A forum for chief medical officers (CMOs) from the biopharmaceutical industry has welcomed plans by the US Institute of Medicine (IOM) to conduct a consensus study on responsible sharing of clinical-research data.
The study is a follow-up to a workshop on data-sharing hosted by four groups within the IOM – the Forum on Drug Discovery, Development and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Translating Genomic-Based Research for Health – in October 2012.
The IOM will seek input from a broad range of stakeholders, including academic institutions, industry, patient advocates, non-profit organisations, medical journals, healthcare providers, government, and international regulatory agencies, noted the biopharmaceutical industry’s Chief Medical Officers’ (CMOs’) Forum.
The Forum is a group of pharmaceutical and biotechnology companies, including AbbVie, AstraZeneca Pharmaceuticals, BiogenIdec, Bristol-Myers Squibb, EMD Serono, GlaxoSmithKline, Janssen, the Pharmaceutical Companies of Johnson & Johnson, Eli Lilly, Merck & Co., Novartis, Novo Nordisk, Roche and Takeda Pharmaceuticals International, that convenes to discuss critical cross-industry medical issues and to identify opportunities for joint action to improve patient care.
AbbVie is currently suing the European Medicines Agency to prevent the release of patient-level clinical-trial data on its blockbuster Humira (adalimumab).
Workshop summary
The IOM, which is the health arm of the US National Academy of Sciences, published a summary of the workshop discussions late last month.
The report looks at the benefits of data-sharing to scientific knowledge, public health, and research and development; barriers to sharing, such as concerns about privacy and commercial confidentiality, the effort required to de-identify data, or career incentives to academic researchers; existing models for sharing clinical-trial data; and the need to ensure genuine transparency through means such as data standardisation.
Rigorous process
As the CMOs’ Forum points out, the IOM applies a “rigorous research process to develop objective and straightforward answers to difficult questions of national and international importance”.
While the statement of task for an IOM study is developed in collaboration with sponsors, the study committee works independently to reach consensus on the questions raised, the Forum adds.
Industry members will work 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”, the CMOs’ Forum says.
Unified approach
Once the study is completed and there are “actionable recommendations” for moving forward, these industry members will also be looking for “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.
According to the CMOs’ Forum, it “strongly” supports 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”.
