TAG ARCHIVES FOR Question of the Month

15
Sep2017

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? Read more

16
Aug2017

You are the director of human research protection at a community hospital. You have one IRB with seven members. Six of the members are physicians with staff privileges at your hospital. The seventh member, a representative from the community, just resigned from the IRB. Six qualified people have applied to fill the empty seat: a bioethicist, a minister, a former study participant, a community leader, a sociologist, and a member of a disadvantaged group served by the hospital. Because of a hospital policy that is set in stone, you can accept only one new IRB member. Read more

8
Jun2017

For this month’s question you are a member of a local IRB reviewing an influenza vaccine study. The investigator wants to ask enrolled study participants to help recruit additional study participants. The investigator wants to express her gratitude for this assistance. She has asked the IRB whether tangible expressions of gratitude, e.g., cash, would be acceptable. Read more

16
May2017

For 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. Who do you invite to participate in the study, and how do you decide? Read more

14
Apr2017

This month’s question places you in the FDA commissioner’s seat: You are the Commissioner of the FDA. A friend has informed you of the following situation: Over 1,000 people with severe, refractive emphysema have banded together to test a drug that is approved for asthma but not emphysema. Participants “drew straws” to determine which of them would ask their physicians for a prescription. While the FDA has no authority over the practice of medicine, it does have authority over clinical studies that create generalizable knowledge. Read more