Clearer Road Ahead

There is little doubt that the issue of clinical-trial registries will remain front and center in 2005. The objective is to make information about clinical trials -- both initiation and results -- available to healthcare professionals and the public in an unbiased, scientific, and timely manner. From the perspective of pharma companies, a trial registry can be used by investigators to facilitate patient enrollment in clinical trials. Today's registry movement began in Section 113 of the FDA Modernization Act of 1997. In addition to government and industry-wide policies, many companies have unveiled more detailed plans to increase the amount of clinical-trial information that is publicly available. Several legitimate concerns are being raised by pharma companies regarding some of the proposed clinical-trial registry requirements and expansions: 1. interpretation, 2. confidentiality, and 3. expense. Creating a more comprehensive registry should result in increased public trust, greater clinical-trial participation, and enhanced consumer welfare.