COVID-19: Pitfalls in Offering Research Participation as Therapy in Clinical Settings

Excerpt

As the coronavirus disease-19 (COVID-19) pandemic rages on through its seventh month, the USA bears the largest burden of the over 15 million cases worldwide.¹ Events of an epidemic unfold through progressive revelation, to managing randomness, and finally negotiating a public response.² In the earlier phases of the pandemic, clinicians were venturing to treat COVID-19 patients with therapies of unproven efficacy based on data from poorly conducted clinical trials and observational and anecdotal data. With limited peer-reviewed prospective data on therapies with mortality benefit, guidelines published since by societies have chosen to rein in the randomness by not recommending specific antiviral or immune-based therapy outside the setting of a clinical trial. Offering research participation as therapy represents a disadvantage for communities or populations who may have limited access to clinical trials or not be suited to participate in clinical trials. …