Standardization to Enhance Data Sharing
 (Chapter 5)

Disclosure does not equal transparency, said Frank Rockhold, senior vice president for global clinical safety and pharmacovigilance at GlaxoSmithKline Pharmaceuticals Research and Development, who moderated the session on standardization and governance at the workshop. Data need to be understandable and analyzable if they are to be useful.

The need for data standards in clinical trials being conducted today and in the future is clear, Rockhold said. Standards can improve data quality, enable separate studies to be combined, and facilitate regulatory review. The application of data standards retrospectively to trials conducted in the past involves additional considerations. For example, the use of retrospective data to answer specific questions may be preferable to standardizing data and depositing the results in a repository for future use.

To date, most standards development has been done on a volunteer, ad hoc basis. Greater recognition of the value of standardization may lead to more cooperative efforts and more sustainable standards development models, Rockhold concluded.

Changing the Culture of Research
 (Chapter 6)

Data sharing is a public good, and the actions of the biomedical research enterprise should reflect that good, observed Robert Harrington, Arthur L. Bloomfield Professor of Medicine and chair of the department of medicine at Stanford University. But a variety of disincentives today create a culture that works against sharing. Academic researchers are afraid of losing credit for the work they have done to generate data. Industry is concerned about the loss of proprietary information and potential liability. Patients are worried about privacy. Essentially, every stakeholder associated with clinical trials faces difficulties in moving toward a more open system.

Good will and altruism go only so far in changing a culture, he said. Additional incentives are needed for substantial and enduring change to occur. For example, several factors came together to create powerful motivations for investigators to register trials at New

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