If that giant sucking noise you’ve been hearing lately is COVID-19 taking all the oxygen out of the room for studies of non-virus medications or devices sponsored by your firm or conducted at your site, you’re in good company. The urgency of maintaining, restarting, or launching brand new clinical trials of treatments for other conditions—whether as a matter of your organization’s financial health, your patient population’s most pressing health needs, or both—has many stakeholders in the clinical research enterprise looking for ways to increase and diversify their staff and study participant ranks as quickly as possible.
In a recent webinar hosted by WCG on “Diversifying Clinical Trial Participation: Effective Strategies for Identifying and Recruiting Diverse Patient Participants,” LaTasha Lee, PhD, MPH, vice president for social and clinical research and development with the National Minority Quality Forum, cautioned that “early and meaningful engagement…not just as you are ready to launch your clinical trial, but as you are designing it” is crucial as organizations seek to involve underrepresented populations in medical research to greater extents than have been historically common.
As part of that, Lee said, “You must begin with education and awareness—education of yourself [about] that community’s needs, awareness of the challenges they face as individuals living with [a] disease, as well as education of the community in which you hope your product or device or study may” make a difference. Letting potential participants understand the trial process is key because of historical abuses of minority patients by unethical researchers and a number of ongoing myths about modern research that must be tackled, she added, advising her audience to “put the patient at the center of all that you do.”
Patient advisory boards can be a boon to researchers in this endeavor, noted Kathy Machuzak, director of patient advocacy for nephrology with Retrophin, Inc., who also spoke during the WCG webinar. “Meet patients where they are—community centers, churches, etc.,” she advised. The information gathered from these boards “is helping us to develop a better strategic plan on identifying and engaging with diverse patients,” she noted, as well as learning about their “disease journey.”
Meanwhile, Lee and Machuzak both mentioned the importance to these efforts of diversity within the staff of research sponsors and site organizations themselves, which is a newly announced emphasis at the Icahn School of Medicine at Mount Sinai, according to a recent announcement. The school has unveiled a BioMedical Laureates at Mount Sinai program to increase diversity among its basic and clinical research faculty and reinforce the school’s ethic of mentorship. BioMedical Laureates and a companion program, Junior Laureates, will launch in January 2021, and will each announce new laureates annually.
“This program is among the first programs of its kind in the country that is dedicated to the enhancement of diversity among senior research scientists at an academic medical center,” said Dennis S. Charney, MD, dean of the school and president for academic affairs of the Mount Sinai Health System. “The program will significantly add to our existing efforts to diversify our faculty. A diverse medical and scientific community will drive innovation, enhance clinical care, and enrich teaching and mentorship, fulfilling the mission that drives our work.”
Other initiatives making news lately that are aimed at improving patient recruitment and addressing non-vaccine studies include:
- To diversify patient pools, Inato, a marketplace for matching research sites to clinical trial protocols, says it is offering sites a way to quantify diversity and track their progress. Sites can complete a 14-point assessment that evaluates three facets of diversity (community, research team, and recruitment and outreach approach). Sites receive badges based on their diversity status, and trial sponsors are able to match their protocols to sites with the most proven diversity levels.
- Clinerion and Maxer Consulting have partnered to boost the identification and recruitment of patients into clinical trials in Italy, and to promote safer and more effective clinical outcomes. The partners say their joint mission is to liaise with study sites to increase patient participation in trials to its full potential by offering tools to optimize protocol design, supporting the efficient start-up of local trials, and planning and consistently hitting realistic patient recruitment targets to enable the achievement of total timeline targets.
- Due to limited funds, smaller biotech firms cannot compete in the vaccine race, but some are gravitating their proprietary formulations against the virus in an effort to mitigate the complications and damages caused by inflammation induced by COVID-19. For example, FSD Pharma has joined the race to create a COVID-19 cure using synthetic molecules that mimic cannabinoids in a drug intended to act as an anti-inflammatory; Q BioMed Inc. and its technology partner, Mannin Research, are working on a novel virus-agnostic and host-directed therapeutic for reducing the lung endothelial vascular leakage, inflammation, and cell death that occur during severe viral infection; and Aqualung Therapeutics is developing an anti-inflammatory monoclonal antibody to treat serious, unchecked inflammation and reduce mortality from acute respiratory distress syndrome and ventilator-induced lung injury.
Author: Gary Cramer