After a recent Institute of Medicine (IOM) workshop on Sharing Clinical Research Data the advocacy group launched plans to develop a consensus study on strategies for sharing clinical trial data. On April 5, 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., announced their support: “[The industry group] 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.”
According to IOM, 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 industry group’s members say they 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.”
The outcome of the planned consensus study, says the industry group, will create a model to enhance access to clinical trial data and contribute to improved scientific exchange, increased knowledge generation, and greater public understanding of the benefits and risks of medicines.
http://www.iom.edu/Activities/Research/SharingClinicalResearchData/Planned-Consensus-Study.aspx