Harlan Krumholz, Yale University School of Medicine, had previously reminded the workshop participants that to restore trust in clinical trials, investigators need to listen to people so as not to seem “self-serving even as we are trying to promote society’s best interest.” With that in mind, principles could be adopted that would govern the return of information to research participants. Many trialists do not make enough effort to let participants know the results of the trial and what the implications are for society, let alone for them as individual patients, he said. It is easier to end a trial and “not have an individual interaction with the participants to make sure that they understood what had accrued as a result.” People who are persistent often can get information about their assignment in a trial, but most trials do not provide the information as a service and in an easy-to-understand way.

Deborah Zarin, National Library of Medicine, observed that such decisions are the province of the institutional review board. Each trial would have its own guidelines, which would be laid out during the informed consent process. Rob Califf, Duke University Medical Center, agreed that there could be a standard and that it could be articulated fairly easily. “In general, there should be an obligation to inform participants in clinical trials about the result of the trial,” he said. In most cases, participants can be informed about whether they got a treatment or placebo after the trial concludes. But making sure that a participant can put his or her individual assignment in the context of the results of a trial will take time and effort.

The Need for Leadership

Sharon Terry, president and chief executive officer of Genetic Alliance, concluded the workshop by observing that far too few people are participating in clinical research. When fewer than 10 percent of the population is engaged, either through participation in trials or through citizen science, the system is broken, she said. We need to find ways to involve many more people in biomedical research. Disease-specific and cross-disease advocacy or interest groups already exist that could foster this involvement. Industry has demonstrated its willingness to participate and increase its sharing of data. Researchers in specific areas have moved toward models of cooperation and data sharing.

Terry reminded the group that it is a mistake to refer to patients as “them” and to researchers as “us.” Everyone is either a patient or a po-



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