The discovery and development of new medicines for patients is a comprehensive, data-driven process that requires years of research. At the heart of this endeavor is the clinical trial, the rigorous and highly-regulated scientific study of potential new medicines.
Clinical trials feature careful collaboration among sponsoring companies, regulatory agencies, investigative site staff, medical professionals, hospitals, academia, institutional review boards and ethics committees, as well as the patients who volunteer to participate. The Food and Drug Administration (FDA), along with international standards such as the Guideline for Good Clinical Practice of the International Conference on Harmonization, govern the safe and ethical conduct of clinical trials. Additionally, our member companies agree to PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. The clinical trial process is the safest and most productive it has been in history.
A recent inflammatory and one-sided article in Newsweek story recycles old claims about clinical trials, ignores the extensive access to clinical data now available to researchers and mischaracterizes the industry’s position on companies’ clinical trial data sharing. The article flippantly compares clinical trial research and analysis to baseball statistics. To the biopharmaceutical sector, this is not a game, but rather a scientific mission of the highest importance as we seek to improve and extend the lives of patients around the world.
Clinical trial results are routinely shared with government regulators, the academic and medical communities, physicians and the public through submissions to the FDA, presentations at medical conferences, publication in peer-reviewed journals and registration on ClinicalTrials.gov, the clearinghouse of clinical trials maintained by the National Institutes of Health. As of today, ClinicalTrials.gov reported 178,655 studies in 50 states and in 187 countries. The biopharmaceutical sector is among the most transparent research-intensive industries; few others publish the research findings that power their products.
In July 2013, PhRMA and our European sister association EFPIA (European Federation of Pharmaceutical Industries and Associations) issued joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers, which further the industry’s longstanding commitment to public health, foster additional scientific discourse and reinforce the fundamental protection of patient privacy. The PhRMA-EFPIA commitments dramatically increase the amount of information available to researchers, patients, and members of the public. Key aspects of the principles include:
- Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data are encouraged to publish their findings.
- Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.
- The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
- Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
These principles are being implemented by biopharmaceutical companies in the U.S. and Europe. Importantly, the access to clinical data is not only advancing science, it is protecting patient privacy, which is critical for current and future trial participants. Just a few examples of the industry’s data sharing programs include:
- Pfizer created a comprehensive data access policy and web portal to facilitate researchers, trial participants, regulators, and others acting in the best interest of patients to have access to clinical trial information to advance medical understanding and progress.
- The GlaxoSmithKline (GSK) Clinical Study Register provides an easily accessible repository of data from GSK-Sponsored clinical studies, supplementing communication in journals, at scientific meetings, in letters to healthcare professionals, and in approved prescribing information.
- Johnson & Johnson partnered with the Yale School of Medicine’s Open Data Access (YODA) Project which serves as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, the pharmaceutical companies of Johnson & Johnson, and make final decisions on data sharing.
- EFPIA maintains a Clinical Trial Data Portal, offering easy access to member companies’ online trial data sources.
In addition to the company efforts, there are numerous public collaborations such as Project Data Sphere that not only aggregate data but bring together the best scientific minds to produce new analyses and tackle the most pressing questions in drug development. The bottom line is that there is an unprecedented level of responsible clinical trial data sharing happening right now, all to the benefit of current and future patients.
Josephine Martin Josie Martin is Executive Vice President of Public Affairs at PhRMA. In a career spanning over 20 years, she worked on the Senate Finance Committee, The American Red Cross and has touched many facets of healthcare communications, from anti-smoking campaigns and getting America fit to cancer awareness.