Two new case studies on international clinical trials (and a plan to read them together).

Earlier this week, I found out about a pair of new case studies being released by The Global Campaign for Microbicides. These cases examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of microbicides antiretrovirals in preventing HIV infection were halted. Here are some details:

Between August 2004 and February 2005 the HIV prevention world was rocked by the suspension and cancellation of PrEP effectiveness trials in Cambodia and Cameroon. To the considerable surprise of researchers, advocates, and donors, the trials became embroiled in escalating controversies and sparked protests by advocates speaking on behalf of the communities where trial participants were being recruited. The activists not only raised questions about how the research was being conducted, but also challenged the fundamental ethics and underlying motives of the research.

The Global Campaign for Microbicides is launching two in-depth case studies relating the events that led to these cancellations and extracting the lessons they provide for current and future research. Acknowledging that no single version of the events constitutes the "real story", the case studies are built from extensive interviews with researchers, policymakers and other government officials, donors, NGO staff, and advocates to reconstruct often incompatible accounts of what eventually led to government intervention that halted the research. The case studies capture the political context and backdrop against which the controversies arose and the underlying and unaddressed conflicts that led to the costly collapse of two Phase 3 trials.

These reports are important and exciting reading for anyone interested in sound science, human rights and communication across enormous cultural, social, and economic disparities. The HIV prevention field has made substantial progress since 2005 in forging mechanisms to be transparent and build trust between trial communities and researchers. But much remains to be done, and that the potential for conflict remains.

As the first PrEP trials move toward completion this year, these case studies offer a timely look at what we have learned and what pressing challenges remain unaddressed.

As detailed as the two cases are, they are also long:

Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site (PDF) -- 54 pages
by Elizabeth McGrory, Andrea Irvin and Lori Heise

Preventing Prevention Trial Failures: A Case Study and Lessons for Future Trials from the 2004 Tenofovir Trial in Cambodia (PDF) -- 36 pages
by Anna Forbes and Sanushka Muldaliar

Given the length, I had an idea:

Let's read and discuss these case studies as a sort of ethics book club. The PDFs are free to download, and knowing you wonderful commenters as I do, I can't imagine a better group of people with whom to dig into the details. (I'll also see what I can do about enticing some other bloggers to participate -- perhaps someone who focuses on infectious diseases, or public health, or pharmacology, or medicine more broadly.)

If you are game, I propose that we kick off discussion of Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site one month from today, on June 15. (This will give you plenty of time to getting around to reading it.) Then, we can shoot for starting our discussion of Preventing Prevention Trial Failures: A Case Study and Lessons for Future Trials from the 2004 Tenofovir Trial in Cambodia on July 15.

I shall bring the virtual tea and cookies for our discussions.