Such standards should apply to public and private funders of research and should provide a uniform template for presentation of results (e.g., the ICH E3 template—currently utilized globally to summarize results for global regulatory agencies). Much of Chapter 4 of this report documented discussions aimed toward reaching a common understanding of what those standards should be.

BALANCED PROCESS FOR DETERMINING WHAT INFORMATION SHOULD BE PROTECTED

A process to protect confidential and proprietary research, yet provide a mechanism for public disclosure as needed, already exists and is familiar to the U.S. Department of Health and Human Services in the area of public health information disclosures—the Freedom of Information Act (FOIA). FOIA exemptions for commercial information and trade secrets, and the consequent process for adjudication, potentially could be adapted for a clinical trial registry. Confidentiality protections are the cornerstone of the National Institutes of Health (NIH) grant submission process. Pending NIH grant applications and unfunded new and competing continuations and competing supplemental applications are withheld, as is “information which, if released, would adversely affect the competitive position of the person or organization.” These rules govern NIH basic and clinical research, including clinical trials.

For reasons similar to those motivating the need to create broad clinical trial registries, FOIA was created in 1966 to give the public expansive access to the records and information in the possession and control of U.S. government agencies. There is a clear public interest in allowing the public access to this information, supported by many of the same reasons cited in support of mandatory clinical trial registries. However, Congress realized that the data in the government’s possession will, in a minority of cases, be very sensitive, and if forcibly made public, could create powerful disincentives for investigators or industry to innovate or share important information with the government. For this reason, Congress created some exemptions from forced disclosure of information in the government’s possession, but also created a process to guard against abuses.

In most situations, the research entity will not be harmed by disclosing primary and secondary endpoints at the initiation of the clinical trial.



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