gathered in this final chapter of the summary as a way to highlight and elaborate on next steps for advancing the sharing of clinical trials data.
As a possible intermediate step in the release of participant-level data, several participants raised the possibility of sharing clinical study reports, which are much more detailed reports than typically appear in a publication or even in an online publication. These reports, which generally contain the methodology, the subgroup analyses, the sensitivity analyses, and other detailed analyses of the data, are “low-hanging fruit” that could add to the information available in publications, without engendering the kinds of concerns raised when sharing patient-level data, said Jesse Berlin, Janssen Research & Development. Peter Doshi, Johns Hopkins School of Medicine, agreed that clinical study reports may be good initial targets for data sharing because they already exist for nearly all trials. Making them available would not be expensive, but would promote research integrity, medical knowledge, and public health (Rodwin and Abramson, 2012).
In fact, some trial organizers have already instituted this practice. Sachin Jain, chief medical information and innovation officer at Merck & Co., Inc., said that starting in July 2011, Merck has included the protocol and statistical analysis plan as part of its submission package to journals. Upon a journal’s acceptance of a manuscript for publication, Merck also provides the journal with the opportunity to post on its website the key sections of the protocol, including the objectives and hypotheses, patient inclusion and exclusion criteria, study design and procedures, efficacy and safety measures, the statistical analysis plan, and any amendments relating to those sections. “The response was terrific,” said Jain. “This is an idea whose time has come.” If external investigators need additional data at the patient level, Merck also has an initiative through which they can approach the company and ask for access. The data request goes to the product teams, who have the opportunity to review the request and ask questions.
Study protocols, which show how the investigators intended to run the trial, collect data, and perform analyses, provide far more detail than can be condensed into the methods section of a journal article, and often include important information from protocol amendments, such as changes to outcome measures. To emphasize the potential impact of