There is no hiding from the transparency movement. The pharmaceutical industry is feeling increased pressure to provide greater access to the data its clinical trials produce. Ultimately, the question now is not if it will share this data, but how—and with whom.

To that end, the US Institute of Medicine (IOM), an independent advisory body based in Washington, DC, held a two-day workshop last month to discuss an interim report that highlights four possible mechanisms by which scientists and trial sponsors can make information generated by clinical studies available.

Committee chair Bernard Lo, president and chief executive of the Greenwall Foundation in New York, describes the four models outlined in the 22 January draft framework as a starting point. The greater objective, he says, is to “focus attention on the specific issues that need to be resolved” in data sharing.

One mechanism proposed by the IOM panel is an 'open access' model in which all clinical trial data would be available to anyone: scientists and the public alike. Another would permit data access only to members of a scientific consortium or defined partnership. The third and fourth models would make trial information—either pooled across multiple data sources or from an individual entity, be it a company or academic institution—available only on a 'controlled access' basis.

Data dilemmas

The research community remains divided over which data sharing model will provide the best balance of advancing biomedical research while still maintaining the privacy of research participants and the competitiveness of drug companies.

“I think open access is best,” says Steven Woloshin, co-director of the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire. “Otherwise there is too much of a chance that [drugmakers] would selectively release information, which would undermine the purpose.” Curtis Meinert, who studies clinical trial methodology at the Johns Hopkins Bloomberg School of Public Health in Baltimore, is less sanguine. “It is unwise to deposit trial data for use without assurance that users will not de-anonymize data,” he says.

Complicating matters is the multinational nature of many clinical trials, which often involve researchers, sponsors and participants in multiple countries. “Different countries have different legal frameworks about intellectual property, informed consent, data privacy and antitrust [laws],” says Lo.

The optimal approach “remains to be determined,” notes Robert Califf, director of the Duke Translational Medicine Institute in Durham, North Carolina. After a public consultation, the IOM expects to issue final recommendations before the end of the year. “This next period of 'trying out' different approaches by different organizations will be a chance to find the best approach for each type of data,” Califf says.