Abstract
We illustrate and discuss the problems on the ethical implication of dissemination and disclosure of medical research data by using three examples. For investigating the efficacy of new drugs or treatments, clinical trials are usually required and the question rises regarding the policy of the timing and the form of disclosing the intermediate results. We illustrate this problem by introducing the Physicians' Health Study whose intermediate result was published in news papers before the publication in academic journals, thereby causing much controversy. Many studies with the same objectives are carried out all over the world, and those results may contradict one another. Meta-analysis is proposed for summarizing those results and widely used in cardiovascular and oncology area. In carrying out meta-analysis, there rises the problem of publication bias, i.e., papers with statistically significant results preferring new treatments are relatively easily published. As the second example, the problem of publication bias and the registration system of clinical trials for avoiding it are discussed. Development of anti-AIDS drugs is changing the traditional system of research and approval process for its seriousness and urgency. In the third example, an approval process of one anti-AIDS drug is discussed with special reference to methodology of clinical trials.
