SU2C has developed the procurement language to solicit proposals for SU2C Dream Teams, Research Teams and other grants mechanisms in the SU2C research portfolio to increase diverse participation in cancer clinical trials.
Grant applicants submitted to SU2C will now need to include the following information:
- An indication of whether the research will address the populations expected to benefit from widespread use of newly developed treatments;
- Patient recruitment and retention plans for including historically underrepresented racial and ethnic populations—such as the need for additional trial sites or mechanisms to reduce barriers to access; and
- A letter of support from the lead institution’s chief diversity of ficer, or an equivalent position.
These changes, announced at SU2C’s Scientific Summit Jan. 27, will also be considered in SU2C’s selection process, and as part of grant performance evaluation conducted in SU2C’s formal semi-annual reviews.
In U.S. cancer clinical trials in 2018, 4% of participants were black or African American, 4% were Hispanic, and 15% were Asian, according to data from FDA.
“We’re looking for a positive way for grantors to show a specific plan of how they’re going to recruit and retain minority populations in clinical trials,” John Whyte, SU2C committee member and chief medical of ficer of WebMD, said to The Cancer Letter. “FDA requirements say you should create a plan as to how you’re going to recruit minority populations, but no one focuses as much on retaining them as well.”
In addition to changing grantmaking requirements, SU2C plans to provide up to $6.4 million for the SU2C Health Equity Breakthroughs Research Team that will focus on cancers af fecting underrepresented populations, supported by a transformational grant from Genentech, a member of the Roche Group.
SU2C said it will issue the request for applications seeking proposals later in the first quarter of 2020. Proposals may address cancers that have a higher prevalence in a specific racial or ethnic population; cancers that are more deadly among specific minority populations; or may address the need for more ef fective treatments for specific cancers for patients of diverse backgrounds.
“As one of the leading funders of cancer research, we believe it is our duty to ensure that minority representation in cancer clinical trials is addressed. Now, more than ever, better understanding of the role of biology in cancer treatment, advances in precision treatment, and development of new technologies demands that we also make significant improvements in diverse clinical trial participation,” SU2C CEO Sung Poblete said in a statement.
The SU2C Health Equity Breakthroughs Research Team will be selected and launched in 2020.
“This research will need to be supported by directed funding towards these problems,” John D. Carpten, professor and chair of Translational Genomics, director of the Institute of Translational Genomics at Keck School of Medicine at the University of Southern California and SU2C committee member, said to The Cancer Letter.
“The SU2C initiative uses the incentive of its substantial funding for research teams to ensure those projects plan for recruitment and retention of diverse patients in its SU2C-supported clinical trials across all cancers studied. And those plans become benchmarks to assess performance in rigorous semi-annual in-person reviews,” Carpten said.
Low accrual andretention of minorities
Overall, minority groups in the U.S. have higher death rates and shortest survival rates for most cancers. Clinical trials that don’t include minority participants, or include very few, can result in evidence that isn’t applicable to minority populations.
The opportunity to take part in clinical trials is viewed as a matter of both science and addressing health disparities. Moveover, the stakes have grown higher as cutting-edge treatments are increasingly producing better outcomes for patients.
“There has been tremendous progress made in precision medicine ef forts in the past decade, but these new and innovative treatments may not work for all patients,” Edith A. Perez, chair of SU2C committee for health equity in cancer clinical trials and Serene M. and Frances C. Durling Professor of Medicine at Mayo Clinic College of Medicine, said to The Cancer Letter.
“We need more people from diverse ethnicities and backgrounds to participate in translational clinical trials. In order to find and develop treatments that work for a broader group of patients, we need to be more inclusive of traditionally underrepresented groups in trials and cancer research in general,” Perez said.
PCORI funds Project TEACH
As part of a larger initiative to increase diversity in cancer clinical trials, three groups—the Black Women’s Health Imperative, Friends of Cancer Research and SU2C—received funding to support Project TEACH, which aims to increase participation of black women in cancer clinical trials through education and outreach.
The collaboration is funded through the Eugene Washington PCORI Engagement Awards program, an initiative of the Patient-Centered Outcomes Research Institute.
“Ultimately, the goal is to have this army of black women who are informed about the clinical research process, what’s involved, who can then help other women engage in that process to get the best possible outcomes,” Linda Goler Blount, president and CEO of the Black Women’s Health Imperative, said to The Cancer Letter.
For instance, when the United States Preventive Services Task Force made the recommendation for women to receive a mammography starting at the age of 50—they did so based on data that has lower representation of black women, who are historically more at risk of triple-negative breast cancer, among others, Goler Blount said.
According to USPSTF, breast cancer screening guidelines in the U.S. are largely based on trials and cohort studies that were performed in Europe and predominantly enrolled white women younger than age 70. This means that direct evidence about any dif ferential ef fectiveness of breast cancer screening is lacking for important subgroups of women, such as African American women, who are at increased risk for dying of breast cancer.
Having more black women in clinical research would help answer vital scientific questions “so that we can be sure that the so called evidence that comes out of the studies is actually applicable to them,” Goler Blount said.
BWHI is the lead organization on Project TEACH. The collaboration will use Friends’ Progress for Patients tool to help black women involved in the project to understand the drug development process and what’s involved, Goler Blount said.
“We’re looking to use Progress for Patients as a model of success that we’ve seen and adapt that to specifically address how black women would learn, and what black women need to know within the clinical trials process—to get them more comfortable with clinical trials, to get them more aware of clinical trials,” Ryan Hohman, vice president of public af fairs at Friends, said to The Cancer Letter.
Ultimately, the goal is to integrate Progress for Patients into Project TEACH—to “create an ecosystem where you have educated patients who are empowered—and not only interested in a clinical trial themselves—but who can talk to their communities and be a proponent for clinical trials,” Hohman said
Gastric cancer research team
At the summit, SU2C also introduced the new international SU2C Gastric Cancer Interception Research Team. The team includes investigators from Harvard Medical School and Massachusetts General Hospital Cancer Center; University of Pennsylvania’s Perelman School of Medicine; University of Chicago; City of Hope Comprehensive Cancer Center; Memorial Sloan Kettering Cancer Center and Samsung Medical Center in South Korea.
Gastric cancer is more common in black, Hispanic, and Asian people than in white populations. This $3 million research team is conducting intensive studies to identify biomarkers and cells shed from the tumor that circulate in the blood system and indicate the presence of gastric cancer.
Team members have developed a detection technology, extending the use of a pill-sized camera that can be swallowed by the patient using a new marker to light up cancer cells, allowing the camera to capture images of stomach tissue at risk of developing cancer. If validated in a clinical trial, these methods will help doctors screen people in groups at risk of gastric cancer.
“By having Research Teams dedicated to cancers that correlate to, or greatly af fect, dif ferent racial and ethnic populations, we’ll be able to ensure that strides are being made in cancers that typically af fect these populations,” Perez said. “Support for these teams further demonstrates our commitment to bringing breakthrough therapies to historically underrepresented racial and ethnic groups and improving overall health equity in cancer research. We are proud and excited to play such a large role in serving this unmet need and look forward to setting the tone for scientific research to come.”