obligation to ensure that the efforts of those subjects contribute as much as possible to knowledge generation.” Such transparency will also be essential to ensure the continuing flow of individuals who are willing to participate in trials, Krumholz added.
In return for the privilege of selling a medical product to the public, industry bears a responsibility to ensure that all the data concerning the risks and benefits are available to everyone, said Krumholz. The current challenge is not to decide whether data should be released, but how to do so while being attentive to the needs and concerns of all stakeholders. In addition, the publication of summary results is not enough, according to Krumholz. Rather, individual patient-level data need to be broadly and freely available for investigators. “We need the protocols and case report forms. We need full sharing of the source data…. With the talent in this room, and with those listening on the webinar and those who are interested, I know solutions can be found. If we are committed to the path, we can figure out how to do it.”
Jesse Berlin, vice president of epidemiology for Janssen Research & Development, LLC, provided a countervailing view by asking whether participant-level data are always needed. Complications can arise when the data are reexamined, he said. Decisions may have been made during a clinical trial that cannot be replicated. Published studies may not always incorporate the appropriate intent-to-treat analysis. Endpoints may be defined differently in different trials. Study designs, patient populations, and treatments can vary from trial to trial. As a result of these and other potential problems, such analyses can go “seriously wrong,” Berlin warned. “It is not just a matter of feeling more comfortable having the individual-level data. You can actually get wrong answers.”
Although there is a common belief that participant-level data can enable verification and reproduction of trial results, that premise is reliant on the trustworthiness of the shared data, warned Peter Doshi. Even participant-level data can lead investigators astray. For example, a computerized database of participant-level data may not reflect what is actually recorded on a case report form. In some cases, it may be necessary to look beyond what people typically consider data (i.e., numbers) into more narrative forms of documentation depending on the intended use of the shared data.