EU Clinical Trials Regulation

摘要

Yet, the revision of the Clinical Trials Regulation offers a major opportunity to redirect clinical research and development towards a model that meets real public health needs, by: (1) requiring comparative clinical trials in accordance with the Declaration of Helsinki which specifies that "The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention", and warns against the use of placebo-controlled clinical trials, stating that "extreme care must be taken to avoid abuse of this option"; (2) granting public access to raw data and clinical study reports, which would allow independent analysis and early detection of safety problems; (3) discouraging the conduct of unethical trials in countries outside the EU by demanding that clinical data submitted in the Common Technical Document (when applying for a medicine's marketing authorisation) is obtained from registered clinical trials that duly comply with the provisions of the new regulation; and (4) enacting and enforcing effective monitoring of clinical trials, to prevent any omission and data withholding.