AACR Calls to Up Federal Research Funding 7%, Improve Regulatory Science Behind Personalized Medicine

Enhanced federal investment in cancer research is necessary, according to the new report Cancer Progress Report 2015: Transforming Lives Through Personalized Medicine from the American Association for Cancer Research (AACR).

The report, released Sept. 16, serves to both educate the American public and further AACR's advocacy efforts in Congress. It highlights the progress made in the last year towards improving cancer care and calls for increased funding for "robust, sustained" budgetary increases of at least 7 percent for the National Institutes of Health (NIH), National Cancer Institute (NCI), and U.S. Food and Drug Administration (FDA) in fiscal year 2016 and thereafter to further future advances.

Among the progress cited in the past year is the FDA approval of nine new anticancer therapeutics and new uses for six previously approved anticancer therapeutics, including four targeted therapies, as well as one new cancer-screening test. AACR says that the number of FDA-approved molecularly targeted anticancer therapeutics more than doubled in the past five years, reaching 52 as of July 31, further cementing a role for molecular diagnostics in the future of cancer care.

"During the past five years, the pace of progress against cancer has accelerated dramatically," the report authors write. "As the research landscape has changed, the regulatory and clinical trial landscapes have adapted to keep pace." AACR credits the FDA for advancing regulatory science in supporting the use of genomics and adaptive clinical trial designs, which identify the patients most likely to benefit from a given therapy. It is hoped these emerging trial strategies will reduce the number of patients required to enroll in a trial to demonstrate a therapy's effectiveness and trim the costs associated with conducting trials. In turn, it is hoped these new trial designs can accelerate the pace anticancer therapeutics enter clinical use.

In addition to innovative trial design, the FDA has developed four evidence-based strategies to expedite the evaluation of therapeutics for life-threatening diseases, including cancer. AACR says that breakthrough therapy designation was awarded to 26 anticancer therapeutics as of July 31, 2015, and nine of these therapeutics have received FDA approvals after receiving this designation.

AACR sees the FDA as an "integral part" of the biomedical research community and believes that adequate funding is imperative for the agency to keep pace with the rapid progress in biomedical research.

"The revolution in cancer research can be meaningful for patients only if the regulatory bodies that approve the resultant novel therapies adapt as the research landscape changes," the report claims. "The regulatory science initiatives of the FDA are aimed at promoting and developing evidence-based regulatory policies that balance innovation and the expedited approval of medical products with patient safety."

The AACR report highlights the importance of molecular diagnostic testing in cancer care and calls for expanded FDA regulation of laboratory-developed tests saying that a "single, predictable, risk-based regulatory framework implemented by the FDA to evaluate diagnostic tests will not only safeguard patients, but it will also further advance precision medicine."

AACR research shows that current funding for biomedical research and its subsequent regulation is inadequate and proposes "robust, sustained, and predictable" funding increases for the FDA and health-related granting agencies. The Biomedical Research and Development Price Index (BRDPI) incorporates the rising cost of personnel, supplies, and equipment required to conduct biomedical research. AACR says that since 2004 the NIH budget has fallen behind BRDPI and has lost approximately 25 percent of its ability to fund research. This, combined with "budget stagnation" for NIH and NCI since 2003 has resulted in a decline in research grant awards, which reached the "lowest 'success rates' on record" in 2014—a one in seven chance of obtaining NCI funding.

Takeaway: Given the FDA's recent advances in regulating tests and therapies associated with personalized cancer care, and the potential future regulation of laboratory-developed tests, AACR calls for ongoing increases in funding for the FDA and health-related federal granting agencies.