Patient First Approach
In a recent issue, Clinical Leader asked an expert whether involving patients in clinical trials can achieve better outcomes. Jill Platko, Ph.D., senior scientific advisor at CRF Health, a CRF Bracket Company, explained that “patient-centric research is a concept that puts patients at the heart of a clinical trial.” That means that patients are involved “throughout the lifecycle of a study.” Platko explained why patient voice is necessary in clinical research and how to achieve successful patient engagement.
According to Platko, clinical trials are designed to produce products that help patients, meaning that patients are an important part of this industry. Because it is “counter-intuitive to then ignore them during the research phase,” it is “ethical” to involve patients. She added that patient recruitment and retention can be challenging, making it important to understand how to find and keep patients engaged from the patients. “We are very shortsighted if our studies fail because we didn’t involve a key stakeholder,” she said.
To make clinical trials be patient-centric, patients should be able to offer feedback on assessments and schedules or review recruitment and retention strategies during study design, Platko said. While the study is going on, the people conducting the trial need to consider the patient participants’ needs. The burden or inconvenience of participation needs to be addressed. There could be “consent forms with multimedia components to maximize understanding, easy-to-use data collection systems, reminders and guidance to help keep them on track and engagement strategies that recognize them as individuals.”
Platko added, “Many studies also require patients to come in for frequent site visits, and visits may be long and demanding. Many sponsors are considering strategies on reducing travel to sites while enabling patients to keep in touch with site personnel. In some studies, it may be appropriate to share a patient’s data with them during the study. Once the study is complete, patients should be informed of the result of the study.”
According to Platko, “Success can be measured by a patient’s understanding of the study through a follow-up quiz…Patients do learn better with multimedia.” She revealed that the greatest measure of success could be patient recruitment and retention, adding that the present rate of participant withdrawal is 30 percent. Successful efforts at patient engagement should reduce that number.
Platko said that Forte Research has cited 12 reasons why patients withdraw from studies. While the industry cannot change things such as patients withdrawing from clinical trials because of intolerable side effects, some factors involving patient participation can be addressed by “understanding the patients’ needs and accommodating them.”
Platko concluded that what is needed for successful patient engagement is that people who run clinical trials should be able to accept the fact that patients know best what their challenges and interests are and what would work better for them. She recommended that those who run clinical trials ascertain that the patients are involved in the process from start to finish.
