Thanks to workshops and other outreach, Merck has gleaned valuable information about how to better work with patients and improve clinical trial efficiency, says Madeline Geday, associate director of clinical research with the company.
“Sponsors want to collaborate with patients to develop clinical research studies so that patients are more satisfied with study design, procedures, and trial outcomes,” she told attendees of the Clinical Trial Protocol Optimization and Design Congress on July 17 in Philadelphia, Pa.
At Merck, “We realized that by not putting patients first, we were often making the wrong assumptions in trial design and [enduring] more late-stage failures,” Geday added. Focusing on the patient’s experience before, during, and after the informed consent process yields a number of benefits, she said. Important lessons manifest at the very beginning, such as, “Don’t call [the patient] a subject, or a randomized number—treat them as human beings.”
Patients also want to be thanked for their involvement. Perhaps more important: Tell them how they are making a difference, Geday said.
Benefits from improving the patient’s experience in clinical research studies include:
- Ensuring you are creating studies that are meaningful to the patient
- Engaging patients throughout the study
- Empowering patients to influence informed consent and make trial-related documents more understandable
- Ensuring recruitment of the right patients
- Improving follow-up
- Increasing retention
Sponsors can learn a lot from patients in a number of areas by asking some key questions, including:
- How do patients experience their disease? (What is a “day in the life” of a patient?)
- What would define “success” from the perspective of a patient?
- How will the trial design impact the patients’ lives?
- What trial modifications would patients need in order to enroll, participate, and be compliant?
- What data are meaningful to patients?
Merck has leveraged several different approaches to connect with patients. Those include:
- Patient dialogues on trial design and patient recruitment and retention
- Scientific input engagement meetings (including with patient advocacy organizations)
- Patient-focused exit survey initiative
- Patient input forums
- Industry roundtables on patient engagement
- Patient materials for trials designed with their “health literacy” in mind
Author: Michael Causey