sharing study protocols on evaluation of trial results, Doshi cited a trial on the use of celecoxib (Celebrex) in the treatment of osteoarthritis and rheumatoid arthritis (Silverstein et al., 2000). Availability of the original study protocol allowed investigators to determine that the trial had been misreported, including the key claim that Celebrex was safer than alternative treatments (Hrachovec and Mora, 2001).

However, although the partial release of data may seem preferable to not having any data released, challenges with this model need to be considered. For example, partial release of data where trial organizers are allowed to decide which information to publicize creates the potential for selection bias.

THE BOUNDARIES OF PRECOMPETITIVE COLLABORATION

Many of the data-sharing initiatives discussed during the workshop, such as the Datasphere Project, the Coalition Against Major Diseases and ePlacebo, involve the pooling of data from placebo or comparator arms of trials. The value of such initiatives was clearly acknowledged; for example, Janet Woodcock, director of the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), indicated that by sharing the placebo group, one can decrease the numbers of people one needs to enroll in a clinical trial. However, added value of and barriers to sharing active treatment arm data was a notable topic of discussion. The successes that emerged for cardiovascular disease (see Box 2-2) were raised as motivation for making the sharing of these kinds of data a high-priority action.

Carolyn Compton, Critical Path Institute, talked about this issue in the context of defining the boundaries for precompetitive collaboration. Companies need to think about what they can collectively gain by pooling not only data, but expertise and other resources, “so that they all get something that none of them could acquire on their own,” she said. People will need to get past their anxieties over intellectual property (IP) in order to get more benefit out of money they have already spent and data they have already collected, both from successful and failed trials. Michael Cantor, Pfizer Inc., added that it is not just about the IP risk. There is also a lot of concern about the potential of uncovering previously undetected safety signals when one starts pooling data. Questions remain about what role the FDA could play in helping to sort out the



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