During the early months of 2020, decentralized modalities to conduct clinical trials went mainstream as a solution to a short-term problem: how to continue clinical trials amid pandemic closures. At Pfizer, however, remote trials and the use of digital tools to conduct clinical trials were implemented long before the pandemic. Increased adoption of modalities like telehealth visits became catalysts for how — and where — clinical research could be done.

What's more, surveys show that participants report a preference for location flexibility.1 This spurred new questions: How often do participants really need to come to a clinical trial site for appointments? What else could make clinical trials more participant friendly?

“The average time someone travels to a clinical trial is about two hours. Aren’t there ways to leverage technology to help participants avoid this trip, and with it, to avoid getting babysitters, taking time off work, etc.?” asks Jeremy Price, Senior Director and Decentralized Trial Lead at Pfizer. “Is there a way we can reduce this type of logistical burden and make it easier for participants to take part in our studies?”

Telehealth was a good start to make clinical trials more convenient to participants. What else could be possible?

A tradition of patient-centered clinical trials

Decentralized clinical trials weren’t new to Pfizer, which completed its first decentralized clinical trial in 2011.2 During the pandemic, Pfizer continued to lead innovation in this space. Price and Tim Joy, Executive Director and Head of Strategic Solutions, built a cross-functional team of professionals — clinicians, technologists, clinical trial experts — and worked collaboratively with legal and regulatory partners, past participants, and other subject matter experts to brainstorm ways to help increase access to clinical trials for as many people as possible.

“We had a diverse range of skills on the team, and we had the support of leadership, encouraging us to keep pushing forward,” Price says. “This collaborative team shared the goal of designing participant-friendly studies that would offer participants more choices, during and after the pandemic.”

Pfizer’s clinical trial retention rate has already beat the industry standard, Price shares. On average, about 90% of Pfizer’s participants complete a clinical trial, compared to the industry average of about 75%.3 Pfizer’s decentralized clinical trial team brainstormed ways to continuously improve these numbers.

To make trials even more participant-friendly, the team set out to reduce the number of required in-person appointments by about half. They reviewed the clinical trial activities required across studies and in some cases, at each clinical trial visit and evaluated which visits could be performed remotely. “It was not a process of whittling down options; rather, it was designing a menu of choices,” says Price. Just as personalized medicine has transformed patient care, location flexibility and increased adoption of digital tools could transform the clinical trial experience.

“We need a suite of solutions. It’s not one size fits all,” Price says. "After speaking with over 30 clinical trial sites, we learned that the more choices we offer participants, the more accessible clinical research becomes for all.” And Joy adds: “With these choices, we hope that more people will choose to participate in our studies. We need to design studies to meet participants where they are.”

Designing a suite of solutions

In addition to telehealth, here are four ideas that may make clinical trials more accessible to more people:

  • Remote sample collection: Instead of requiring participants to visit a specific clinical trial site to have blood drawn or urine collected, what if they could visit a lab near their home that partners with the trial site? Many participants have labs that are closer to their homes than the trial site; this presents an opportunity to save participants’ time.
  • Alternative study conduct locations: For example, imagine having an exam or a clinical trial activity at the local pharmacy. “The availability of COVID-19 vaccines at local and large retail pharmacies was crucial in their wide adoption during the pandemic,” says Joy. What might alternative study conduct locations do for the accessibility of clinical trials?
  • Home health: Study teams could design certain study visits to be completed at home — medical history and routine physical exams, such as walk tests and blood pressure checks. A healthcare provider working with the clinical trial site could travel to the participant’s home.
  • Mobile units: “We want to bring the clinical trial to participants,” Joy says. “We want to include underserved populations, people who may not live in areas that have access to a clinical trial facility.” Mobile units can be as small as an ambulance or as large as a mobile home, and they could further broaden representation in clinical trials, thereby improving the development of medicines and vaccines for everyone.

“When you hear all this, it seems like common sense. If we perform some of the clinical trial activities remotely, while maintaining safety and quality, let’s do it that way, right?” Price says. “If we can design our clinical trials where participants travel to a site only five or six times a year instead of 12 times a year, they’ll be more likely to complete the required activities until the end of the trial.”

“Patients are waiting”

The Strategic Solutions team’s term “Clinical Trials Anywhere” encompasses many decentralized clinical trial modalities, including study visits: within a participant’s home; just around the corner in a mobile unit or at local pharmacy; or on a smart phone, tablet, or laptop. While this model doesn’t replace a participant’s routine medical care with their regular healthcare provider – which continues throughout their participation in a clinical trial – it makes study visits more convenient and accessible. It could be the difference between someone deciding that trial participation is right for them, or not. "Clinical Trials Anywhere" is considerate of participants’ time and priorities. It’s good science, too. When more people join clinical trials, those trials are conducted with participants who reflect the intended patient population.4,5

“Patients are waiting. What can we do to shorten the time to get medicines to patients faster?” Price says. “One of the many ways to shorten a study is to recruit faster and to keep participants in the study to the end. We want to make sure we design studies that meet people where they are and continuously improve clinical trial participants’ experience. That way, we can finish studies on time, and we can get medicine to patients in need.”