Pfizer Inc. updated its clinical trial data access policy yesterday, and will soon begin to share data and results with study participants. The pharmaceutical giant also said it will offer researchers access to anonymous patient-level data from trials of already approved products. Although solo, these actions reflect an industry-wide move toward greater scientific transparency as suggested in “Principles for Responsible Data Sharing,” which was issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) during July of this year. Pfizer’s statement may have been inspired as well by recent work from the National Institutes of Health.
Risks of Information-Sharing
In a published account of a recent workshop titled, “Sharing Clinical Research Data,” the Institute of Medicine noted the large quantities of clinical research data possessed by pharmaceutical companies, academic researchers, and government agencies, such as the Food and Drug Administration. “If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development,” the authors write. As described in the report, benefits of sharing data cited in the report included improving research accuracy, strengthening collaborations, accelerating research, enhancing comprehension of the results from an individual clinical trial while enabling a pooling of data from multiple trials to extend discovery beyond a single study. “The moral and ethical arguments for data sharing center on fulfilling obligations to research participants, minimizing safety risks, and honoring the nature of medical research as a public good,” the authors state.
Yet, the authors also take care to describe the significant barriers to data sharing faced by both academics and industry researchers. Within the university, such obstructions include “a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements,” while the barricades in the industry include a fear of data mining, erroneous, and mistaken secondary analyses of data that might lead to unwarranted litigation, as well as a desire to protect confidential commercial information. It is an oft-quoted fact within the industry that only one out of 10,000 potential new medicines, which cost a significant amoung in terms of both cash and effort, makes it through pre-clinical and clinical trials and is approved by the FDA. Less frequently discussed is the fact that companies learn from each other's failures so wider information sharing may directly impact how much can be learned from these expensive failures.
Despite such risks, Pfizer has been slowly loosening its grip on its own scientific information for some time. For instance, Pfizer’s current practice includes submitting for publication manuscripts for all interventional clinical trials in patients, regardless of outcomes, within 18 months of study completion. The company has already put in place a number of safeguards designed to protect patient privacy and commercially confidential information. Under the new policy, Pfizer will require those who want access to sign a data-sharing agreement.
“Access to clinical data empowers today’s patients with information and resources to better manage their health and wellness,” Craig Lipset, head of Clinical Innovation for Pfizer Worldwide Research and Development, stated in a press release. “We look forward to exploring new ways to make this data meaningful and actionable for our trial participants and their healthcare providers.” Pfizer said it will also publish synopses of clinical study reports (CSRs), which are filed with regulatory agencies, and distribute lay-language summaries of results to study participants, starting with trials that begin enrollment during 2014. Soon, study participants will even be able to download their own electronic clinical data collected during clinical trials.
According to its 2012 financial statements, Pfizer's revenues decreased 10% in 2012 to $59.0 billion, compared to $65.3 billion in 2011, which the company attributes, in part, to the loss of exclusivity of its blockbuster cholesterol drug, Lipitor, in most major markets.
Source: Institute of Medicine (US). Sharing Clinical Research Data: Workshop Summary. National Academies Press (US). 2013.