Cancer Moonshot Report Highlights Strategic Goals
President Obama’s “Cancer Moonshot” initiative has released a task force report on implementation plans. One strategic goal, it says, is to catalyze new scientific breakthroughs by “fostering interdisciplinary approaches for elucidating the biological mechanisms underlying cancer onset and treatment; aligning research and care as a seamless and iterative process; and maximizing the collection and research use of longitudinal data and biospecimens.”
Another strategic goal aims to unleash the Power of Data, according to the report. It would do this by enabling a “seamless data environment for clinical and research data through shared policies and technologies; unlocking scientific advances through open publication and storage platforms and next‐generation computer architectures; and developing a scientific workforce capable of using the open and connected data environment.”
And another goal seeks to accelerate bringing new therapies to patients. The report says this will be achieved by “finding efficiencies in the regulatory review and licensing processes; enhancing data sharing across sectors and incentivizing pre-competitive collaborations; and strengthening the oncology clinical research enterprise.” NIH is also collaborating with 12 biopharmaceutical companies, multiple research foundations, and philanthropies to develop a new program called Partnership for Accelerating Cancer Therapies (PACT). “PACT will fund pre-competitive cancer research and share broadly all data generated for further research, ultimately bringing more new therapies to patients in less time,” it says. “Potential initial focus areas include understanding responses to cancer therapies, clinical trial platforms for combination therapies, predictive modeling approaches, and therapies for rare cancers.”
Additionally, the reports calls on FDA to modernize eligibility criteria for clinical trials. “FDA will evaluate clinical trial entrance criteria that may unnecessarily restrict clinical trial access — such as brain metastases, HIV status, organ dysfunction, and age restrictions (e.g., pediatrics) — to better assess when restrictions are warranted for specific clinical trials to protect patient safety,” the report says. “Safely removing certain exclusion criteria and broadening eligibility criteria would render the results of clinical trials more generalizable to the actual patients who will receive drugs in clinical practice and provide patients with access to promising new drugs. Moving forward, FDA will work with sponsors to improve the use of science‐based, clinically relevant eligibility criteria to allow greater patient access to clinical trials while maintaining patient safety. This project is currently underway and should be completed over the next one to two years.”