By Matthew Roe, M.D., Duke Clinical Research Institute (DCRI); Kaitlin Malone, Amgen; and Gerrit Hamre, Clinical Trials Transformation Initiative (CTTI)
Leading a clinical trial at a research site as an investigator is a challenging task. Running a successful study requires the ability to manage budgets, coordinate the activities of support teams, efficiently allocate limited time and resources, and navigate the complexities of regulations and reporting obligations.
Lately, there has been growing concern that these challenges are leading to a shrinking pool of experienced site investigators. A 2015 Tufts survey found that roughly half of the world’s clinical investigators in 2013 were relatively inexperienced first-time trialists, and turnover rates even among experienced investigators appear to be growing.1 More recently, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA), reviewed information housed in the FDA’s Bioresearch Monitoring Information Systems (BMIS) database that suggests attrition rates may be especially high for U.S.-based site investigators. Taken together, these developments have serious implications, because the success of U.S. clinical research depends on a healthy supply of experienced, knowledgeable site investigators and support staff.
In response to these concerning trends, CTTI created the Investigator Community Project to examine factors that contribute to investigators deciding to leave or remain engaged in research and identify opportunities for strengthening and supporting the community of site investigators and their staff.
Why Are Investigators Leaving Research?
To get a clearer picture of the challenges facing site investigators, CTTI conducted a series of interviews and surveys to explore what it saw as the most significant barriers to staying engaged in clinical research. “One-and-done” investigators — that is, those who stopped participating after just one trial — consistently described four key issues as the most significant barriers to their continued engagement in clinical trials:
However, more than 40 percent of “one-and-done” investigators indicated that they were still interested in participating in clinical trials, but had a hard time finding appropriate trials after their initial trial experience.2
CTTI also interviewed investigators who had been involved with multiple clinical trials to identify attributes that might contribute to sustained participation as a site investigator. These “stayer” investigators consistently invoked personal commitment, institutional support, and experienced, well-trained staff as being particularly important to their ongoing participation in clinical trials.
Strengthening The Investigator Community
Based on these findings, as well as a consensus that emerged from a multi-stakeholder expert meeting convened to tackle the problem of investigator turnover, CTTI developed a set of Recommendations for Strengthening the Investigator Site Community. Below, we list these major recommendations and describe some of the actions that should be considered by investigators, sites, health systems, sponsors, and CROs to support and grow the community of site investigators:
Putting Recommendations Into Practice
As site investigators and stakeholders for clinical trials put these recommendations into practice, it’s important to realize that many can build on existing programs or initiatives. For instance, many CROs already have programs in place to recognize the contributions of site investigators and staff; such programs can be reviewed for opportunities for improvement or expansion. Similarly, the use of streamlined approaches to study start-up has been gaining traction in recent years; leveraging these efforts by providing additional education in best practices for invoicing and capturing study milestones can make processes more efficient and expedite payment — both of which will benefit sites. Finally, sponsors, CROs, physicians, and medical schools can all play roles in providing training, mentoring, and a career path for physicians interested in site-based clinical research.
Building For The Future
Aligning training, communication, and infrastructure in ways that sustain and support investigators and study staff, while at the same time anticipating and reducing logistical and organizational burdens, will help create a more welcoming, sustainable, and efficient environment for conducting clinical research. As these approaches are implemented, it will be essential to continue to gather insights into challenges facing investigators and seek evidence-based, collaborative solutions that ensure the long-term health of U.S. clinical research.
About The Authors:
Matthew T. Roe, M.D., is a cardiologist with extensive experience as principal investigator in numerous phase II-IV cardiovascular clinical trials. He has also served in leadership roles for observational registries focusing on patients with acute myocardial infarction, patients undergoing percutaneous coronary intervention, and patients with familial hyperlipidemia. Dr. Roe is the DCRI Fellowship Program Director and served as faculty director of the Global Megatrials group at the DCRI from 2013 to 2017. He is the co-principal investigator of the ADAPTABLE trial (the first, large-scale pragmatic trial being conducted in the PCORnet network). He has published over 400 articles in high-tier journals.
Kaitlin Malone has been with Amgen over a decade and is currently a clinical trial oversight manager within Amgen’s Global Study Operations team with oversight of the clinical trial contracts, budgets, and payments. While she is located at Amgen’s headquarters in Thousand Oaks, CA, Kaitlin also supports global teams with the development of training tools and support resources to ensure consistency and quality. She has enjoyed partnering with CTTI on the Investigator Community initiative since 2016. Malone holds a bachelor’s degree in law and sociology from the University of California, Santa Barbara.
Gerrit Hamre manages the development and implementation of CTTI projects. In collaboration with team leaders, he creates project plans and budgets, and manages the implementation of project plans. Prior to joining CTTI, he worked in the U.S. Food and Drug Administration’s (FDA) Office of Legislation, followed by the FDA’s Center for Drug Evaluation and Research, Office of Policy for Pharmaceutical Quality. His primary areas of focus at the FDA were the drug approval process, antibacterial drug development, manufacturing quality, and generic drugs. Before joining the FDA, Gerrit worked on pharmaceutical science or healthcare delivery administration issues in corporate, federal government and non-government organization (NGO) sectors, domestically and internationally.