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Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

Clinical trial disclosure has received much international attention. The US Congress has enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA), also known as Public Law 110-85. Section 801 of FDAAA requires public registration of new or ongoing clinical trials and disclosure of results for completed clinical trials on the public database ClinicalTrials.gov. FDAAA has provisions for proof of compliance and authorizes penalties for noncompliance; several phases will be implemented over 3 years and completed by 2010. In the European Union (EU), the European Parliament enacted the Clinical Trials Directive (Directive 2001/20/EC of April 4, 2001), which governs public access to information on clinical trials in the European Community. Article 11 of the Clinical Trials Directive, enforced by the European Medicines Agency (EMEA), deals with the exchange of information among the EU member states. In some cases, it also deals with the countries of the European Economic Area. The directive is accompanied by two regulations; one refers to clinical trials in general, and the other applies specifically to trials in the pediatric population. These regulations describe how some of the protocol and results information in the EudraCT database at EMEA will be automatically released to the public through the EudraPharm database. The public release is planned for 2010 and 2011. Requirements for clinical trials disclosure have also been established at the national level in several countries. A summary is presented here of the key global requirements for public disclosure of clinical trial information on drugs, biologics, and medical devices, with a brief overview on the position of various stakeholders involved in this important and evolving topic.