Investigators working on clinical trials should be rewarded for sharing the data generated by those trials through protocols and methods that ensure “the more data are used, the more credit trialists receive”, two researchers from Yale University School of Medicine in the US have urged.
“The full potential of the clinical research enterprise can be realised by creating a culture that promotes sharing and provides credit to those who do – and consequences for those who do not,” write Drs Joseph Ross and Harlan Krumholz in an article for JAMA
Ross is Assistant Professor of Medicine (General Medicine) at the Yale school while Krumholz is Professor of Medicine (Cardiology) and Professor of Investigative Medicine and of Public Health (Health Policy).
Both are seasoned campaigners for transparency in the publication of clinical-trial data
Both also belong to a team funded by Medtronic at Yale to conduct an independent analysis of individual participant data from clinical trials of device manufacturer Medtronic’s recombinant human bone morphogenetic protein-2 (INFUSE Bone Graft), following allegations in a medical journal that study results had overstated the product’s benefits.
Citing by now familiar complaints about selective dissemination of clinical-research data, such as nearly half of clinical trials never being published, Ross and Krumholz call for “an era of open science through data-sharing”, to make sure patients and clinicians can make fully informed decisions about pharmaceuticals, biologicals and medical devices tested in clinical trials.Sharing “maximises the value of collected data and promotes follow-up studies of secondary research questions using existing data”, Ross and Krumholz say.
It also minimises duplication, lowering research costs and reducing the burden on study participants, while “positioning clinical trial data as a public good”.
Data management and analytic decisions “have critical implications for interpretation and should be evaluable”, the researchers argue. “If science is to be progressive and self-correcting, then data, not just summary conclusions, must be open to independent scrutiny.”
Ross and Krumholz acknowledge the concerns raised by clinical-trial investigators and funders about data-sharing.
Some investigators “are hesitant to share data because of associated financial costs, and the possibility of inappropriate data uses – including misleading secondary analyses – and because sharing may foster competition that they consider unwelcome”, they point out.
Trial funders, and in particular industry, have warned about potential misinterpretation of risks and benefits, dilution of patient confidentiality, and deterrents to future medical innovation if would-be competitors had access to confidential commercial information.
These concerns, while understandable, “should not stand in the way of compelling societal interests”, Ross and Krumholz assert.
Given their role in generating the data, trialists “will necessarily have first access to the data for analysis and publication”, they write.
“However, the ultimate goal should be to share data and knowledge. To reward the trialists’ contributions to work done by others, protocols for sharing and methods to acknowledge and cite trialists’ contributions need to be developed so that the more data are used, the more credit trialists receive.”
Transparency of data and protocols, including details about interventions, recruitment and other technical issues related to trial conduct, as well as the full trial results, should “allay the concern that only those who conducted a study can understand the data”, Ross and Krumholz maintain.
As for the interest of funders, “the privilege of selling a medical product should be accompanied by a responsibility to share all clinical research data relevant to evaluating the product's risks and benefits”, they add.
Recent initiatives such as data-sharing policies formulated by research funders such as the Gates Foundation or the US National Institutes of Health, as well as industry stakeholders like Medtronic and GlaxoSmithKline, are a welcome step forward, the authors believe.
All the same, “details of the GlaxoSmithKline effort are pending, and the Medtronic effort, which entailed full release of data, involved only one of its products”.
Last October, Ross and Krumholz note, the US Institute of Medicine held a two-day workshop bringing together diverse stakeholders, including funders, journal editors, investigators and patients, “not to discuss whether clinical trial data should be shared, but to explore how it can best be shared to benefit patients”.
The imperative, they conclude, is “to find successful pathways to share data that are attentive to all stakeholder needs, yet serve the best interests of society”.