In collaboration with First Clinical Research, each month we feature a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.
This month’s question:
You are a principal investigator in a very promising Phase 3 pancreatic cancer study. The sponsor has just informed you that you can enroll only one more patient before enrollment closes. Enrolling in this study might save your patient’s life. Ten of your patients are eligible for the study. One is a young child; one is a well-respected physician; one is your mother-in law; one has a family to support; one is a convicted felon; one has been the victim of racial discrimination; etc.
Who do you invite to participate in the study, and how do you decide? Read the full question and give us your answer
April’s Question of the Month asked when citizen science qualifies as research. The survey respondents were nearly evenly divided about whether the scenario, which entailed a large group of citizens self-organizing to determine the efficacy of the drug, qualified as clinical research. From the discussion section of the results:
"Can the FDA intervene to protect the health of the participants? Probably not, since FDA does not regulate the practice of medicine, the participants are obtaining prescriptions for the drug from their physicians, and physicians have the right to prescribe drugs for off-label use.
Several respondents raised the issue of personal liberty. They noted that neither the FDA nor IRBs have the authority to tell patients how to conduct their personal affairs."
The Question of the Month also appears on the IRB Forum. The IRB Forum is a robust community of IRB professionals engaged in an ongoing discussion of the latest issues and questions that arise for human subjects protections professionals. An account is free, and gives you access to an invaluable resource—the insight of your peers.
PRIM&R thanks Norm Goldfarb of First Clinical Research for allowing us to share this feature with our community!