Dr. O’Rourke, representing academic medical centers, expressed concern about databases that include data regarding trials open to enrollment and trial results. “These two types of databases have different goals, different audiences, and require different rules of operation. Realistic goals and rules for those two quite different types of information need to be looked at very seriously.”
The most important issue, according to Dr. Breier, is ensuring that all relevant clinical trial results are available in a comprehensive, objective, and unbiased manner when a prescribing decision is made. “It’s an issue of WHEN, not IF. If a drug is in early development and it is not on the market and it is not available for a prescribing decision, the importance of that information is less so to the patient. The patient cares when the doctor has to make the prescribing decision and he wants all of the relevant information available in order to make the best prescribing decision.” Dr. Breier stated that results reporting is the way to address the file-drawer phenomenon, or failure to report negative results.
GSK Pharmaceuticals has a registry that posts results once a product is approved, on the assumption that disclosing results on a register does not preclude publication, according to Dr. Rockhold. Before the end of the year there will be well over 1,000 trials in the GSK registry. Currently 28 products and more than 500 trials are posted. “I feel strongly that whatever the strategy is, it needs to include the results.”
NLM’s Dr. Zarin noted that NIH is working on a proposal to enhance access to a wider range of information on NIH-supported clinical trials—with positive, neutral, or negative results. They see challenges, though, in reporting results, including verification of results and problems with misinterpretation.