Investigating with Integrity
Clinical trials and the people who participate in them play a vital and heroic role in bringing new breakthroughs to patients. Pfizer is committed to improving the effectiveness and efficiency of clinical trials, while protecting the safety and interests of clinical trial volunteers.
We conduct our clinical trials, wherever they take place, to consistent ethical standards, comply with applicable laws and regulations, and fully protect the rights and welfare of trial participants. We integrate quality management principles into the clinical trial process, maintaining vigilant oversight over all trials, including those conducted for us by contract research organizations. To assure patient safety, data integrity, protocol adherence and regulatory compliance, we routinely monitor clinical trial sites and audit the data generated in studies.
Pfizer has created a discipline around clinical innovation, to make research participation easier for patients and health care providers. We are using new approaches and partnerships for clinical trial recruitment, particularly in the drive to increase the diversity of participants. Mobile health, social media and health information technology offer new ways to capture data and insights from patients, enhance the patient experience, and coordinate the clinical trials conducted in partnership with thousands of independent researchers.
Pfizer Link, an
alumni network for study subjects who have completed their participation in a Pfizer-sponsored clinical trial,
is a unique online patient engagement tool that allows Pfizer clinical trial participants to be more active in the drug discovery and
development process. Pfizer Link provides information on diseases and conditions of interest, suggestions and tools for disease management,
opportunities to participate in future clinical trials, and access to patient registries.
Head of Clinical Innovation within Worldwide Research & Development
Patients make an incredible contribution when they choose to participate in a clinical trial. We are actively finding ways to help minimize burden on these patients and make our studies more patient-friendly, from making study participation locations more convenient to using innovative digital tools to collect data and share information.
Providing Broad Access to Clinical Trial Information
In 2014, Pfizer launched Find a Trial, a suite of web tools for patients seeking clinical trials (pfizer.com/findatrial). Designed to complement existing resources such as postings on clinicaltrials.gov, every actively enrolling Pfizer study is also listed on Find a Trial with, in many cases, greater depth of information. Pfizer has also been partnering with others to improve access to trial information for patients, such as our support for new ways to post and share trial information through the Patients to Trials Consortium.
Starting in 2014, people who enroll in Pfizer clinical trials have the option to receive lay-language summaries of clinical trial results,
in countries where regulations permit. And Pfizer's pilot adoption of
Blue Button® technology (launched by the U.S. Departments of Veterans
Affairs and Health and Human Services) enables trial participants to download their own electronic clinical data.
Investigators who are qualified researchers may request patient-level data for further research via INSPIIRE (Integrated System for Pfizer Investigator Initiated Research), our public web portal for investigator-initiated research (iirsubmission.pfizer.com). The data are anonymized to protect patient privacy. The process is simple: Pfizer reviews research proposals received through the INSPIIRE portal, and an external Independent Review Panel adjudicates any declined requests. Anonymized synopses of clinical study reports filed with regulatory agencies for approved products are also available for researcher use on Pfizer.com.
Pfizer's clinical data access policy and the INSPIIRE data request portal are accessible at http://www.pfizer.com/trialdataandresults.