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Insight & Intelligence : Aug 13, 2013
Increasing Minority Participation in Clinical Trials
Three new efforts aim to deliver on years of promises.!--h2>
African-Americans constitute 13.1% of the nation’s population, but only 1–2% of its roughly 10,400 oncologists. The percentage of Latino oncologists isn’t much better at 2–3%, given their 16.9% share of U.S. population.
In the fifteen years following a commitment by the National Cancer Institute (NCI) to increase diversity among investigators as well as patients involved in clinical trials, various efforts have emerged to achieve this goal. Three efforts announced in recent weeks offer some hope that years of words will finally give way to deeds when it comes to increasing minority presence among researchers who carry out clinical trials, as well as clinical trial participants.
Three New Initiatives
Earlier this month, Eli Lilly and the Center for Drug Development and Clinical Trials at the Roswell Park Cancer Institute (RCPI) unveiled a first-of-its-kind program aimed at training 75 to 150 minority oncologists in the conduct of clinical trials. The three-year program will offer a three-day clinical research workshop for minority physicians, “Reducing Cancer Disparities through the Training of a Diverse Workforce.” The program will start next spring and run through 2016.
By end of October, or at least the fourth quarter, the group Pharmaceutical Research and Manufacturers of America (PhRMA) will join the not-for-profit National Minority Quality Forum (NMQF) and Microsoft to launch the National Clinical Trial Network. The network is an online portal designed to link communities of patients, practicing physicians, and researchers, reasoning that greater connectedness will draw more African-Americans and Hispanics to clinical-trial research teams.
Also this fall, the NCI will issue a formal funding opportunity announcement seeking applications for funding through the new NCI Community Oncology Research Program (NCORP). The announcement should come out this fall. The NCI’s Board of Scientific Advisors in June approved formal creation of NCORP, developed over the past year to consolidate the institute’s Community Clinical Oncology Program (CCOP) Network, which includes minority-based CCOPs nationwide and the NCI Community Cancer Centers Program (NCCCP), as well as their research bases.
NMQF-PhRMA-Microsoft Effort to Build Permanent Networks
“Some of the challenges really stem from how clinical trials are structured,” Gary A. Puckrein, Ph.D., president and CEO of NMQF, told GEN. “They’re really built around temporary networks that are created to recruit a specific number of patients into a specific trial. And when the trial is completed, the network comes down.”
Some biopharma companies have sought to address the issue through networks of minority doctors, usually engaged trial by trial, Dr. Puckrein said.
In 2007, AstraZeneca announced an outreach effort with two groups, one of them being the National Medical Association (NMA), which represents more than 50,000 African-American physicians. The NMA’s Project Increase Minority Participation and Awareness of Clinical Trials (IMPACT) maintains a database of African-American physicians committed to participate in clinical trials. (The other group, the Interamerican College of Physicians and Surgeons, which represented more than 39,000 Hispanic physicians, is defunct.)
Johnson & Johnson has reached out to the NMA and the National Hispanic Medical Association, which has more than 45,000 Hispanic physicians. Merck and Pfizer are among the biopharmas that have partnered with the NMQF.
What has been missing until now, Dr. Puckrein added, is a permanent network—a gap the NMQF and partners intend to address by creating the trial network. He said it will include registries of investigators and patients, plus community-level health statistics, to help investigators pinpoint minority populations that share a medical need and, when appropriate, facilitate their recruitment into clinical trials quickly and cost-efficiently.
“What we hope to be able to do at launch is to begin to make visible the number of investigators that are practicing in minority communities, who are available to clinical trials, as well as to encourage patients to volunteer for more trials. A lot of that is done around data, and making data accessible to the companies,” Dr. Puckrein said.
One potential point of confusion: The NMQF-PhRMA-Microsoft trial network, the National Clinical Trial Network, is distinct from the NCI’s broader trials improvement initiative, the National Clinical Trials Network. Not only do the two efforts have almost identical names, they also use the same acronym, NCTN. The NMQF-PhRMA-Microsoft trial network is focused on diversity. The NCI network is intended to streamline its array of support programs for cancer trials into a system that improves their design, innovation, speed, and efficiency. The NCI network follows a 2010 Institute of Medicine (IOM) report recommending that the NCI transform its clinical trials system, in part by broadening patient diversity.
Lilly-RCPI Effort to Augment Traditional Training
“The more investigators of color conduct clinical trials, the more likely minority patients are to participate in them, Alex A. Adjei, M.D., Ph.D., FACP, senior vice president for clinical research and director of the Center for Drug Development at the RCPI, told GEN.
“Lots of things can uniquely affect how a drug works in the population. From the pure scientific standpoint, if you have a drug that you’re going to use in a population that is not homogeneous, it would make sense that when you’re testing the drug, you test it in a heterogeneous group,” Dr. Adjei said.
Dr. Adjei will oversee the Lilly-RCPI workshops, which he said will be similar to courses he has conducted for junior investigators in Asia in 2011, and for oncologists from the Middle East last year. The Lilly-RCPI workshops are designed to teach minority investigators the principles of effective clinical trial design, provide them with tools for conducting relevant trials, guide them in identifying challenges, then educate them on overcoming those hurdles. Workshops will also provide ongoing mentorship to young minority investigators to help them build career-long relationships with faculty.
“If somebody wants to be a lab investigator, they go and work in somebody’s lab for a couple of years, establish themselves, and go on. But if you want to do clinical trials, there’s no formalized training,” Dr. Adjei said. “Traditionally, you’re training in a big place where they’re doing a lot of clinical trials, you take part in them, and you learn as you go. There are lots of minority physicians who are interested; they have the desire, but they don’t have the tools. The purpose of this workshop is to provide them with those tools.”
The workshops reflect a broadening of trial diversity efforts for Lilly. In 2011, it announced study results showing an increase from 19–43% in the percentage of minority patients for a non-small-cell lung cancer trial. The study credited measures including selecting trial sites likely to include more than 50% minority patient populations; providing patients with information regarding assistance programs; visits to trial sites aimed at eliminating barriers to minority participation; and, an obvious initiative, translating patient materials into Spanish.
The NCI’s NCORP Considers the Community Setting
Empowering minority patients and investigators in clinical trials is among NCORP’s goals. The initiative is designed to deliver clinical trials focused on cancer prevention, control, treatment, and imaging to patients in their own communities, led by investigators knowledgeable not only on cancer care delivery research, but on treatment disparities between minorities and the general population.
NCORP’s creation reflects the thinking that since much cancer care occurs in community settings, trials occurring there hold hope for more diversity among investigators. Dr. Puckrein estimates that about one-third of the nation’s trial investigators practice in zip codes where minorities comprise a majority.
Institutional issues were among the topics addressed at at “Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop,” an event held February 11 by the IOM and the American Society of Clinical Oncology (ASCO). According to a video clip on the IOM's website, Worta McCaskill-Stevens, M.D., M.S., chief of the Clinical Oncology Program and program director for the Minority-Based Community Clinical Oncology Program at the NCI’s Division of Cancer Prevention, said that the initiative “will accommodate those large institutions that serve minority and underserved populations, who will be charged to mentor other programs, and to bring to the table the scientific and intellectual resources to help reduce disparities.”
Greater opportunities for minority investigators to lead clinical trials are more likely to arise if various stakeholders act quickly to pool knowledge, then apply it. Many public and private efforts require consolidation. But the stakeholders—industry, academic, and other research institutions, providers, and government—have common needs, from saving money to improving data quality, rendering the present time optimal for diversifying clinical trials.
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