Coronavirus drugs trials must get bigger and more collaborative
14 May, 2020
The pandemic has given rise to too many small and uncontrolled clinical trials.
Researchers have rallied in unprecedented ways to defeat the coronavirus pandemic. They are retooling laboratories to focus on the virus; helping with testing efforts; and, in the case of clinician–researchers, working feverishly to carry out research studies while also treating patients in overwhelmed health-care systems.
Some clinical trials — such as the World Health Organization’s Solidarity trial of four potential COVID-19 therapies — are large and collaborative. They involve teams working together across many sites to test drug candidates against COVID-19. However, in the urgency to find treatments, other trials are smaller, do not always include a control group and don’t test medicines on enough patients to provide statistically meaningful results.
Studies of the experimental antiviral drug remdesivir provide an example of the clinical chaos that can ensue when trials are not well designed. Remdesivir is widely considered to be among the best candidates for a drug against SARS-CoV-2, the virus that causes COVID-19. Over the past four months, a series of studies have been launched to investigate remdesivir’s effectiveness against COVID-19, but they have produced conflicting results.
A pandemic emergency is a reason to work faster, but researchers must not lose sight of the fact that experimental interventions carry an inherent risk to the patient. To balance this risk, clinical trials must be as robustly designed as possible. Some trials need to be small, initial explorations of potential treatments; but, after that, researchers must think big. It’s important to move quickly to larger, collaborative trials — ones that span borders and share expertise — that have a greater chance of showing what really works.