Improved Design, Access, and Transparency of Trials Essential for Success of Cancer Moonshot

The National Cancer Institute (NCI)’s Cancer Moonshot initiative received yet another boost following Vice President Joe Biden’s announcement of several activities to accelerate the pace of oncology clinical research. The announcement, which comes less than 2 weeks after the Blue Ribbon Panel made its recommendations to the National Cancer Advisory Board, will hopefully improve participation in clinical trials, irrespective of where the trial is being conducted.

"These steps will improve the safety, accessibility and impact of our clinical research system" to help researchers around the globe develop new strategies against cancer, Biden said. The following are some of the announcements:

1. Redesign of cancer clinical trial information made available by the NCI

A collaboration between the NCI and the White House Presidential Innovation Fellows has resulted in a new user-friendly cancer clinical trial website, trials.cancer.gov, which provides information on NCI-supported trials. The website provides a new application programming interface (API), that allows researchers and patient groups to tailor information from the site in real time to identify relevant ongoing trials. The API is expected to ease new patient recruitment and ensure easy access to patients looking for information on trials to participate in.

2. FDA to announce efforts for new clinical trial designs

A series of efforts to garner the collective input from researchers across government and private industry will be announce by the FDA, to allow design of smarter and efficient trials. Tactics include sharing control groups across studies that use different drugs for the same indication and smarter patient selection. This can accelerate the pace of studies, control costs, and help bring products to market faster for increased access.

In a recent blog post, Richard Pazdur, MD, acting director of The Oncology Center of Excellence launched in mid-summer, wrote that the FDA would like to move away from the traditional phase-based trials, to create a more seamless development process for drugs that would expedite the regulatory pathway and allow early access for drugs with good, validated outcomes. This, Pazdur wrote, would complement the FDA’s expedited processes such as breakthrough designation and accelerated approval.

3. HHS announcement of final rule for clinical trial registration and results reporting

HHS will release a final rule on requirements for clinical trial registration and reporting of trial results on the ClinicalTrials.gov website. This is expected to improve transparency and streamline access to trial information for all products (drugs and devices) that are yet to be FDA approved. On one hand, detailed access to such information will let patients make informed decisions on participation in a trial, and, on the other hand, it will prevent duplication of unsafe or unnecessary trials.

4. Increasing usability of ClinicalTrials.gov

To make ClinicalTrials.gov more user friendly and accessible, the National Institutes of Health is working with technical experts, counterparts of the Presidential Innovation Fellows. The objective is to make it easier for patients to research and identify interventions and clinical trials that would be relevant for their cancers.