The old adage that “The practice of medicine is an art…” is attributed to Dr. (Sir) William Osler, one of the founding professors of John Hopkins University. While the merits of this observation have been widely debated, it is for certain that the practice of clinical conduct is firmly rooted in the scientific. The majority of physicians are introduced to clinical research while in medical school. The cross over from treating patients in a private practice or hospital setting to a clinical research one is theoretically, not a difficult transition for a medical professional to make. The difficulty arises with all the other aspects of clinical trials that must be tackled. Currently, there is a shortage of PIs in the pharmaceutical industry. Data indicates that many physicians engage in a single study and then decline further involvement. Why do physicians enter clinical research, navigate critical processes, and what are ways to support their continued engagement in the field?
GuideStar Research conducted a survey of several dozen physicians in 2018. The top five reasons these physicians cited for conducting clinical research included:
- 32 % to be involved in “cutting edge” therapies
- 28% to generate added revenue
- 20% to expand treatment options for patients
- 12% to attract new patients
- 8% to differentiate themselves
Physicians who serve as PIs are often recognized as thought leaders within the professional community. In some instances, these lead to opportunities to become co-authors of articles slated for publication in well-known and respected industry journals.
The barriers physicians face to entering clinical research include:
- Lack of trials in line with their interests
- Contracting and budgeting challenges
- Challenges with IRB (Institutional Review Board)
- Insufficient staffing
- Insufficient financial resources
- Time constraints
When queried, physicians cited the best ways to support physicians entering clinical research as:
- Assistance with understanding trial activation processes
- Research fundamental education and training
- Assistance of an experienced CRC (clinical research coordinator)
- Peer networking
- Trial specific training
Physicians also cited challenges in bridging clinical care and clinical research. The greatest challenge cited was how clinical care commitments limit the ability to focus on clinical research. Another issue is finding qualified staff that have dual clinical care/clinical research experience. Keeping clinical care in alignment with study protocol is also difficult. The most popular strategies to counter these issues are developing an incentivization program for staff and outsourcing administrative functions.
Five tips for more successful physician engagement are:
- Sites can focus on finding the right physician for the given clinical trial. It’s useful to provide information on the trial itself as well as on the site’s goals and organization. On approach is to host an informational “lunch and learn” presentation that included site particulars including experience, reputation, support staff, pharma clients, treatments in the pipeline, industry trends and competition, job expectations, compensation and study budgets.
- Outline expectations by having consistent meetings with the doctor and staff members at the clinic, review what can delay start up, review protocols and feasibilities, explain what can delay sponsor funding, share the patient recruitment plan, detail HIPAA compliancy and outline compensation.
- Review compensation models. Compensation for the PI can be based on a set percentage of overall study revenue, a per-procedure based PI/SubI compensation model or a fixed PI compensation model. There are pros and cons to each approach. For more information, contact a GuideStar Research specialist.
- A new physician may consider starting as a Sub-I and then transition to PI duties after a three to six-month pilot period.
- Communicate the benefits and gratifying aspects of offering studies to patients.
GuideStar experts bring a wealth of industry knowledge to your organization and help you incorporate clinical trial strategies to ensure financial and compliance best practices so you can focus on supporting patients. GuideStar’s talented clinical research professionals deliver expertise to optimize finance, operations, infrastructure, staffing, quality, compliance and strategy.