Clinical trials save lives. They offer access to new medical treatments to patients who have exhausted all other options.

The trouble is that not all patients have the same opportunity to participate in a clinical trial in the United States.

Earlier this month, a world champion triathlete, representatives from UCHealth and The Leukemia & Lymphoma Society, visited members of Congress in Washington, D.C., to advocate for House Bill H.R. 3503 – NIH Clinical Trial Diversity Act 2023. The bill would improve access to clinical trials for all. Currently, patients living in rural communities, young adults, older patients and people of color are especially underrepresented in trials.

Siri Lindley, a world-class triathlete, best-selling author, life coach and motivational speaker, is fortunate that she was near an academic medical center – UCHealth University of Colorado Hospital on the Anschutz Medical Campus – and able to participate in clinical trials. Diagnosed with Acute Myeloid Leukemia (AML) in 2019, she was given a less than 10% chance of survival at the time of her diagnosis. She participated in two clinical trials, and her doctors declared her cancer-free in 2020.

Lindley shares her personal journey in an upcoming UCHealth documentary: “Tri Me – The Siri Lindley story.’’

“I am one of the lucky ones,” Lindley says in the documentary film about her journey.

The National Institutes of Health is the largest funder of clinical trials, investing nearly $3 billion annually in biomedical and behavioral research, including trials. The NIH Clinical Trial Diversity Act would help increase diversity in NIH-funded trials. The legislation would increase trial diversity by:

• Promoting accountability for enrollment diversity. The Act requires NIH and clinical trial investigators to develop clear and measurable recruitment and retention goals based on disease/condition prevalence.
• Reducing barriers that keep patients from participating in trials. The Act promotes trial protocols that make care available closer to a patient’s home. It also promotes less burdensome follow-up care, as well as greater use of technology in follow-up care. Examples may include fewer required follow-up visits, allowing phone participation in certain aspects of the trial and making treatment available during weekend hours.

Many patients who now participate in clinical trials are those who live close to an academic medical center. But not all patients can afford to travel to a trial site or take time off from work to travel. They might not have access to transportation or be able to afford lodging. Many have difficulty navigating insurance coverage if the trial site is out-of-network.

UCHealth physicians Dr. Dan Pollyea and Dr. Jonathan Gutman, both professors and researchers at the University of Colorado School of Medicine, managed Lindley’s care. At the time of her diagnosis, participation in a clinical trial was her best chance for survival. Had she not had the means and the support network to participate in the clinical trials, her outcome may not have been as favorable.

Pollyea told her about a clinical trial using venetoclax and azacitidine, targeted cancer drugs, to achieve remission. She also enrolled in a clinical trial to receive a life-saving bone marrow transplant using a match donor and an umbilical cord donor.

Lindley says in the documentary, “I was told the other day that typically with AML, you can be diagnosed one day and dead in five weeks. … I get diagnosed, and everyone’s rallying around me and saying, OK, you need to get on this clinical trial, and we’re getting things started right away, and literally right away, they started treating me.

“If I didn’t have that access, the insurance, my family, my mom, my wife that could drive me back and forth to the hospital every day, would I have been gone in five weeks?”

Well-known in the triathlete community, Lindley finished last in her first triathlon race but went on to become a two-time world champion. She’s a member of the Triathlete Hall of Fame and a winner of 12 ITU World Cup races. She is the author of Surfacing: From the Depths of Self-Doubt to Winning Big and Living Fearlessly and one of Tony Robbins’ top 10 motivational speakers.

The Leukemia & Lymphoma Society and UCHealth are addressing the urgent need for better trial access. UCHealth has a patient-assistance fund and partnerships with various community organizations to help offset some of these costs for clinical trial participants, but it often doesn’t cover all of the expenses associated with the current in-person care requirements for clinical trial participation.

LLS addresses the need for better access through advocacy efforts and LLS IMPACT Research Grants, which are awarded to major cancer centers to create a network of clinical trial sites to assist patients. Through its Clinical Trial Support Center, LLS’s experienced clinical nurse navigators provide free, personalized assistance to patients throughout the entire clinical trial process.

Patients who participate in clinical trials not only have the potential to help themselves, but they can also help others with similar conditions; advances in the treatment of cancers with poor historical outcomes can come only through widespread participation in clinical trials.

Introduced by Rep. Robin Kelly, D-Illinois; and co-sponsored by representatives nationwide, including Rep. Brittany Pettersen, D-Colorado, and Rep. Joe Neguse, D-Colorado, the clinical trials bill proposes groundbreaking changes, including expanding tele- and virtual-health options and allowing for some follow-up care to be administered locally by patients’ primary care physicians.

Community members can visit the LLS website for ways to show their support for H.R. 3503.