In collaboration with First Clinical Research, each month we share 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 the principal investigator/owner at an independent clinical research site that is struggling financially. The first person you enrolled in a cardiology study had a serious stroke after one week in the study. The person had no history of strokes or related conditions. After unblinding, your SAE report to the very large CRO identified the study drug as causation. After a heated discussion, the CRO’s medical monitor says he will “overrule” your conclusion and report the SAE (on your behalf) to the IRB and FDA with unknown causation. To prevent further issues, the study will be closed at your site.
Should you tell somebody about the situation? You have no other information to make your decision and no clever way to dodge it. Read the full question and give us your answer.
Last month's question required you to choose a new IRB member from six qualified people. The "Community Leader" was the most popular choice, for the following reasons:
- Should be well-versed on community demographics, cultures, perspectives and priorities.
- Is likely loyal to the segment of the community he or she leads.
- Is likely to have a wide network of contacts from which to obtain input.
- Could help the community learn about clinical research.
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!
Absolutely it should be reported to someone else. When reported to the IRB, the process is that an SAE (life threatening in this case) within 30 days of receiving an investigational product is a reportable event to the FDA/OHRP. The investigator is obligated to report his/her assessment of the event and the causality (not just to the sponsor). There should be a firm statement that this was discussed and reported per written documentation to the sponsor/CRO. The MM/CRO did not agree with the assessment/causality determination and was going to submit the report for the investigator. Source documentation should be attached to the investigator’s report to the federal agencies. The IRB/HSPPO will follow their process as well since a death that is determined to be caused by an IP, is a reportable event. This is manipulation of data by the MM/CRO and quite unethical. If they want to punish the site and close the study at the site so be it. If I was the PI I would not want to be associated with a MM/CRO/sponsor anyway. The multiple varying reports for the event and death will probably spark at least an FDA audit of this study and maybe other studies conducted by this CRO. The MM/CRO is working on the behalf of a pharmaceutical company then the report should be also forwarded to the pharmaceutical company’s Safety Surveillance Committee.
I inadvertently half way down referred to this as a death and it should have been an event