COVID-19 Clinical Trials: Improving Research Infrastructure and Relevance

The COVID-19 pandemic is frequently cited as an event that will permanently change the way we do many things, such as educate, work, and provide medical care. According to authors from the Perelman School of Medicine, University of Pennsylvania, it also affords an opportunity to rethink the way clinical research is conducted. The authors provide recent examples of how coordinated efforts may benefit research into COVID-19.

As the Kimmel, et al. (2020) observe, "The need for a more robust, global clinical research infrastructure has been the subject of much effort during the past several decades. Despite recent progress, our research enterprise remains sometimes misguided and always inefficient. Many clinical questions are partially addressed through multiple small randomized trials designed to measure only biomarkers or putative surrogate end points. Small trials may be quicker to plan and complete, but inadequate statistical power can lead to false claims of failure or implausibly large effects when significant. Multiple small trials testing the same hypothesis increase the chance of false-positive results, leading to dissemination of false claims of benefit and jeopardizing the continuation of ongoing trials. Multiple protocols enrolling at the same institution can compete for participants with the same diagnosis. The net global effect of preferential recruitment into small, non-definitive trials slows recruitment into critical trials that could provide reliable evidence. Heterogeneity in treatment effects is also difficult to identify from small studies, particularly of homogeneous populations. The alternative approach of doing larger-scale, multi-center trials is notoriously difficult, particularly in the manner that is commonly used. Variations in institutions' approaches to consent documents, data sharing policies, and contract negotiations slow down the launch of many clinical trials. Participant recruitment and data collection are time-consuming and often unnecessarily resource-intensive. The perceived risk of human experimentation relative to the benefit to society is often a barrier to enrolling study participants."

They add, "Great strides have been made in formulating possible solutions to these deficiencies. These include the use of master or core protocols to more efficiently test multiple therapeutics across many sites and diseases, use of existing networks of institutions to streamline large-scale trials, better stakeholder input (including patients) into trial design to ensure relevance of study outcomes, reduced barriers to recruitment (for example, remote informed consent), and more cost-effective follow-up (for example, use of electronic health records). However, actual improvement has been slow. We believe that one of the main reasons is the dearth of 'teachable moments' or disruptive events that force change in a system with substantial aversion to innovation in normal times. The COVID-19 pandemic is such a moment. The research landscape around COVID-19 has served as a magnifying glass on the problems noted earlier, with the cost of inefficiencies—in terms of delayed answers and continued deaths—being brought into sharper focus than with perhaps any past disease."

Reference: Kimmel SE, et al. COVID-19 Clinical Trials: A Teachable Moment for Improving Our Research Infrastructure and Relevance. Ann Intern Med. June 16, 2020.

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