Drug trials and evidence bases in international regulatory context

The complex ways in which technical challenges of trial design provoke, and are provoked by, ethical, commercial and political factors are considered. It is suggested that the quality of the drug trial evidence base greatly depends on the how ethical, commercial and political priorities are set, and not merely on standardized techniques of data processing. Whether such standardized techniques are raising or lowering the quality of safety information about new drugs, and the protection of patients on clinical trials is explored. It is revealed that these international standards, intended to define valid evidence-based medicine for drug trials, are not themselves robustly evidence-based. It is argued that the internationalized regulatory standards developed to frame the evidence base for drug safety and efficacy are frequently inconsistent with furthering patients¿ well-being and public health. Rather, those standards reflect a regulatory culture of neoliberal corporate bias, and have been powerfully shaped by the commercial and political interests of the pharmaceutical industry and regulatory institutions. It is questionable that regulatory agencies are thoroughly and robustly scrutinizing the claims that pharmaceutical firms make about their products. New political and regulatory arrangements that could facilitate more ethical drug trials in the interests of patients and public health are proposed.