Clinical trial participants are at the heart of medical research, and it’s with their help that Pfizer is able to bring life-changing treatments to patients.
But, until recently, clinical trial sponsors like Pfizer have not been equipped to provide participants with their own personal clinical trial data when a trial ends. Pfizer’s team of clinical trial experts have worked for many years to change that by launching the Clinical Trial Participant Data Return Initiative.
This first-of-its-kind program gives clinical trial participants the option to access certain individual data, approximately 12 months after the completion of the Pfizer-sponsored clinical trial they participated in. This, in turn, allows participants to share this data with their healthcare provider after their study participation concludes.
“Sharing data transparently is one of our foundational principles in creating patient-centered clinical trials," says Judy Sewards, Vice President, Head of Clinical Trial Experience at Pfizer. "In responses from global surveys of clinical trial participants, we overwhelmingly saw that patients want to understand their data and know that their participation in the trial made a difference. Returning participants' data is one way we can empower patients with information related to their contribution to the study.”
How clinical trial data return works
The program is designed to make the data easy and convenient to access. At the start of the trial, participants can choose to opt into Pfizer’s secure Pfizer Clinical Trial Alumni Portal. Then, approximately 12 months after the clinical trial ends, participants are notified that they can log back into the portal to access their own data report.
This report includes visuals and easy-to-understand plain language for participants to view. The data includes some clinical trial information collected during the trial, including medical history, vital sign measurements (such as blood pressure), lab results, adverse events or side effects, and which arm of the study they had been assigned to.
From there, participants can download and, if they choose, can share their results with their healthcare provider, either by uploading the file into their provider's patient portal or electronic health record (EHR) or printing their results to share in-person.
Driving better health outcomes
The Clinical Trial Participant Data Return initiative aims to improve health equity, increase transparency, and to potentially help patients better understand their health after participating in a trial.
“When you choose to share your clinical trial data, your treating physician gets a complete picture of your study participation,” says the man who spearheaded this initiative: David Leventhal, Enterprise Clinical Trial Data Sharing Lead at Pfizer. “It can be a jumping off point for conversations with your provider about your experience in the trial and a chance to get answers to lingering questions about your condition."
It also offers valuable snapshots of your health over the course of the trial, including your responses to the study treatment. That can help your provider gain more insight into your condition, Leventhal explains.
Finally, this data provides your physician with study-related medical history—something that can be time-consuming and difficult to compile with your provider, says Leventhal. “It gives you a more complete picture of your health during the clinical trial to easily share with your existing doctor or with a new one.”
Fitting data return into the larger clinical trial experience
Making the clinical trial experience as easy and as rewarding as possible for participants is always top of mind. Providing participants with their own clinical trial data they can bring to their healthcare provider is just one of the many ways Pfizer is working to make clinical trial participation more meaningful for participants.
To that end, Pfizer has previously streamlined the clinical trial experience by establishing a centralized website and call center that makes finding relevant clinical trials easier for potential participants.
Another example of simplifying the clinical trial experience entails offering flexible support to clinical trial participants, such as offering travel solutions or enabling participants to complete certain study activities at home, if they prefer.
In 2021, Pfizer made a move to increase transparency by providing Plain Language Study Results Summaries to the general public. These re ports communicate the outcome of clinical trial results in a manner that’s easy to understand. Plain Language Study Result Summaries were previously only available to trial participants through the Alumni Portal.
“Clinical Trial Participant Data Return takes this transparency one step further. By making certain individual clinical trial data collected during the study accessible to participants, and making Plain Language Study Results Summaries available, it can provide what I call ‘thoughtful closure,’ to help participants better understand the context of their contribution to their clinical trial,” Sewards says.
Working toward a more patient-centric future
Pfizer is the first sponsor to offer to make individual clinical trial data available in detail and at such a large scale. Beginning with U.S. participants, this data is accessible to any clinical trial participant who, at the start of an eligible study, opted into receiving their data. The goal is to expand the program globally. Both Sewards and Leventhal hope it ushers in greater equity and transparency for clinical trial sponsors across the industry.
“We want to elevate the experience for all clinical trial participants” says Leventhal. “We don’t serve every therapeutic area, and Pfizer-sponsored clinical trials may not be available for every patient. But we’re driving a cross-industry effort to return data back to clinical trial participants.”
It will take time before clinical trial data return becomes the norm industry-wide, but Leventhal sees the potential in showing that it’s possible.
In the meantime, Pfizer is focused on expanding the initiative to ultimately return data to participants of all Pfizer's global clinical trials and creating a seamless clinical trial experience for participants worldwide.
“Patients are at the heart of what we do,” Leventhal says. “By giving participants back their data, we can help them to provide their healthcare provider with a more holistic view of their health after their clinical trial experience, too.”