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https://doi.org/10.47488/dhrp.v2iS1.41 

 
http://dhrproceedings.org 4 © DHR Health Institute for Research and Development 

 

COMMENTARY 

Challenges and Opportunities in Conducting 
Translational and Clinical Research in 
Academic Institutions and Universities 
Sohail Rao, MD, MA, DPhil1, 2  

 1Executive Vice President, DHR Health, 5501 S. McColl Road, Edinburg, Texas 78539 and President 
& Chief Executive Officer, DHR Health Institute for Research & Development, 5323 S. McColl Road, 
Edinburg, Texas 78539.  
ORCID: https://orcid.org/0000-0001-5027-9992  
2 Correspondence should be addressed to: Sohail Rao, MD, MA, DPhil., DHR Health Institute for 
Research & Development, 5323 S. McColl Road, Edinburg, Texas 78539. Tel: (956) 362-2387. E-mail: 
s.rao@dhr-rgv.com  
 
Received 03/01/2022 
Accepted for publication 03/01/2022 
Published 03/01/2022 

Keywords:  Clinical Research; Translational Research; Independent Research Centers

The global clinical trials market size was estimated at USD 
44.3 billion in 2020 and is expected to expand at a compound 
annual growth rate of 5.7% from 2021 to 2028. However, the 
market growth was hindered in 2020 due to the COVID-19 
pandemic. Nevertheless, the future seems promising for the 
market owing to factors such as globalization of clinical 
trials, rapid technological evolution, and augmenting demand 
for clinical research organizations to conduct research 
activities. The increasing prevalence of chronic disease and 
the growing demand for clinical trials in developing 
countries are also fueling this market’s growth. The market is 
also driven by a rising number of biologics, the need for 
personalized medicines and orphan drugs, and demand for 
advanced technologies. 

Cooperation among a diverse group of stakeholders—
including research sponsors (industry, academia, 
government, nonprofit organizations, clinical research 
organizations, and patient advocates), clinical investigators, 
patients, payers, physicians, and regulators—is necessary in 
conducting a clinical trial today. Each stakeholder offers a 
different set of tools to support the essential components of a 
clinical trial. These resources form the infrastructure that 
currently supports clinical research in the United States. 
Time, money, personnel, materials (e.g., medical supplies), 
support systems (informatics as well as manpower), and a 
clear plan for completing the necessary steps in a trial are all 
part of the clinical research infrastructure. Most clinical trials 

are conducted in a “one-off” manner in which the necessary 
components of a trial (usually a single coordinating center 
and multiple research sites) are brought together for a 
discrete period of time and disbanded once the trial is 
completed. 

It is interesting to note that fewer than half of all the medical 
treatments delivered today are supported by evidence and yet 
the United States lacks a clear prioritization of the gaps in 
medical evidence and allocation of clinical research 
resources to fill these evidence gaps efficiently and 
effectively (1). The federal government, industry, academic 
institutions, patient advocacy organizations, voluntary health 
organizations, and payers each have incentives to develop 
research questions that suit their unique interests. The value 
of a particular research effort is judged by stakeholders 
according to their own cost–benefit calculation. Reflecting 
the diversity of stakeholder value judgments, and in the 
absence of a broad national agenda, clinical trials are 
conducted in a “one-off,” narrowly focused fashion. 

Because clinical trials are necessary to obtain regulatory 
approval in the United States, they are a high priority to 
companies. Therefore, prioritization of clinical research 
questions by companies seeking regulatory approval is 
distinctly different from the priorities of society in general, 
which may prioritize the comparison of two commonly used 
therapies. This divergence between the priorities of society 

https://orcid.org/0000-0001-5027-9992
mailto:s.rao@dhr-rgv.com


DHRP, 2022, Vol. 2 (S1) 4-6  Clinical Research in Academic Institutions 

 
http://dhrproceedings.org 5 © DHR Health Institute for Research and Development 
 

and industry is notable as the nation discusses how to address 
the current gaps in clinical research and medical decision 
making. 

 Significant time, energy, and money are spent on bringing 
the disparate resources for each trial together. It is therefore 
reasonable to argue that efficiencies could be gained by 
streamlining the clinical trials infrastructure so that those 
investigating new research questions could quickly draw on 
resources already in place instead of reinventing the wheel 
for each trial. The process for obtaining US Food and Drug 
Administration approval for a drug and/or a biological agent 
is extremely protracted and cumbrous. On an average, it 
takes 10-17 years for a drug to be approved for use in 
humans costing in most instances millions of dollars to the 
biopharmaceutical industry (Figure 1). Therefore, it is 
imperative that entities involved in clinical research focus 
on managing the time to recruitment of the first patient 
in each trial an outcome that can only be accomplished 
by having a streamlined process (Table 1). They must 
also ensure that the data is of the highest quality and 
available to the sponsors in a timely manner and that the 
research subjects screened and/or accrued in each clinical 
trial must meet the inclusion and exclusion criteria 
outlined in the protocol. 

Figure 1: Time to Completion of Various Phases of Clinical Trials 
and the Number of Biological Molecules Tested to Yield one (1) 
FDA-approved Drug 

In the past, clinical research was performed primarily at 
major academic centers and universities. However, today 
most clinical research is performed in independent research 
centers and private clinics throughout the country.  Many of 
the changes were brought on by rising costs in health care 
and the growing bureaucracies in academic institutions that 
have made initiating clinical research an onerous task in 
these entities.  

The practice of evidence-based medicine is at the core of 
providing quality and innovative clinical care and to 
accomplish this objective, it is quintessential for any 
organization involved in patient care to conduct translational 
and clinical research.  Therefore, if academic institutions 

and universities who are involved in clinical care, are 
serious about regaining their share of translational and 
clinical research, they must undergo a transformational 
change and adopt a more streamlined process for 
initiating trials in their facilities and work towards 
eliminating the unnecessary burden of administrative 
bureaucracy that has resulted in this outcome.  

Table 1: Critical Components of a Streamlined Review, Approval, 
and Implementation Process for a Successful Clinical Research 
Trial 
 

REGULATORY • Succinct Policies & 
Guidelines 

• Patient-centered Institution 
Review Board (IRB) 

OPERATIONS • Master Affiliation 
Agreements with Sponsors 

• Budgets and Contracts 
• Confidentiality/Non-

disclosure Agreements 

TECHNOLOGY • Feasibility Studies 
• Electronic Data Capture 

Application 
• User-friendly Electronic 

Medical Record 
• Investigator-friendly 

Electronic IRB Submission 
Software 

PERSONNEL • Physician Investigator 
• Advanced Practice Nurse (if 

required) 
• Experience Clinical Research 

Coordinator 
• Support Staff (Medical 

assistants, Phlebotomist, Data 
Managers, etc) 

• Research Information 
Technologists 

INFRASTRUCTURE • Adequate space, Equipment, 
and Supplies 

It is our recommendation that for academic institutions and 
universities to be successful in conducting translational and 
clinical research, they must seriously consider establishing an 
independent nonprofit research institute that is tasked with 
the responsibility of managing the entire process and have all 
the critical components under one roof that are outlined in 



DHRP, 2022, Vol. 2 (S1) 4-6  Clinical Research in Academic Institutions 

 
http://dhrproceedings.org 6 © DHR Health Institute for Research and Development 

Table 1. This would be in the best interest of the academic 
institutions and the universities as it would isolate the 
inherent risk and liability associated with the conduct of 
clinical trials. Lastly, the person assigned to lead this process 
must be a visionary who is a seasoned clinical investigator 
and research administrator with documented experience and 
expertise in establishing and managing such entities.    

Diclosures 

SR declares no conflicts of interest.  

Funding 

The project is funded by a Seed Grant from the DHR Health 
Institute for Research & Development 

References 

1. Institute of Medicine (US) Roundtable on Evidence-
Based Medicine. The Healthcare Imperative: 
Lowering Costs and Improving Outcomes: 
Workshop Series Summary. Yong PL, Saunders RS, 
Olsen L, editors. Washington (DC): National 
Academies Press (US); 2010. PMID: 21595114.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


