IOM to develop consensus study on strategies for sharing clinical trial data
The Institute Of Medicine (IOM) plans to follow up on its recent workshop, Sharing Clinical Research Data, by developing a consensus study on strategies for sharing clinical trial data.
As discussed at the workshop, the benefits of sharing data, including the identification of new drug targets, validating targets, identifying new indications for use and enhancing safety and efficacy are increasingly recognized by drug developers, regulators, patient groups, medical journals and providers. This realization has moved the conversation around clinical trial data sharing from whether it should occur, to how it can be enabled. As data holders are beginning to individually generate policies for clinical trial data access, better alignment among stakeholder actions will be necessary to harness the full potential of data sharing.
The IOM is currently organizing a planning activity that will focus on developing an independent consensus study that would provide guidance on the responsible sharing of clinical trial data. A small planning meeting for potential sponsors and key stakeholders will be held in the near future.