We Are All Part of the Cancer Moonshot: Vice President Biden on Why Everyone’s Participation in Clinical Trials Matters

by Lyric Jorgenson, Deputy Executive Director, White House Cancer Moonshot Task Force

Currently, 31% of trials registered with ClinicalTrials.gov are recruiting for cancer-related conditions. Source: https://clinicaltrials.gov/, August 2016.

Transforming a breakthrough research discovery (or a series of discoveries!) into better and safer options for patients is the mission of the clinical research enterprise. Clinical trials, the cornerstone of clinical research, are key in this process and are key to any new strategy for defeating cancer. For instance, clinical trials helped bring about new cancer prevention strategies through the human papillomavirus (HPV) vaccine, new cancer biomarkers to identify cancer in its early stages and predict how aggressive it might be, and new treatments like cancer immunotherapies harnessing the power of precision medicine.

But efforts like these rely on the willingness of the everyday American to volunteer to help move an idea from bench to bedside. In some instances, she is a healthy volunteer and in other instances she is a patient looking to help find a cure for her illness. For some seriously ill patients, an investigational therapy being tested in a clinical trial offers a last option for hope. Thus, it is imperative that we work together to make sure that patients, caregivers, physicians, researchers, and the public have access to information about clinical trials, and that information gained from the contributions of those who volunteer results in better care for patients.

Under the Cancer Moonshot, Vice President Biden is working across the government and private sector to make strengthening the U.S. clinical research system a national priority. In a series of efforts announced today, we are moving closer to our goals of maximizing opportunities to participate in clinical trials, valuing participants’ contributions while minimizing risks to their health, and ensuring that that results of these trials are used to make rapid and significant gains in the fight against cancer.

And here’s how we’re doing it.

First, we are trying to make it easier for people to find information about cancer clinical trials. In a new partnership between the White House Presidential Innovation Fellows (PIFs) and the National Cancer Institute (NCI) of the National Institutes of Health (NIH), we redesigned how people find information about cancer clinical trials at trials.cancer.gov. We also released a new user-friendly application programming interface (API) so that researchers and patient groups can easily access data on NCI-supported clinical trials and tailor tools and resources to help people find the trials that are right for them.

Next, we are trying to design smarter clinical trials to accelerate the process of delivering safe and effective treatments to patients. The Food and Drug Administration (FDA) will launch a series of efforts to bring together clinical researchers across government and private industry to design more efficient clinical trials that produce robust results. Better trials that produce better results bring new therapies to patients for less money and in less time.

Third, we are making sure that information about clinical trial studies and their results are shared. Today, the Department of Health and Human Services released a final rule that specifies the requirements for clinical trial registration and summary results information reporting to ClinicalTrials.gov, a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The NIH is also announcing a series of efforts accompanying the rule to improve the quality and efficiency of clinical research. Access to this information will ultimately help people find trials, enhance clinical trial design, prevent unnecessary duplication of unsuccessful or unsafe trials, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research.

Importantly, to expand on the final rule and policy for clinical trial registration and summary results reporting, NIH is committed to make ClinicalTrials.gov a more user friendly and accessible site. As such, it is working with technical experts at 18F, the Presidential Innovation Fellow’s counterparts, to explore ways in which a partnership between the two could accelerate these efforts.

Efforts to make information about clinical trials more accessible– whether it lets a patient know which study is recruiting for his condition or a doctor know which new treatment offers the most promising results — represents a seismic culture shift essential for the success of the Cancer Moonshot. These efforts, combined with smarter and more efficient clinical trials, usher in a new era of ensuring that clinical trials result in safe and effective therapies delivered to the public as quickly as possible.

Lyric is the Deputy Executive Director of the Cancer Moonshot Task Force. She joins the team from her position as the Deputy Director for the Office of Science Policy at the National Institutes of Health (NIH). Lyric has been in the director’s office at NIH for the past 8 years, developing policies and creating strategic initiatives pertaining to biomedical research and public health.