SUO 2019: Overview of Clinical Research Process and Clinical Trials Structure
Dr. Shore started his talk by outlining a researcher’s life cycle as four phases- embryonic (just starting)- who is building qualifications and skills to become a serious researcher, toddler (early on in career)- who is trying to subspecialize and focus on your interests, adolescent (quasi-independent)- who is establishing presentation skills and a body of work in peer-reviewed journals, and a research adult-who is pushing boundaries of science and clinical practice to improve patient outcomes directly.
Dr. Shore then highlighted vital characteristics necessary for a robust research enterprise, which includes a refined research vision, multi-disciplinary team, leadership, infrastructure, strong support and commitment, personal/professional opportunity to curate relationships, and camaraderie. As an investigator, it is essential to choose studies carefully and to identify functional research studies from poorly designed studies. Evaluation of statistical analysis and experimental design should be at the core of an investigator’s ideology. Building expertise and reputation in areas of interest may be advantageous. It is also crucial to consider the financial impact of the research to the center because the remuneration will support the research enterprise, but this should be balanced with patient care needs. Realistically balancing the current capabilities and capacities of the staff will prevent overstretching of available resources. It is imperative to acknowledge and report the mistakes when they happen and be prepared for audits. Legal compliance review of the clinical trial agreement is also essential, especially in academic centers, where the legal compliance team approves all contracts.
Dr. Shore then stressed on the importance of persistence for successful clinician-scientist and understanding the personal and professional commitment by managing expectations in personal life. Thorough knowledge of science is essential, and research operations must interface with practice clinical operations. This includes establishing referrals and ensuring that research becomes an integral part of the continuum of clinical services for patients at all stages of the disease and progression. Involvement in a clinical trial also involves comfort in navigating political, financial, and operational areas. A researcher’s career path also requires an honest self-assessment for risk tolerance, but interest in the advancement of science reaps immense rewards. Dr. Shore then talked about the importance of the need for innovation in the practice, research, and organization, and pointed that research is a delicate balance of the art, science, and business of medicine.
Dr. Shore concluded his talk by thanking his mentors and summarizing the programs available for researchers searching for resources through LUGPA and AUA. He also highlighted his journey having built reputation nationally and internationally at the Carolina Urology Research Center, which is not based in a traditional major metropolitan population center but has successfully conducted 400 clinical trials. He also talked about available consortium for research for large private practice groups such as the CUSP. He concluded his overview by providing a reference to the LUGPA practice manual and AUA update paper on how to conduct research in community practice.
Presented by: Neal Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, South Carolina
Written by: Abhishek Srivastava, MD, Society of Urologic Oncology Fellow, Fox Chase Cancer Center, Fox Chase Cancer Center, Philadelphia, Pennsylvania, @shekabhishek at the 20th Annual Meeting of the Society of Urologic Oncology (SUO), December 4 - 6, 2019, Washington, DC