Public Policy Resources

Restrictive eligibility criteria are the second leading cause preventing patients from enrolling in cancer clinical trials.  FDA recently issued draft guidance encouraging trial sponsors to use a science-based approach that would allow a wider variety of patients to participate in cancer clinical trials.

Over 80 organizations are urging Congress to take up and pass reform to modernize the oversight of diagnostic test. 

For oncology biomarkers, commercial payers uniformly cover companion diagnostics because clinical utility is established as a component of FDA review (there is typically a therapeutic agent that is approved in parallel).

This bill would modernize and harmonize oversight of in-vitro diagnostic tests, and ACS CAN provided feedback to draft legislative language.  The feedback addressed core issues of interest to patients.

Over 50 individuals convened over the course of two days to develop recommendations that would improve the ability of patient-facing cancer clinical trial matching services to help patients find suitable clinical trials.  The summit resulted in nine consensus recommendations focused on improving cliincal trial databases, integration of electronic medical records, and better understanding how tools may be integrated into small practice settings. 

Clinical trials are pivotal to advancements in cancer treatment, but patient enrollment in these trials remains a challenge. Clinical trial matching services facilitate patient enrollment in clinical trials by identifying potential trials for interested patients and their proxies (e.g., caregivers and providers), and in some cases by providing other support services such as educational materials or personnel who can answer questions or assist patients.

Leading health care companies and organizations representing patients, providers, laboratories and diagnostic manufacturers called on Senate and House leaders to advance legislation that would reform and modernize the process for bringing innovative diagnostics and clinical laboratory tests to market.

The objective of cancer research is to generate new knowledge that can be used to improve survival and quality of life for patients with cancer. Clinical trials are the key step in advancing potential new cancer treatments from the research setting to the cancer care clinic, and patient participation in trials is crucial to this success.

ACS CAN supports the coverage of FDA-approved NGS panels, and also supports the coverage of panels used as part of NCI clinical trials.  CMS is encouraged to reconsider limitations on patient eligibility and is urged to create clear and achievable requirments for evidence development.