Funded by the European Union through the Erasmus and Jean Monnet program, the 2020 Summer School Improving Clinical Trial Data Transparency: Comparative Perspectives on Context, Challenges and Opportunities is organized by the Jean Monnet Health Law and Policy Network.
Clinical trial data transparency is certainly one of the most important and complex regulatory challenge in health care. Such transparency, and the details of its implementation, determines how much medical knowledge is shaped based on best available evidence or on a biased selection of evidence to better serve commercial interests. The issue of clinical trial transparency has been shown to be best a core struggle to improve medical practices and improve the lives of patients. Recent evolution with the establishment of clinicaltrials.gov, the regulatory changes at the European Medicines Agency and at Health Canada has significantly improved clinical trial data transparency, but the struggle is far from over and entails significant challenges.
In the face of rapid technological and social change, the role of regulatory agencies has become increasingly important in ensuring effective regulation of pharmaceuticals. The Food and Drug Administration (FDA), which originated following the passing of the ‘Pure Foods and Drug Act’ in 1906, stands as the oldest comprehensive consumer protection agency in the American federal government. Founded in 1995, the European Medicines Agency (EMA) commands a global presence in the protection of public and animal health. The EMA was originally a mediating body for other national regulatory agencies and its role has evolved in providing its partners, European scientific experts, and other stakeholders with independent, evidence-based expertise and information on the regulation of medicines. Health Canada, founded originally as the Department of Health in 1919, oversees the Canadian federal government’s jurisdiction of health care. Primarily responsible for ensuring the public health of Canadians, Health Canada plays a vital role in ensuring the safety of various health products, food, and pharmaceuticals. Health has established in 2019 the first portal providing full access to clinical trial data submitted to obtain drug approval.
Despite the efforts of these three regulatory agencies, there still exist various challenges in ensuring clinical trial data transparency and effective regulation of pharmaceutical product development. These challenges include conflicts of interest among public and private stakeholders, the legal frameworks and incentives that shape current practices, the changing regulatory and social context, and academic resistance to transparency. Discussions regarding these challenges will be held throughout the Summer School, many of which will be led by an interdisciplinary team of presenters and experts. Further, the program will offer engaging opportunities to discuss strategies to overcome these challenges, and to explore potential areas of reform.