People often enter drug studies in order to access a promising new drug. But clinical trials take place over a set time period. So is it ethical to withhold from prospective trial subjects preliminary data on safety or efficacy that have been gathered from initial volunteers? In the Feb 1, 2008 issue of Journal of Clinical Oncology, Robert Wells argues it isn't. Biostatistician Steven Piantadosi, in a rebuttal, argues that it is.
Wells argues (I paraphrase) that anything short of total transparency frustrates patient autonomy and breaches scientific and clinical duties. Piantadosi offers two counter-arguments: first, there are no obligations to disclose uninterpretable data, and second, in research, clinical obligations for full disclosure do not "supercede" societal interests in safeguarding the integrity of data.
The debate revolves around the tension between clinical research (which is primarily aimed at serving society) and clinical care (aimed at serving individual patients). Though I agree that the withholding of preliminary data should make us uncomfortable, total transparency in clinical research would necessitate abandoning well established practices– like blinding and placebo use– that maximize the reliability of knowledge gleaned from clinical trials. The key to navigating the ethical tension lies in making sure volunteers recognize that trials are aimed primarily at serving society. (photo credit: Kah Zanon, 2007)