Almost a month ago, I told you about a pair of new case studies released by The Global Campaign for Microbicides which examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of antiretrovirals in preventing HIV infection were halted. In that post, I also proposed that we read and discuss these case studies as a sort of ethics book club.
Next Monday, June 15, we’ll be kicking off our discussion of the first case study, “Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site” (PDF).
The case study is on the long side (54 pages), but it is packed with really fascinating information that sheds light on the many challenges for international teams trying to conduct ethical and scientifically sound clinical trials at sites in different countries. My hope is that in discussing the various ways things went wrong in the Cameroon study, we can draw some lessons about how to make future trials go right.
Here are some of the broad questions I think may be worth discussing when we look at this case:
- Are you surprised at who viewed themselves as interested parties in this clinical trial? How did various of these parties understand (or misunderstand) each other’s interests? Their own interests?
- How well did various parties’ strategies suit the interests they were pursuing?
- To what extent might better information (especially about the interests and strategies of other interested parties) have changed the goals the various parties were pursuing and the strategies they used to pursue them?
- If conducting ethical clinical trials is a serious goal, are there changes that should be made in the ways research is approved and funded?
- If conducting ethical clinical trials is a serious goal, who ought to bear the costs involved?
- What is the deal with the media anyway?
This case has something for everyone — big scientific collaborations, a pharmaceutical company, a non-profit sponsor, a vulnerable study population, activists, government officials, sensationalistic media, and communications breakdowns.
Read it, think about it, and come back next week to discuss it with us.