By admin 
Every day, across the United States and around the world, scientists are developing potential new medicines and vaccines that could change lives. But to get medicines and vaccines to the patients who need them most, they must first undergo a clinical trial, which is a research study that seeks to understand how potential medicines and other medical treatments work.
These studies depend on the generosity of participants, who volunteer to be a part of the trial. Depending on the type of trial, healthy volunteers are needed, and so are people with specific health conditions. “Clinical trial participation is arguably one of the most altruistic gestures anyone can make,” says David Scholfield, who is Head of Clinical & Medical Writing – Clinical Development and Operations with Pfizer.
Pfizer strives to provide the best clinical trial experience possible, from start to finish, says Scholfield. At every step along the way, that entails putting the patient at the center of the work.
“They are trusting us as a study sponsor to do right by them,” says Scholfield, “and that means informing, educating and engaging with them upfront, and making sure we optimize their experience throughout the clinical trial.”
To understand what this patient-centered focus looks like in action, we spoke with three Pfizer representatives who help shape participant experiences from the earliest moments, starting with how individuals learn about clinical trials, progressing to capturing patient voices to shape the clinical trial design, and ending with a commitment to returning certain health data—in an easy-to-understand format—that may assist participants with gaining more insight into their health and allowing participants to easily share that information with their own doctors. They had a lot to share about the evolving world of clinical trials.
Improving access for clinical trial participation
Finding the right volunteers at the right time to participate in clinical trials can be challenging, says Sara Pierson, Head of Participant Ecosystem with Pfizer. “Clinical trial participation can be cumbersome,” she says. Some would-be participants don’t know how to search for a clinical trial, nor how to enroll. And many people are unfamiliar with how clinical trials even work. Pfizer is working to change that through education and improved access. At PfizerClinicalTrials.com, individuals can learn about clinical trials and their critical role in medical breakthroughs. They can also glean practical advice, such as how to prepare for a clinical trial and what happens when it ends. Those who are interested in finding a clinical trial can search for Pfizer clinical trials that are currently recruiting.
Pfizer is also connecting with potential participants through PfizerLink the first industry-sponsored research registry that allows interested individuals to share some basic information about their health and medical areas of interest so that they can be contacted for future clinical trials. “PfizerLink provides people who are actively interested in participating in a clinical trial an opportunity to stay interested and engaged,” says Pierson.
Since its launch at the end of 2022, more than 35,000 people have joined PfizerLink. By 2032, the goal is to register 1 million people. Making it easy for them to join and participate, says Pierson, will benefit all involved.
“Easier access allows for broader participation by ensuring that people who want to participate are able to participate,” she says. “That, in turn, allows us to have better quality data, which means better scientific findings and accelerated approvals for medicines and vaccines that can really help people.”
Shaping studies for a better patient experience
When Scholfield reflects on the history of clinical trials, he says that traditionally, scientists have understandably had a laser focus on designing the most scientifically rigorous trials. These trials may not have always incorporated elements designed to optimize the experience of the patient.
In recent years, however, that’s been changing. “There’s been a growing appreciation of the under-appreciation of the patient’s experiences,” says Scholfield.
At Pfizer, Scholfield and his team frequently seek feedback so they can incorporate the patient’s voice in the design of the trial. That might entail, for example, partnering with patient advocacy groups to design collaborative patient surveys inquiring about topics like patient priorities, the effects of their health condition that matter most, their preferences for potential treatment options, and more. They’ve also sought input on more practical areas, such as how many assessments or clinic visits are manageable vs. burdensome. And they’ve made efforts, when possible, to offer decentralized clinical trials, which allow the patient the flexibility to participate in a study, or to complete certain study required activities, from their own home. “Ultimately,” says Scholfield, “we’re trying to make sure that we’re not doing anything that’s unnecessary in order to answer key research questions.”
By including the patient’s perspective in clinical trial design, Scholfield says the benefits ripple through the study itself, and may positively benefit participant retention and reduce dropouts. “What we want to do is to make patients feel as though they’re being looked after. What we don’t want to do is add to their burden,” he says. “We owe people that.”
Helping the participant access (and understand) certain clinical trial data
When a person volunteers to participate in a clinical trial, they’re making a significant commitment to advancing science, offering their time, their experience, and certain personal information, says Paula Boyles, Program Lead for External Data Sharing with Pfizer, and for that, they should feel appreciated and receive their own health information where they can glean insights from the study. That’s why Pfizer launched the Participant Data Return Initiative, which gives participants the option to access certain aspects of their own data from the clinical trial, once complete. “It’s really the right thing to do for participants,” says Boyles. “We have an obligation to give them back data that they contributed to the study.”
In 2023, Pfizer was the first biopharmaceutical company to take this step—a decision that stemmed from participants requesting to know more about their experience. For example, were they given the investigational drug or a placebo? How did their bodies respond to the study? By offering to share certain clinical trial data, written in plain language and designed for non-scientists to understand, Boyles believes Pfizer is helping to empower all participants with information related to their contribution to the study.
Beyond certain individual clinical trial data, Pfizer also shares easy-to-understand summaries of its clinical trials with the public. These Plain Language Study Results Summaries (PLSRS), offer the most relevant study information to participants, healthcare providers, caregivers, researchers, and others via Pfizer.com. Boyles hopes that, together, these initiatives will help people to be more informed and engaged on their health in the long term.
Building trust
When a person agrees to participate in a clinical trial, they’re putting great trust in science. That’s an honor and a privilege that the entire Pfizer team takes seriously.
“We’re carrying out research, and we’re developing new medicines and vaccines to help improve the lives of our patients. We can’t do that without each study participant’s help,” says Boyles. “We need them to volunteer and participate in studies. And when they do, it’s vital that they feel seen and appreciated.”