Beyond Trial Registration: A Global Trial Bank for Clinical Trial Reporting

PLoS Medicine: Beyond Trial Registration: A Global Trial Bank for Clinical Trial Reporting: "A clinical trial is a research study in which human volunteers are treated and observed to an-swer a particular biomedical question. Clinical trials are one of the most valuable sources of evidence to determine which therapies are safe and effective. However, instances of selective re-porting of results to benefit proprietary interests rather than public health have recently come to light. For example, in 2004, GlaxoSmithKline settled a US$2.5 million lawsuit for suppressing trial results showing that its antidepressant paroxetine (Paxil) increased suicidal ideation in children [1]. More re-cently, Merck and Pfizer have been criticized for with-holding results showing increased risk of heart disease from COX-2 drugs such as rofecoxib (Vioxx) [2�4], which was withdrawn from the market because of these risks.
A complete public register of trials and the subsequent release of all results are crucially impor-tant to prevent drug and device makers from skewing the public record on the effectiveness of therapies. However, even when local laws require that trials be registered, compliance has been incomplete. In the United States, the Food and Drug Administration Modernization Act [5] requires that all trials on life-threatening diseases be registered into ClinicalTrials.gov (a register maintained by the National Institutes of Health), yet only 48% of industry-sponsored trials were registered during the initial period of the law's implementation [6]. Moreover, trials are sometimes registered with uninformative data (e.g., not giving the name of the tested drug) [7], thus subverting the central purpose of registration, which is to increase transparency."/.../