Pharmaceutical Trade Groups Endorse Data Sharing, with Conditions

Two major trade groups in the United States and European Union, PhRMA and EFPIA, recently pledged to increase the amount of drug trial information available to researchers. But what level of transparency would be afforded to patients?

Following GlaxoSmithKline’s lead, 2 major trade groups in the pharmaceutical industry, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), have pledged to make data collected during clinical trials more readily available.

The organizations have released a document entitled “Principles for Responsible Clinical Trial Data Sharing” expressing their position on increased transparency. As an article in The New York Times pointed out, this document differs from the proposal on transparency released by the European Medicines Agency (EMA) earlier this year, which called for a policy with fewer restrictions on who could access the data.

“Our principles are a responsible alternative to the EMA proposal,” a representative from PhRMA told Specialty Pharmacy Times. “Government disclosures of companies' unprocessed non-contextualized raw data and technical analyses will provide little benefit to practicing health care professionals and patients, and could potentially jeopardize public health in the long run.”

The PhRMA/EFPIA transparency pledge details pharmaceutical companies’ commitment to sharing patient-level clinical trial data, study-level clinical trial data, and protocols and reports from clinical studies. However, it would limit the disclosure of such information to “qualified scientific and medical researchers upon request,” and disclosure would be “subject to terms necessary to protect patient privacy and confidential commercial information.” According to the pledge, parties requesting drug trial data would have to establish their qualifications and submit information to “document the legitimacy of the research question” in order to prevent competitors from gaining access to trade secrets or proprietary information.

Under the proposal, data on individual patients would be provided in synopsis form and would go through several stages of edits before being released. If there were a “reasonable likelihood” that a patient could be re-identified through the sharing of specific data, manufacturers would be allowed to withhold it. The proposal also notes that researchers would be expected to publish their findings based on any clinical trial data they receive and would need to submit a plan for publication in their initial data request. This publication plan would also factor into the manufacturer’s decision regarding whether to release trial data to the requestor.

Some researchers have objected to some of the data sharing conditions proposed by PhRMA and EFPIA, saying they are vague and filled with loopholes, while others believe that revealing raw, individual patient data would not be of much use to patients anyway.

"Without the proper context, transparency on its own is meaningless,” said Yin Ho, MD, MBA, chief executive officer of Context Matters, a data analytics company that works with the pharmaceutical industry. “In the case of patient-level data, that would be like clearly seeing the individual pixels in a high-resolution picture without knowing the relationship of the pixels to each other. Patient-level data cannot be scaled up by city, state, or country level, so at a close-up view we shouldn't expect it to provide any kind of meaningful trends or high level insights … Only when you step back and see how the pixels relate to each other do you gain a full understanding of what the picture is.”

John Castellani, president and chief executive officer of PhRMA, also emphasizes the importance of providing data in proper context. “Dumping millions of pages of clinical trial information into the public domain without providing appropriate scientific and clinical context or guidelines for meta-analysis could lead to second guessing of the expert decisions of national regulators worldwide, undermining patient trust and confidence in the safety and effectiveness of approved medicines,” Castellani wrote in an editorial published online July 9, 2013, in BMJ.

Although EMA representatives declined to comment on EFPIA’s and PhRMA’s data sharing proposal, the agency noted in an email to Specialty Pharmacy Times that its own initiative to publish clinical trial data “is about establishing trust and confidence in the system.”

“From the start, the EMA has taken a considered approach in designing its policy for proactive access to clinical trial data, which is based on respecting the views and concerns brought forward by all our stakeholders, including pharmaceutical companies, patients, consumers and healthcare professional groups, and the scientific community,” the statement noted. “The draft policy has been designed to balance out the commitment to give widest possible access to data for independent scrutiny with the need to protect personal data as well as what the agency believes to be commercially confidential information.”