Many investigators and research sponsors are developing processes for patients to provide input on study protocols. “This is important and beneficial to the entire drug development process,” according to WIRB-Copernicus Group Chief Medical Officer Lindsay McNair, MD, MPH, MSB.
There is increasing awareness of the importance of including diverse perspectives and opinions on the IRB. “Most IRBs include members who have personal experience with acute or chronic illnesses and who may have been study participants,” McNair notes.
But since IRBs do not review draft protocols, by the time a protocol is submitted to the IRB it has been extensively reviewed and discussed. “The study protocol may have been carefully negotiated with regulatory agencies, and has been signed off as final,” McNair explains.
At that point, IRBs might require changes to meet regulatory criteria for research approval. However, it is generally too late for IRBs to raise concerns about participant burden or onerous visit schedules that make participation difficult. “Input from prior study participants and patient advocates is much more valuable while the protocol is being conceived and written,” McNair stresses.
Robert Kerns, PhD, and colleagues wanted to learn more about how investigators are going about engaging patients for clinical studies generally, and pain-related trials in particular.1 “The findings largely confirmed the prevailing view that, in contrast to other areas of research, such as HIV and cancer, a focus on patient engagement in clinical pain research, at least in the U.S., is in its infancy,” says Kerns, a professor of psychiatry, neurology, and psychology at Yale University.
Kerns and colleagues provided an overview on key practices used by clinical researchers to engage patients, and explored the benefits and challenges of these partnerships. Kerns says pain researchers would benefit by enacting a comprehensive approach to patient engagement, including identifying practice gaps (e.g., differences and disparities in access to comprehensive pain care). Also, they could identify key questions for thorough study design and enactment (e.g., “What are the most important outcomes of pain clinical trials from the perspective of patients?”). Finally, consider how patients care serve as partners in disseminating results and products of pain clinical studies.
Kerns and colleagues also examined some factors that help or hinder meaningful patient engagement. “For example, engaging people with lived experience of chronic pain in developing study recruitment materials is a recommended approach,” Kerns offers.
REFERENCE
1. Holzer KJ, Veasley C, Kerns RD, et al. Partnering with patients in clinical trials of pain treatments: A narrative review. Pain 2022; Jan 28. doi: 10.1097/j.pain.0000000000002600. [Online ahead of print].
Pain researchers would benefit by enacting a comprehensive approach to patient engagement, perhaps engaging people with lived experience of chronic pain in developing study recruitment materials.
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