Many physicians and health care providers are intrigued by clinical research and seek out to become Principal Investigators (PI) without knowing what that role entails. While future PIs may have advanced medical degrees and specialised training, they are often unfamiliar with what is involved in overseeing a clinical trial or the regulatory responsibilities that are needed for their role.
Many physicians and healthcare providers are intrigued by clinical research and seek out to become Principal Investigators (PI) without knowing what that role entails. While future PIs may have advanced medical degrees and specialised training, they are often unfamiliar with what is involved in overseeing a clinical trial or the regulatory responsibilities that are needed for their role.
Given the importance of physicians in determining appropriate care options, it is imperative that the industry do more to educate and enable physicians to access clinical research trials for their patients. This article aims to share best training practices and explain why improving patient access to clinical trials starts at home by developing more physicians to become clinical research investigators.
PIs play an vital role clinical research. They are responsible for all clinical research-related activities at their site and act as the bridge between the research and physician practice communities. PIs play an integral role in the conduct and management of the study. Unfortunately, there is a shortage of high-quality sites available for sponsors for certain indications and in certain parts of the world. Approximately 50 per cent of principal investigators who participate in a clinical trial for the first time do not participate again1, citing complexity of trials as the main reason, as well as lack of training and support, according to the Tufts Center for the Study of Drug Development’s analysis of data from the U.S. Food and Drug Administration2.
The high PI turnover rate raises concerns, and some sponsors hesitate to use inexperienced PIs since they help determine the success of a study. With experience often comes operational efficiencies in site selection, study start-up, enrolment, and data collection, among other things. These efficiencies help reduce trials costs and expedite timelines, which is why it is important to address the barriers that lead to “one-and-done” participation syndrome.
When surveyed, PIs cited lack of time, lack of resources, inadequate research experience, trial-specific issues, existing clinical management duties as reasons for not participating in clinical research3. While participating in research, PIs are expected to recruit by discussing trial participation with his or her patient base and assist with the screening process. PIs will conduct study-specific visits and take part in regulatory and monitoring visits. In combination with these barriers, complex protocols can create undue stress. Much of this stress can be alleviated with practical, advanced clinical research training, coaching and support to healthcare practitioners, enabling them to experience the many benefits of clinical research.
Adding high-performing research sites through adequate PI training broadens the pool of patients potentially eligible for trials and address the industry challenge of site and patient access for pharmaceutical and biotech companies developing promising new therapies. Training more healthcare providers to conduct clinical research will give patients greater access to trials closer to home which makes trials more convenient and enables more patients to participate, including patients from traditionally underrepresented populations. This in turn enhances clinical trial diversity, making studies more representative of the real-world patient population and reducing failure rates.
Clinical research offers patients access to cutting-edge therapy, increased quality of care, closer medical attention, better follow-up, and continuity of care. If physicians with practices in rural areas participate in clinical research, their communities' benefit from expanded access to healthcare options. Physicians active in clinical research can expand their knowledge base and help develop medical innovations. Clinical research creates an additional revenue stream for sites, too. Research also helps hospitals and educational institutes with additional funding and grant capacity.
To increase participation, the research community needs to clearly outline the benefits of clinical research and potential to improve patient care. To make clinical research more accessible as well as encourage research culture, it is necessary to supply PIs the support they need to enhance their probability of being successful in taking part in clinical research. One way to do this is through advanced training tailored to the needs of the investigative site and staff and ongoing coaching designed to encourage repeat site participation. Providing mentorship programmes and peer programmes helps build a support system amongst research physicians.
The first step in setting up PIs for success is to correctly train new-to-research sites the right way from the very beginning to provide quality data. Effective training drives repeat participation by physicians and healthcare providers in clinical trials by equipping them with the knowledge, skills, and desire to perform successfully.
A robust training programme can develop and upskill workforce capabilities across the clinical research industry, ease CRO burden by improving site capability to deliver quality outputs, promote career expansion and development, and bring clinical trials closer to the patients who need them. Training with spiral learning – an approach founded on the premise that students acquire a greater understanding of a subject each time the topic is met -- exposes learners to a wide variety of concepts and topics while deepening the complexity. Spiral progression, anchored by experiential based learning achieved through the real-life scenarios and interactive activities, builds confidence by providing real and practical experience.
Training should be detailed enough to address multiple learning styles and include the role specific ACRP (Association Clinical Research Professionals) core competencies for clinical site staff, aligned to the current Good Clinical Practices guidelines. To meet the demand of training needs, it is beneficial to implement a train-the-trainer approach. This will allow experienced clinical staff with an interest in training, to expand their area of focus, influence their own career development plan and boost motivation whilst sharing their expertise with the sites. The inclusion of multi-lingual staff in this approach provides opportunity for the training to be delivered in other languages, expanding the global reach and accessibility for PIs.
Training performed at crucial intervals between site qualification and activation, before the study, during the study and after the study provides a full continuum of support for learning. An easyto- use program that includes multiple tools and comprehensive training at each critical stage of the clinical trial process will increase engagement with healthcare providers. Offering flexible training delivery via virtual, face-to-face, or combined training sessions as needed allow PIs the opportunity to make trainings work with hectic schedules. User-friendly features such as an intuitive online interface to support the trainee, a learner community portal offering resources and tools, a learner forum and mobile gaming increase learner retention and encourage repeat site participation in trials. Also, ongoing coaching in certain key areas like audits and inspections, study protocol review, statistics or risk-based monitoring helps keep momentum and support.
Given the current clinical trial landscape, it is more important than ever to expand the pool of clinical research sites. The most effective method to do this is to engage these physicians in a robust, targeted, just-in-time training program that bridges the gap between medical practice and clinical research. Ongoing support is also key to reinforce key concepts and knowledge throughout the life of the trial with user-friendly tools and process templates. By applying this methodology, using a program like PPD’s SiteCoach, hopefully we can increase repeat site participation and move away from the 'one and done’ pattern currently observed.
1. Gertz KA, Lamberti MJ. Global site landscape remains highly fragmented with variable performance. Tufts Center for the Study of Drug Development Impact Report. March/April 2013;15
2. Wilkinson M, Getz K. Tufts CSDD Study Highlights: End-to-End Site Identification Through Start-up. April 2017
3. Rahman, S., Majumder, M. A., Shaban, S. F., Rahman, N., Ahmed, M., Abdulrahman, K. B., & D'Souza, U. J. (2011). Physician participation in clinical research and trials: issues and approaches. Advances in medical education and practice, 2, 85–93. https://doi.org/10.2147/AMEP.S14103