Sponsors Might Share Research Committees As Pressure Mounts To Share Data

Novartis official says the firm is considering using the same committee as other sponsors to review requests from researchers for data access; stakeholders ask for seats at the table and data interoperability.

Sponsors already are thinking of consolidating some data-sharing operations as a new operational approach facilitated by the Pharmaceutical Research and Manufacturers of America is beginning to take shape.

A number of companies are preparing systems that will facilitate the release of their clinical trial data to investigators and others, part of an industry effort to enhance transparency as regulatory authorities across the globe mull policies that would force public data disclosures.

PhRMA’s data sharing principles, released earlier this year, would allow access to company data after research requests are vetted by independent committees of experts.

Some firm are considering shared use of the same expert panel to review and approve their data requests. Patient groups and other stakeholders are urging that the data released from each firm should be interoperable, which could become a challenge because of its high cost.

Review committees could begin considering data requests in January, when implementation is scheduled to begin.

John Orloff, Novartis AG chief medical officer, said Oct. 15 during a PhRMA discussion of data sharing standards that the company is creating its own independent panel and has commitments from a number of external experts, but also is “exploring the possibility of sharing the panel with other partners like [GlaxoSmithKline PLC], for instance.”

Under PhRMA’s principles, panel members would evaluate the researcher’s qualifications and proposal legitimacy and make a decision on whether to release the data.

Increasing the process’ efficiency is expected to eventually win out and a number of companies could begin sharing committees.

Experienced committees likely would make decisions about requests faster, thereby accelerating the potential for new breakthroughs.

Justin McCarthy, Pfizer Inc. senior VP and associate general counsel, said after the PhRMA panel that most companies will create their own panel initially, but likely share one eventually. He said now it is much easier to develop separate committees because no one has any experience with them.

The PhRMA principles also require companies to make clinical study report synopses publicly available and commit to publishing trial results whether they are positive or negative (Also see "Clinical Data Disclosure: PhRMA Principles Rely On Review Boards To Screen Research Proposals" - Pink Sheet, 24 Jul, 2013.).

Rare disease and other advocates are hoping increased data sharing can lead to drug repurposing and new treatments. But industry officials also warned increasing the data available will not always lead to new indications (Also see "Clinical Trial Data Release: Be Careful What You Wish For, Industry Exec Says" - Pink Sheet, 22 Jul, 2013.).

Committee Independence Questions?

Barbara Bierer, senior VP at Brigham and Women’s Hospital, said there may be questions about the extent of the review committees’ independence.

Bierer wondered whether committee members, appointed by a pharmaceutical company, could determine some data would never be shared, no matter the request. She suggested regulators, academics and others be included on the boards and also that they allow for a decision appeal process.

“Will those individuals feel somehow compelled [to label] – and can pharma define – certain information as confidential that then doesn’t even reach … an independent deliberative process?” Bierer said during the panel discussion.

The event was organized in part to continue PhRMA’s and others’ push for changes to the clinical data release policy proposed by the European Medicines Agency.

EMA said it plans to release all clinical data and documents without concerns about protection of personal data once a marketing decision is made. Some confidential commercial information will be protected, but industry is worried it could lead to a loss of exclusivity for new products in markets outside Europe.

PhRMA opposes the policy and McCarthy said sponsors may rethink how Europe fits into their development strategies if implemented as is (Also see "EMA Data Disclosure Proposal Could Delay European Fillings, Industry Warns" - Pink Sheet, 17 Oct, 2013.).

Amy Comstock, CEO of Parkinson’s Action Network, said no one body should require data sharing, but there should be financial incentives to encourage it. She said the National Institutes of Health also could use its funding mechanism to promote more data sharing.

“I don’t think that in the private sector we want a rule from on high about sharing the data,” Comstock said. “I feel very differently about NIH-funded research. … I think NIH doesn’t do nearly as much as it could with the power of the purse and they could be much more aggressive about requiring academic researchers to share.”

Stakeholders also encouraged sponsors to add patients to the review boards in part because of the perspective they could bring to the process.

Patient involvement has been on the rise at FDA following the enactment of the 2012 FDA Safety and Innovation Act. The agency has conducted a number of meetings looking for patient perspectives on specific diseases to help reviewers understand unmet needs and risk tolerance (Also see "Narcolepsy Meeting Focuses On Symptoms, But Some Urge Attention To Underlying Cause" - Pink Sheet, 7 Oct, 2013.).

Data Availability, Then Interoperability

Nearly as important as making clinical trial data available is ensuring it is interoperable, stakeholders said.

Companies and regulators around the world need to commit to using similar definitions for data points and formats, Bierer said. She also said government research should be subject to the same requirements, but likely do not have the resources to do it.

“I think that (interoperability) gets even more complicated if we think about it in a global environment,” Bierer said. “We need to find a way of harmonizing this.”

Ideally, if the data could be pooled, trials could become easier to design, new endpoints could be discovered or disease models created.

Orloff said interoperability has been a goal for some time, but the first step is to release the data.

The Critical Path Institute has helped launch data-sharing initiatives in Alzheimer’s and Parkinson’s diseases to enhance trial design efforts.

The group also helped create a database of Alzheimer’s trial control data and data standards for it and other diseases (Also see "E-Submission Part Of FDA Reg Reform Plan; Alzheimer’s Data Standard About To Debut" - Pink Sheet, 29 Aug, 2011.).