Friday, July 12, 2013

On the ethics of randomized clinical trials (RCTs) in global health

In the Lancet's new global heath blog, Paul Farmer argues against the excesses of RCTs in the global health sector: 
This kind of study can only be carried out ethically if the intervention being assessed is in equipoise, meaning that the medical community is in genuine doubt about its clinical merits...
The world we inhabit, as researchers and clinicians and policy-makers and journal readers, is not in equipoise. It is one in which great disparities of risk for disease, and for unequal access to already proven preventions and remedies, are marked and often extreme. For example, it has been demonstrated in HaitiCambodia, and in settings across Africa, that, among patients with active tuberculosis and advanced HIV infection, even brief delays in the initiation of ART are associated with increased mortality. In fact, it has been shown in every study in which this question has been proposed and evaluated. It’s not clear that randomized, controlled trials are necessary to show this yet again, especially in settings in which HIV disease and tuberculosis are the ranking causes of young adult death. This is one of the reasons that the recent publication of one South African trial, which sought to compare outcomes with delayed ART to concurrent initiation of combination chemotherapy for both diseases, occasioned recrimination from some ethicists. 
Dr. Farmer's suggestion solution: 
So what then is the charge of a global health journal? First, to recognize that the information gleaned from a rigorous observational study may be more useful to programme implementation than information derived from what are now reified as clinical trials. In terms rarely used in research circles, such observational methods should be deemed pertinent to clinical trials of equity. When journals recognize this by publishing more such studies, research funding will likely follow, shifting funding to studies conceived to improve the delivery of prevention and care and to learning through the process of implementation. Second, journal editors can help ensure that results are presented in such a way that any study’s methods can be understood and assessed by implementers and by those setting and revising health policy regarding life-and-death matters, including those mentioned above and many others now emerging. Like Rwanda, these are settings of rapid change in both burdens of disease and in the tools available to address them. Finally, journal editors might favour, for review and publication, research that reflects meaningful involvement of the implementers and managers, as research generated in this manner is most likely to address the needs and constraints of health programmes in settings of poverty and high burdens of disease.

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