Alliance supports the Clinical Trials Modernization Act

Clinical trials are essential in developing treatments that increase survival and improve the quality of life for people with colorectal and other cancers. Clinical trials are the bridge between research and cures, demonstrating both safety and efficacy.

Unfortunately, 20% of all approved clinical trials never start due to a lack of participation. Additionally, many trials struggle to recruit underrepresented groups, including racial minorities, older adults, rural residents, and those with low incomes.

To improve clinical trial participation, last month, Reps. Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduced the Clinical Trials Modernization Act (H.R. 8412). This bipartisan legislation would help remove four major barriers patients cite as reasons for non-participation:

1. Clinical trial expenses: These include both direct medical and non-medical costs. The medical portion is generally covered by the trial sponsor or insurer. Non-medical expenses include time away from work, transportation, lodging, and other out-of-pocket costs. Seventy percent of patients indicate they are more likely to enroll if out-of-pocket costs are covered. Despite guidance from the Food and Drug Administration, many trial sponsors do not help patients with these costs, citing concern that doing so violates federal restrictions on what constitutes a financial incentive to participate. The Clinical Trials Modernization Act would resolve this with statutory language.
2. Location of trials: Most clinical trials are conducted at major academic medical sites due to the specialized personnel and resources available. However, most patients are treated at community cancer centers, making trial participation difficult. Eighty percent of patients indicated they would be willing to use remote technologies. The Clinical Trials Modernization Act would allow trial sponsors to provide digital health technology at no cost to patients, enabling remote participation.
3. Diverse participation: Clinical trials must have diverse participation to prove safety and efficacy for a diverse population. The Clinical Trials Modernization Act would allow the Department of Health and Human Services (HHS) to issue grants supporting community outreach and recruitment for trials.
4. Financial implications: Patients receiving support for clinical trials may be subject to taxation or have it count against income limitations for safety net programs. The Clinical Trials Modernization Act would exempt this support from taxable income and limitations.

The Colorectal Cancer Alliance is advocating for the passage of the Clinical Trials Modernization Act because improving participation in clinical trials is vital if we are to bring new treatments for colorectal and other cancers. Please join us and let your representative know that finding new cancer treatments is important and that there should not be unnecessary barriers to clinical trials. Ask your representative to co-sponsor the Clinical Trials Modernization Act (H.R. 8412). You can find the address for your representative at www.house.gov.