Novartis Release: Industry Group Supports Uniform Approach to Transparency of Clinical Trial Data
NEW YORK, April 5, 2013 /PRNewswire/ -- As part of an ongoing industry-wide commitment to ensuring transparency in clinical studies, a group of pharmaceutical and biotechnology companies*, including AbbVie, AstraZeneca Pharmaceuticals LP, BiogenIdec, Bristol-Myers Squibb, EMD Serono, GlaxoSmithKline, Janssen, the Pharmaceutical Companies of Johnson & Johnson, Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk A/S, Roche, and Takeda Pharmaceuticals International, Inc., congratulates the Institute of Medicine (IOM) for their leadership in planning a consensus study later this year on the topic of sharing clinical trial data. The study will focus on making recommendations for responsibly sharing clinical trial data. Input will be drawn from a broad range of stakeholders, including academic institutions, private industry, patient advocacy, non-profit organizations, medical journals, health care providers, government, and international regulatory agencies.
The IOM applies a rigorous research process to develop objective and straightforward answers to difficult questions of national and international importance. Independence and objectivity are hallmarks of the IOM study process. While the statement of task for a study is developed in collaboration with sponsors, the study committee works independently to reach consensus on the questions raised. The industry members will work in collaboration with the IOM and other study sponsors to develop a statement of task focused on the "who, what, when and how" of data sharing, including a governance framework that addresses concerns relating to patient privacy, confidential information and scientific integrity. Upon completion of the IOM study and the availability of actionable recommendations for moving forward, they will also seek to gain broad adoption of a unified approach applicable to all groups involved in generating or sponsoring clinical trial data, including industry, academia, government and private foundations.
This industry group is strongly in support of enhanced access by third party researchers to clinical trial data generated by industry and academia in a manner that ensures that patient confidentiality is preserved, scientific integrity is maintained, and intellectual property rights and confidential company information are protected.
On a global level, the companies represented here currently register industry sponsored clinical trials with innovative medicines in patients on a public registry (e.g. clinicaltrials.gov), and are already disclosing summary results of these clinical trials through publicly accessible websites. The outcome of the planned consensus study will provide the basis for a model to further enhance access to clinical trial data, and in doing so, contribute to improved scientific exchange, increased knowledge generation, and greater public understanding of the benefits and risks of medicines.
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*[The BioPharmaceutical Industry's Chief Medical Officers' (CMOs) Forum is a convening group of pharmaceutical and biotechnology representatives where CMOs discuss critical cross-industry medical issues and identify opportunities to jointly improve patient care.]