Clinical trials are the key step for getting new and innovative cancer treatments to patients that will improve survival and quality of life. Once the Food and Drug Administration (FDA) determines that a new treatment is safe, the company (sponsor) is required to conduct a clinical trial, which is an extensive test of the treatment in a large number of patients to demonstrate that it is effective. A new treatment will not be available to patients generally until the clinical trial is completed, then reviewed and approved by the FDA.
For companies conducting clinical trials, recruiting the necessary number and type of patients is a major challenge. In fact, one out of every five clinical trials for cancer treatments fail simply because they are not able to recruit the necessary number of patients. Cost is one of the barriers to participation in clinical trials. Participation in a clinical trial involves both medical and other non-medical expenses. Typically, either the patient’s health insurer or the trial sponsor covers the treatment expenses, but patients have other costs such as transportation and time away from work. Patients earning less than $50,000 are 30% less likely to participate in a clinical trial.
Patients with lower income are not the only group underrepresented in clinical trials. Certain racial and ethnic groups, older adults, children, and rural residents are also significantly underrepresented in clinical trials. These recruitment challenges result in trials failing to appropriately reflect the diversity of the patient population. The trials take significantly longer to make new treatments available; and in some cases, the treatment is never approved if the trial fails to reach the required number of patients.
With the goal of reducing these barriers to participation in clinical trials, the bipartisan DIVERSE Trials Act has been introduced in both the House and Senate. The Act would make it easier and safer for sponsors to provide patients with financial support for the costs they incur participating in the trial. Sponsors are often concerned about violating federal research participant protections if they provide monetary support. The Act would ensure sponsors are protected.
The Act allows sponsors to provide technology enabling remote participation. This will aid participation from rural areas and reduce the need for travel expenses.
Importantly, the Act will require the Department of Health and Human Services (HHS) to develop guidance on ways to conduct clinical trails with greater demographic diversity.
The Colorectal Cancer Alliance supports The DIVERSE Trials Act, as does the American Cancer Society and other cancer groups. The Senate bill (S. 2706) was introduced by Senator Menendez (D-NJ). The current co-sponsors are Senators Booker (D-NJ), Braun (R – IN), Padilla (D-CA), Scott (R-SC) and Smith (D-MN). The House bill (H.R. 5030) has but two sponsors, Rep Ruiz (D-CA) and Rep Bucshon (R-IN).
We should not delay in getting new cancer treatments to patients or lose them completely due to problems recruiting clinical trial participants. Please call or send an email to your senators and representative asking that they cosponsor The DIVERSE Trial Act. You can find contact information at Congress.gov.
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