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Clinical Trials Q1 2021

Re-evaluating clinical trials to ensure their effective progress

iStock / Getty Images Plus / Maksim Tkachenko

Dr Janet Woodcock

Acting Commissioner, US Food and Drug Administration (FDA)

Strengthening clinical trial capabilities and infrastructure is key to yielding actionable data. 

The COVID-19 pandemic has posed challenges to the conduct of all clinical trials, including those for COVID-19. To advise investigators during the pandemic, the Food and Drug Administration (FDA) issued guidance on how best to adapt trials, including recommendations on the use of virtual visits and methods for secure delivery of medications.  

The agency also issued guidance to help expand the availability and capability of low-risk, non-invasive medical devices for remote patient monitoring. Updating policies and utilising available technology have been key to making sure trials can continue. 

Assessing global clinical trial data 

Specific to the intense efforts to find effective therapies for COVID-19, our scientists recently conducted an assessment of clinical development efforts worldwide, focusing on data from ongoing interventional clinical trials.  

The most important finding was that the vast majority of global trials of therapeutics for COVID-19 are not designed to yield actionable information—low randomisation rates and lack of adequate statistical power render the results suggestive at best. Notably, there was great duplication of effort among registered trial arms, with multiple small trials studying similar interventions in similar populations. In addition, despite the millions of patients infected, enrolment was often slow, as trials could generally be set up only at traditional sites. 

All stakeholders must participate in a re-evaluation of how clinical evidence generation is carried out.

Re-evaluating clinical evidence  

These findings should raise general concern about the response of the clinical trial enterprise to the pandemic. All stakeholders must participate in a re-evaluation of how clinical evidence generation is carried out, both for trials of common conditions and for public health emergencies. This evaluation must include finding ways to enhance inclusiveness, enrol participants closer to home, with providers they know and trust, and position the clinical development infrastructure for the future. 

The U.S. Food and Drug Administration has long been focused on improving the design and conduct of clinical trials, as well as advancing additional data sources to improve the evaluation of medical products. The agency’s work with medical product developers includes efforts to better standardise data collection and expand patient access to trials.  

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