From the Deputy Director for Intramural Research

Transparency in Clinical Research: Improving Safety and Quality by Working in Partnership

BY MICHAEL GOTTESMAN, DDIR; ANDREW GRIFFITH, BRUCE BURNETT, AND VALERIE BONHAM

Clinical research is a team effort. The team includes patients and other research volunteers, our colleagues on institutional review boards (IRBs), agencies such as the Food and Drug Administration (FDA), Congress and other public and private entities that support the work that we do, and the broader public. Without all members of the team working together, we cannot accomplish our mission to improve the lives of those we serve.

Teamwork requires clear and effective communication among all members of the team. For many years, NIH has been charting new ground to expand access to information about clinical research and research results. In September, a series of reforms were announced to further these goals and ensure that NIH-funded research meets the highest performance standards. These policies, known generally as the “NIH Clinical Trial Stewardship Reforms,” include requirements that all NIH-funded clinical trials, including Intramural Research Program (IRP) activities, must register and report results at ClinicalTrials.gov, a public database maintained by the National Library of Medicine.

Increased transparency on clinical-trial availability, enrollment criteria, and outcome measures and results, both positive and negative, will strengthen the design of future trials, deepen public understanding of the work we do, and reduce the possibility that patients and other volunteers will be exposed to unnecessary risk.

Another important advance will be the development of a new electronic system to collect information about NIH’s entire intramural clinical-trial portfolio. Once completed, this initiative will enable better monitoring and a more comprehensive analysis of intramural clinical research. This comprehensive database will protect the integrity of our science and the safety of the research participants.

The newly formed Office of Research Support and Compliance (ORSC) within the Office of Intramural Research is working to improve communication among our team members by facilitating the access and sharing of information across the IRP. As a central office, ORSC is positioned as both a service provider and an expert resource for all researchers and research programs within the IRP. It will serve as a nexus to collect, aggregate, and compare data about IRP clinical-research activities. Through data review, the ORSC will enable us to detect trends and gaps so that we can accurately and efficiently target training and other resources to improve safety and quality.

For example, we recently learned about troubling delays in reporting serious adverse events (SAEs) and unanticipated problems (UPs)—to the IRB, study sponsor, and FDA—in an NCI-sponsored and -conducted phase I study. SAEs and UPs often occur in clinical research, especially when patients are seriously ill. To learn effectively from these situations and to ensure patient safety, it is absolutely required that SAEs and UPs be reported in a timely manner.

Intramural investigators across NIH have now been asked to audit their clinical-research studies and especially their reporting of SAEs and UPs. When this data collection is complete, the ORSC will help us to understand and correct possible weak points or misunderstandings in reporting duties in specific programs or for specific types of events. This is a forward-looking effort to raise our oversight of clinical research to even higher levels.

The ORSC is also reaching out to all NIH IRBs to identify and understand instances of delayed reporting of UPs and SAEs to the IRBs. The ORSC will also use an experienced contractor to initiate a detailed audit of a sample of clinical protocols in all NIH institutes and centers (ICs), focusing on protocols that are regulated by the FDA. This audit is expected to begin early next year. The ORSC will work closely with the Office of Human Subjects Research Protection, the NIH IRBs, and IC compliance staff and leadership. The office welcomes and encourages comments from investigators and other staff across the IRP. It is an important first step toward our goal of clear communication among the entire team.

Another important component of our goal to reach the highest levels of clinical care in the Clinical Center is the ongoing series of discussion groups involving members of our patient-care staff. The groups are facilitated by Stewart Simonson, who is a lawyer dedicated to public-health issues and a former director of emergency preparedness in the Department of Health and Human Services. More than 500 staff members are participating in these meetings, which include frank discussions of areas in which NIH clinical care, already of high quality, can be further improved. These discussions will inform practice in the Clinical Center and the discussions will be communicated to NIH staff through a regular newsletter.

The ORSC can be contacted directly by e-mailing or calling Acting Director Bruce Burnett or Deputy Director Valerie Bonham or by e-mailing orsccontact@mail.nih.gov. To report concerns or issues anonymously, you may call the NIH Clinical Center Anonymous Safety Hotline at 1-866-444-8811.

Our first responsibility is always the safety and compassionate care of all our patients and NIH research volunteers. They are the most important members of our clinical-research team. As with all successful teams, all of us need to communicate freely and clearly to achieve our goals of advancing foundational knowledge and improving the lives of the people we serve.

Andrew Griffith is the scientific director for the National Institute of Deafness and Other Communications Disorders and the deputy director for Intramural Clinical Research; Bruce Burnett is the acting director of ORSC; and Valerie Bonham is the deputy director of ORSC. To read more about the “NIH Clinical Trial Stewardship Reforms,” go to https://www.nih.gov/news-events/summary-hhs-nih-initiatives-enhance-availability-clinical-trial-information.