Several research sponsors have questioned the appropriate process for making changes to clinical studies in response to the current COVID-19 epidemic. This article provides the FDA requirements for IRB review of changes in research made in response to COVID-19.
Infectious disease "challenge" studies are ones in which healthy participants are intentionally infected with pathogens in order to investigate the cause, prevention, and treatment of infectious diseases — but are they ethical? These studies, while useful, pose ethical concerns, and numerous criteria must be met for an infectious challenge to be ethically permissible.
As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.
New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective: Are payments to participants actually too low? This article explores this question and whether we should, in fact, worry much less about restricting compensation for research participants.
Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants. Learn about the current best practices for the content and preparation of plain language summaries and the current guidance for how sponsors should work with institutional review boards (IRBs), which have oversight of the clinical trials for which the summaries are provided.