts, indicates that COVID-19 may 

have been widely introduced into the United States as early 

as mid-December 2019.5 Despite the first cases of COVID-19 

being observed in the United States and Europe on January 

19 and 24, 2020, respectively (Figure),4,6 operations for bio-

tech and pharmaceutical companies in the United States 

continued as normal into February. On February 26 and 27, a 

large conference was hosted by a biotech company in Boston, 

Massachusetts, which was later deemed a “superspreader” 

event,7 with approximately 100 diagnosed cases after the event 

ultimately being associated by genomic analysis with up to 

330,000 subsequent cases. Following this event, biotech and 

pharmaceutical companies across the United States, particu-

larly those in states experiencing a surge in cases, began enact-

ing business continuity plans per local and state guidelines, 

including sheltering in place to the extent possible. Meanwhile, 

a shortage of personal protective equipment led many compa-

nies to donate their current laboratory supplies to local health 

care centers in surge states in early spring.8 For those employ-

ees who did have to go on site at their companies to perform 

experiments, a lack of COVID-19 testing supplies contributed 

to uncertainty for how to continue critical research while mini-

mizing the risk for virus spread. 

 With guidelines on safe business operation being issued 

at the state level, it was not immediately clear how planned 

research and development (R&D) activities would be impacted 

or for how long. To address local social distancing require-

ments, some companies had to prioritize laboratory research 

for COVID-19 and for certain conditions with unmet need.9 

It was also not immediately clear to what extent biotech and 

pharmaceutical companies, and the venture capital firms that 

finance their R&D activities, would invest in developing treat-

Jeanette Towles, MA  / Synterex, Inc., Boston, MA 

A Brief History of the COVID-19 Pandemic and 
Current Efforts to Combat It

R
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S
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A
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      AMWA Journal / V36 N2 / 2021 / amwa.org    65

ments for a novel virus that might not persist in the long term, 

based on evolving information on SARS-CoV-2 as well as prior 

SARS/MERS experience. These factors represented an initial 

threat to an industry that is largely dependent upon the con-

tinuous advancement of research.

Declaration of a Pandemic, the US Food and Drug 
Administration Response, and the Shift to Real-
Time Drug Development
Pursuant to a rise in the number, severity, and location of 

cases, a pandemic was formally declared on March 11, 2020, 

by WHO.10 The Director of WHO urged countries worldwide to 

change the course of the pandemic and to “First, prepare and 

be ready. Second, detect, protect and treat. Third, reduce trans-

mission. Fourth, innovate and learn.”

 As more became known publicly about the clinical course 

of the virus, many global biotech and pharmaceutical compa-

nies sprang into action to see if existing technology or assets 

could contribute to a cure or a treatment for COVID-19 or its 

sequelae. These companies included those already develop-

ing vaccines, those developing therapeutics who entered vac-

cine development de novo, those repurposing existing antiviral 

and other drugs, and those developing new drugs. Several 

companies partnered with other biotech companies or aca-

demic institutions to optimize efficiency. The sequence of 

the virus was first made public in early January 2020,4,11 and 

by late January, the US Food and Drug Administration (FDA) 

announced that it was “actively leveraging the vast breadth 

of the FDA’s expertise” and had “begun employing the full 

range of our public health authorities to facilitate the develop-

ment and availability of investigational medical products to 

help address this urgent public health situation.”12 On January 

31, 2020, the US Department of Health and Human Services 

declared that COVID-19 constituted a US public health emer-

gency and that an Emergency Use Authorization (EUA) was 

needed to mitigate the threat of COVID-19. This action enabled 

the FDA, in consultation with the National Institutes of Health 

and Centers for Disease Control and Prevention (CDC), to 

authorize the emergency use of unapproved medical products 

(Table 1).13,14 

 With so many companies advancing new COVID-19 pipe-

line assets, many of the biotech and pharmaceutical employ-

ees who were initially impacted by the halt of other clinical 

trials eventually were reassigned to COVID-19–related work.9 

First case of “viral 
pneumonia” 

reported in Wuhan, 
China

SARS-CoV-2 virus 
genomic 
sequence 

published and 
made public via 
WHO; 1st death 
from COVID-19 

reported in China

1st

vaccine 
VRBPACs 

and 
EUAs

WHO convenes 
diagnostics/
laboratories global 
expert network, 
announces protocol 
for RT-PCR for 
COVID-19 diagnostic; 
1st and 2nd cases 
reported outside of 
China in Thailand and 
Japan, respectively

1st COVID-19 
case reported 
in US; 1st case 
reported in EU; 
guidance on 
mask-wearing 
in public 
released by 
WHO

1st diagnostic 
RT-PCR tests 
available, 1st

diagnostic EUA 
in US; virus 
coined 
“COVID-19” by 
WHO

WHO 
declares 
COVID-19 
pandemic

EUA for 
HQ/CQ 
issued by 
US FDA, 
OWS 
launches, 
CTAP 
announced

EUA for 
HQ/CQ 
revoked; FDA 
issues 
guidance on 
vaccine 
development

EUA for 
remdesivir 
issued by US 
FDA (severe 
COVID/
hospitalized 
patients); 
FDA issues 
guidance on 
COVID trials

FDA issues 
guidance on 
conducting 
clinical trials 
during 
pandemic, 
announces 
suspension of 
domestic and 
foreign routine 
and BIMO 
inspections

EUA issued for 
convalescent 
plasma; FDA 
issues guidance 
on supply chain 
and 
inspections; 
EUA for 
remdesivir 
broadened

EUAs issued 
for 3 mAbs

FDA announces 
plans to resume  
domestic 
inspections; 
EUA issued for 
1st COVID 
testing of 
asymptomatic 
individuals

NIH 
announces 
ACTIV 
program

FDA issues 
EUA 
guidance for 
vaccines; 
approval of 
remdesivir 
for COVID-19 
treatment

Dec 
2020

Nov 
2020

Oct 
2020

Aug 
2020

Jul 
2020

Jun 
2020

May 
2020

Apr 
2020

Mar 
2020

Feb 
2020

Jan 
2020

31 
Dec 
2019

Figure. Timeline of key events associated with the COVID-19 pandemic. Sources: WHO,3,4,10 GenBank,11 FDA.15,18-22,24,33,47-49 

Abbreviations: ACTIV, Accelerating COVID-19 Therapeutic Interventions and Vaccines; BIMO, Biomedical Research Monitoring; COVID-19, novel coronavirus 2019;  
CQ, chloroquine; CTAP, Coronavirus Treatment Acceleration Program; EU, European Union; EUA, Emergency Use Authorization; FDA, Food and Drug Administration;  
HQ, hydroxychloroquine; mAb, monoclonal antibody; NIH, National Institutes of Health; OWS, Operation Warp Speed; RT, reverse transcription polymerase chain  
reaction; SARS-CoV-2, virus that causes coronavirus 2019 disease; US, United States; VRBPAC, Vaccines and Related Biological Products Advisory Committee; WHO, 
World Health Organization. 



66    AMWA Journal / V36 N2 / 2021 / amwa.org        

As the author experienced, and based on personal communi-

cation of the author with industry colleagues, medical writers 

set to work alongside researchers on manuscripts for COVID-

19 research, many times resulting in unprecedented rapid 

review and release of results in journals ahead of peer review 

to allow for real-time dissemination. Regulatory medical writ-

ers collaborated with cross-functional colleagues on investi-

gational new drug (IND) application and EUA documentation 

to enable clinical evaluation of diagnostic, therapeutic, and 

preventive products; others participated in conversations with 

contract research organizations (CRO) and sites, balancing 

operational feasibility and cost while implementing evolving 

regulatory guidance, to determine if certain non-COVID-19 

trials would be able to continue during the pandemic. 

 Although medical writers have connected with colleagues 

remotely via various electronic media for a long time, many 

recently have had to cope with a new shift in their workload 

and priorities. In addition, medical writers have had to change 

how and how often they communicate during the writing 

process to meet the demand of real-time drug development, 

oftentimes working in coauthoring environments or live meet-

ings rather than iteratively. 

Table 1. Global and United States COVID-19 Preventive and Therapeutic Initiatives 

Initiative Owner(s) Initiative Purpose

Various governments, scientists, 
businesses, civil societies, 
philanthropists, and global 
health organizations

The ACT Accelerator Global collaboration to accelerate the development, 
production, and equitable access to COVID-19 tests, 
treatments, and vaccines.38,39,a

WHO + global experts R&D Blueprint A global strategy and preparedness plan to fast-track the 
availability of effective tests, vaccines, and medicines that 
can be used to save lives and avert large-scale crises. Global 
Research Roadmap released in March 2020.40,41

WHO Solidarity II international 
clinical trial25,b

COVID-19 technical 
guidance: The Unity 
Studies: Early 
Investigation Protocols

Global collaboration led by WHO that promotes the 
implementation of serological surveys of SARS-CoV-2. 

Promotes standardized epidemiological, molecular, and 
serological methods to facilitate international comparisons so 
that both countries and the global community can collectively 
address knowledge gaps and inform an evidence-based 
COVID-19 response.42

US DHHS OWS Partnership among components of the DHHS, including the 
CDC, NIH, BARDA, and DoD with private firms and other 
federal agencies. Coordinates existing DHHS-wide efforts, 
including the NIH’s ACTIV partnership, NIH’s RADx initiative, 
and work by BARDA. Vaccine candidates from 3 companies 
are part of this initiative.43

FNIH ACTIV Public-private partnership to speed COVID-19 vaccine and 
treatment options.44

US DHHS, NIH COVPN Merged 4 existing NIAID-funded clinical trials networks: the 
HIV Vaccine Trials Network, HIV Prevention Trials Network, 
Infectious Diseases Clinical Research Consortium, and AIDS 
Clinical Trials Group.45

US DHHS, FDA CTAP Special emergency program for possible COVID-19 
therapies.46 Provides FDA subject matter expertise for ACTIV 
initiatives, including for clinical trial design/conduct and 
regulatory standards.

ACT, Access to COVID-19 Tools; ACTIV, Accelerating COVID-19 Therapeutic Interventions and Vaccines; AIDS, acquired immunodeficiency syndrome; BARDA, 
Biomedical Advanced Research and Development Authority; COVPN, COVID-19 Prevention Trials Network; CTAP, Coronavirus Treatment Acceleration Program; DHHS, 
Department of Health and Human Services; DoD, Department of Defense; FNIH, Foundation of the National Institutes of Health; HIV, human immunodeficiency virus; 
NIAID, National Institute of Allergy and Infectious Diseases; NIH, National Institutes of Health; OWS, Operation Warp Speed; RADx, Rapid Acceleration of Diagnostics.
aCOVAX is the vaccines pillar of the ACT Accelerator. More information on the nonvaccine pillars of the ACT Accelerator is available at https://www.who.int/initiatives/
act-accelerator. On December 31, 2020, the first vaccine received emergency use validation from WHO.39

bThe results of the Solidarity I adaptive treatment trial became available October 15, 2020, and concluded that the 4 treatments studied (remdesivir, 
hydroxychloroquine, lopinavir/ritonavir, and interferon) had little or no effect compared with standard of care on overall mortality, initiation of ventilation, and duration of 
hospital stay in hospitalized patients. Additional agents to be evaluated per WHO.

https://www.who.int/initiatives/act-accelerator


      AMWA Journal / V36 N2 / 2021 / amwa.org    67

Diagnostics and Medical Equipment for COVID-19 
Under EUA
In early February 2020, the first EUA for a reverse transcription 

polymerase chain reaction COVID-19 diagnostic was issued 

for use at CDC laboratories.15 Emergency use authorizations 

were also subsequently issued for equipment needed to pro-

tect health care workers and treat patients with COVID-19 as 

well as for additional diagnostics at non-CDC laboratories that 

would reduce the time to and accuracy of results, including 

home testing kits most recently.13,16

 The issuance of FDA guidance on diagnostic testing in May 

202016 enabled the subsequent availability of additional testing 

options (for example, rapid antigen testing).

 Upon availability of such testing options, medical writers 

began incorporating COVID-19 testing strategies into study 

protocols and amendments, with built-in flexibility in lan-

guage to allow for regional differences in testing availability or 

adoption of CDC recommendations—a critical step toward the 

restart of early-phase trials, which often have an in-residence 

component at the Phase 1 unit.

Preventive and Therapeutic Products, Including 
Vaccines, for COVID-19 Under EUA 

The writing of clinical trial protocols for COVID-19 studies 

began in the context of the burgeoning geographic footprint 

of the pandemic, with health care centers in some regions too 

overwhelmed by critically ill patients to contribute to research 

while simultaneously in dire need of experimental treatments, 

leading to an added layer of volatility in an already dynamic 

process. Accordingly, regulatory advice on the conduct of such 

studies developed over time. Medical writers worked in con-

cert with their cross-functional partners, regulators, and other 

stakeholders to overcome these challenges and produce proto-

cols for evaluation of a novel virus and to interpret and convey 

the results of those studies in record time. 

 The first EUA for a COVID-19 therapeutic was granted in 

March 2020 for antimalarial agents hydroxychloroquine and 

chloroquine (Table 2).13 The FDA issued several guidance 

documents in May 2020 toward expediting development of 

COVID-19 products,17 including information on the process 

for initiating discussions with the FDA (pre-IND)18 and study 

design recommendations, including patient selection, end-

points, and analyses.19,20 Guidelines on vaccine development 

were issued the following month and updated in October and 

most recently in February of 2021 to outline the vaccine EUA 

process.21,22 Subsequent EUAs were granted for 9 additional 

products, including an antiviral in May, convalescent plasma 

in August, monoclonal antibody regimens in November, and 

the first vaccines in December 2020 (Table 2).13,23 Monitoring 

of previously issued EUAs continues and, in some cases, has 

led to the withdrawal of the EUA, such as that which occurred 

for hydroxychloroquine and chloroquine upon analysis of con-

flicting data (including results from a randomized, controlled 

trial) that brought into question the benefit-risk profile of this 

regimen for treatment of COVID-19.13,24,25 The EUA issued for 

antiviral remdesivir in May led to approval of the drug as the 

first treatment for COVID-19 under the Coronavirus Treatment 

Acceleration Program (see Table 1) in October 2020. 

 As of January 2021, a search on the US National Library of 

Medicine’s Clinicaltrials.gov (search terms of COVID-19 and 

SARS-CoV-2, with a recruitment status of not yet recruiting, 

recruiting, enrolling by invitation, active, or not recruiting) 

returns results for over 3,500 COVID-19 clinical trials that are 

ongoing or in start-up.26

Clinical Trials During the COVID-19 Pandemic
Between approximately March and May 2020, thousands of 

clinical trials (or around 80% of non-COVID-19 trials) reported 

a disruption,27-30 with the majority of these being early-phase 

trials that had not yet started enrolling patients.27,29 The most 

affected therapeutic areas included those enrolling partici-

pants with advanced or life-threatening conditions such as 

cardiovascular disease or oncology—indeed, the very patients 

who are most at risk for COVID-1931—who often have few 

other treatment options; the typical intravenous administra-

tion route of oncologic treatments, which require patients to go 

to the clinical site for infusions, has led to additional logistical 

hurdles.29,32 Disruptions were reported as delay or suspension 

in enrollment, delay in study start-up activities or initiation 

of certain sites, delay in dosing, termination of enrollment at 

specific sites, early trial termination, and delay in trial comple-

tion or availability of data.26,29 In many cases, clinical trials that 

were nearly or already fully enrolled in patient populations 

with life-threatening conditions continued with modifications 

to address the uncertainties and challenges of conducting clin-

ical trials in an already burdened health care system.29 

 In March 2020, the FDA issued guidance on the conduct of 

clinical trials during the COVID-19 pandemic, with the goal of 

ensuring “the safety of trial participants, maintaining compli-

ance with good clinical practice and minimizing risks to trial 

integrity.”33 The guidance has been updated on a regular basis 

and covers key topics, such as:

• Electronic and other remote informed consent options

• Alternative formats for visits (eg, phone contact, virtual visit, 

alternative locations, local laboratory or imaging centers, 

home nursing)

• Alternative formats for clinical outcome assessments  

(ie, patient-reported outcomes, clinician-reported out-

comes, and observer-reported outcomes), including  

protection of data privacy



68    AMWA Journal / V36 N2 / 2021 / amwa.org        

Table 2. COVID-19 Therapeutics and Biological Products Approved Under EUA

Date of First EUA 
Issuance (Reissu-
ance, if Applicable)

Approved Product  
Under EUA Therapy Type Authorized Use

March 29, 2021 Janssen COVID-19 vaccine Recombinant, replication-
incompetent human Ad26 vectored 
vaccine encoding a stabilized 
variant of the SARS-CoV-2 S protein

For the prevention of COVID-19 for individuals 
≥18 years old

December 18, 2020
(Reissued February 
25, 2021)

Moderna COVID-19 vaccine mRNA vaccine For the prevention of COVID-19 for individuals 
≥18 years old

December 11, 2020
(Reissued February 
25, 2021)

Pfizer-BioNTech COVID-19  
vaccine

mRNA vaccine For the prevention of COVID-19 for individuals 
≥16 years old

February 09, 2021
(Reissued  
February 25, 2021)

Bamlanivimab and etesevimab Antibodies For the treatment of mild-to-moderate  
COVID-19 in adult and pediatric patients with 
positive results of direct SARS-CoV-2 viral 
testing who are ≥12 years old, weigh at least 
40 kg, and are at high risk for progressing to 
severe COVID-19 and/or hospitalization

November 21, 2020
(Reissued February 
25, 2021)

Casirivimab and imdevimab Antibodies For the treatment of mild-to-moderate  
COVID-19 in adults and pediatric patients 
(≥12 years old weighing ≥40 kg) with positive 
results of direct SARS-CoV-2 viral testing and 
who are at high risk for progressing to severe 
COVID-19 and/or hospitalization

November 19, 2020 Baricitinib in combination with 
remdesivir

Antibody + antiviral For emergency use by health care providers 
for the treatment of suspected or laboratory-
confirmed COVID-19 in hospitalized adults and 
pediatric patients ≥2 years of age requiring 
supplemental oxygen, invasive mechanical 
ventilation, or ECMO

August 23, 2020
(Reissued March 09, 
2021)

COVID-19 convalescent plasma Convalescent plasma For the treatment of hospitalized patients  
with COVID-19

August 13, 2020 Sodium chloride and
sodium citrate renal replace-
ment and regional solution for 
anticoagulation of the extracor-
poreal circuit

Replacement solution for 
CRRT

To be used as a replacement solution only 
in adult patients treated with CRRT, and for 
whom regional citrate anticoagulation is  
appropriate, in a critical care setting

May 8, 2020 Propofol 2% Sedative To maintain sedation via continuous infusion 
in patients >16 years old with suspected or 
confirmed COVID-19 who require mechanical 
ventilation in an ICU setting

May 1, 2020
(Reissued October 
22, 2020)a

Remdesivir for certain hospital-
ized patients with COVID-19

Antiviral For emergency use by licensed health care 
providers for the treatment of suspected or 
laboratory-confirmed COVID-19 in hospitalized 
pediatric patients weighing 3.5 kg to <40 kg or 
hospitalized pediatric patients <12 years old 
weighing at least 3.5 kg

April 30, 2020 Potassium-free and 2, 3, and 
4 mmol/L potassium solution for 
hemodialysis/hemofiltration

Replacement solution for 
CRRT

To provide CRRT to treat patients in an acute 
care environment during the COVID-19  
pandemic

Source: FDA 2021.13

Ad26, adenovirus serotype 26; CRRT, continuous renal replacement therapy; ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit; mRNA, messenger RNA.
aThe original EUA for remdesivir issued May 1, 2020, was for the treatment of suspected or laboratory-confirmed COVID-19 in adult and pediatric patients hospitalized with severe 
disease. The EUA was expanded to include adult and pediatric patients with COVID-19 irrespective of severity on August 28, 2020. Remdesivir was the first treatment to receive 
approval under Coronavirus Treatment Acceleration Program on October 22, 2020, for use in adults and pediatric patients with COVID-19 who are ≥12 years old and weigh ≥40 kg 
requiring hospitalization; the EUA was reissued to allow for continued access to a subset of hospitalized pediatric patients with suspected or laboratory-confirmed COVID-19 who 
weigh 3.5 kg to <40 kg or who are <12 years old and weigh at least 3.5 kg.



AMWA Journal / V36 N2 / 2021 / amwa.org    69

• Supply chain considerations, such as direct-to-patient 

shipping, administration by a home nurse, and disposal of 

the investigational product

• Remote site monitoring considerations, including prioritiza-

tion of monitoring activities in the circumstance of clinical 

trial site closures, infectious disease control restrictions, or 

local travel constraints

• Serious adverse event (SAE) reporting, including reporting 

of cases of COVID-19 on non-COVID-19 clinical trials and 

cross-reporting of SAEs in the case of multiple INDs

 A key takeaway of the guidance is to ensure collection of 

information on when and how any mitigations were imple-

mented in a clinical trial to facilitate subsequent reporting on 

the impact of COVID-19 on the trial objectives.

 In addition, the biotech and pharmaceutical industry has 

contributed to the discussion of clinical trial mitigations neces-

sitated by COVID-19. TransCelerate Biopharma, a collection 

of member biotech and pharmaceutical companies working 

to standardize key clinical trial activities, released a number 

of COVID-19–related initiatives, including a data-sharing plat-

form called DataCelerate for COVID-19 research, tools for risk-

based monitoring and protocol deviation management, and a 

clinical study report template for outlining details on COVID-

19–related clinical trial impact.34,35 With information changing 

regularly because of the dynamic nature of the pandemic and its 

regionally varied effects, and with ongoing updates from global 

health agencies, however, it is clear that any such tool will be a 

work in progress rather than a static guideline and that medical 

writers will need to stay informed on any updates over time.

 It is unclear as of yet what impact these mitigations have 

had on the overall continuation of non-COVID-19 clinical trials 

during the pandemic. The success of the mitigations will need 

to be analyzed and reported on at an individual study level, 

depending on the company’s assessment of what measures 

were needed at the time the pandemic affected the trial, with 

any publications based on the trial footnoted accordingly with 

this context. Based on regional variation on how the measures 

could be implemented, it is also possible that some mitigations 

will be successful in some regions but not others or that some 

mitigations were successful overall, whereas other planned 

mitigations were unsuccessful because of local circumstances. 

It is clear that properly contextualizing and reporting out the 

results of any such mitigations will be a time-consuming effort 

that requires complete source documentation and follow-up 

on details with CRO and site partners.

Looking Forward
For medical writers, the pandemic has provided both opportu-

nities, such as the opportunity to work on the surge of COVID-

19–related clinical study protocols and manuscripts, and 

challenges, such as the interruption of some non-COVID-19 

studies or research and the need to work with urgency to pro-

duce communication for various purposes.

 As we pass the 1-year mark from when the first cases of 

COVID-19 were reported, with the recent approval of vaccines, 

some aspects of the medical writing profession and the indus-

try in general may start to return to normal. Time will tell how 

biotech and pharmaceutical companies, which are reliant on 

raising capital for operational costs, will fare with the delay of 

important milestone reporting that helps raise those funds. 

Trials of preventive and therapeutic products for COVID-19 will 

continue, including those in nonhospitalized settings36 and in 

different age groups and populations; sequelae of COVID-19 

will also require treatment. Viral mutations and their implica-

tions on available treatments and vaccines will require moni-

toring,37 and new waves of lockdowns may cause continued 

clinical trial enrollment and execution challenges as certain 

regions with increased case counts return to lockdown. It 

remains to be determined how some of the efficiencies gained 

during the pandemic will be applied as learning for future pro-

cesses in a sustainable way.

Author declaration and disclosures: Jeanette Towles has received funds 
from several biotech and pharmaceutical companies for regulatory writ-
ing services on COVID-19 clinical trials.

Author contact: jtowles@synterex.com

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https://stacks.cdc.gov/view/cdc/99303
https://www.who.int/news/item/03-12-2020-global-access-to-covid-19-vaccines-estimated-to-generate-economic-benefits-of-at-least-153-billion-in-2020-21
https://www.who.int/news/item/03-12-2020-global-access-to-covid-19-vaccines-estimated-to-generate-economic-benefits-of-at-least-153-billion-in-2020-21
https://www.who.int/news/item/03-12-2020-global-access-to-covid-19-vaccines-estimated-to-generate-economic-benefits-of-at-least-153-billion-in-2020-21
https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access
https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access
https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access
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https://www.who.int/teams/blueprint/covid-19
https://www.who.int/publications/m/item/a-coordinated-global-research-roadmap
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations
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