Even in the midst of a global pandemic, taking the time to conduct randomized controlled trials is the most rigorous way to build evidence for potential treatments, according to a recent opinion piece to which DCRI’s Executive Director contributed.
A recent Viewpoint piece in JAMA warns against drawing conclusions about the efficacy of treatments based only on observational studies—a phenomenon that is especially likely to occur during the COVID-19 pandemic when answers are needed quickly.
The piece, titled “Weighing the Benefits and Risks of Proliferating Observational Treatment Assessments: Observational Cacophony, Randomized Harmony,” outlines the risks of relying too heavily on observational studies, which are subject to bias and do not produce evidence with the same level of rigor as randomized clinical trials. DCRI’s Executive Director Adrian Hernandez, MD, MHS, (pictured left) is a co-author of the piece, along with former DCRI Executive Director and former FDA Commissioner Robert Califf, MD, who is now with Verily Life Sciences, and the University of Oxford’s Martin Landray, MB, ChB, FRCP. Both Hernandez and Landray are leading randomized controlled trials that are assessing the effectiveness of potential COVID-19 therapies.
Although great strides have been made in improving observational study methodology, thanks in part to work funded by the FDA and the NIH, randomized controlled trials remain the best method for developing rigorous evidence, the authors write. Improvements in the observational study infrastructure should “accelerate and prioritize the development and delivery of randomized trials, not be viewed as a substitute for them.”
Because of the rush to find a cure for COVID-19, inconclusive observational results have been widely reported by both lay and scientific press, sending mixed messages and contributing to the halting of some clinical trials. The authors warn that this over-reliance on observational studies could hinder the goal of finding treatments not only for COVID-19, but for other diseases as well.
The Viewpoint authors envision a world in which both forms of research make positive contributions to the landscape, with clinical trials finding evidence-based treatments, while observational data supporting ongoing learning as these treatments are administered to patients.