Why Add Research to Your Practice?
One business strategy physicians and medical groups often consider is adding clinical research to their practices. Clinical research offers several benefits: a) a new revenue stream; b) an opportunity to be recognized for and participate in cutting-edge research; c) the ability to provide additional options for your patients; and d) the chance to assist in the advancement of clinical research for future generations.
By adding clinical research to your private practice, you’ll be entering an industry that has invested more than $10 billion annually on clinical trial management in the United Sates.
- Become Informed
The first critical step is learning about the clinical research process and the business of conducting and managing a safe and ethical clinical study. There are several resources available, ranging from workshops, webinars, conferences and publications — e-newsletters, training guides, standard operating procedures — to specific LinkedIn Groups to join and network with clinical research professionals.
Additionally, study the Code of Federal Regulations (CFR) Title 21 and documents pertaining to the International Council for Harmonisation (ICH) to learn and understand the requirements for clinical trials and the specific forms needed to initiate a trial. Through CITI or another reputable resource, become certified in Good Clinical Practice (GCP), which defines practices that ensure the well-being and confidentiality of study subjects and covers the collection of reliable data for submissions to regulatory agencies.
- Build the Business Infrastructure
Clinical research is about helping today’s patients and future generations, and physicians can decide to run a trial site as a hobby or as a professional business. If the latter, it’s important to strategically establish the proper infrastructure — operations, financials, staff resources, technology, regulations, training and other critical components — to ensure the business is profitable and successful. A strong understanding of the patient recruitment and enrollment process is needed along with a grasp of the differences in government and private payer policies.
- Equip Your Practice’s Infrastructure
Clinical research requires specific skills and adds an additional workload to what may already be a busy practice. To achieve efficiency in conducting clinical research, develop standard operating procedures for your office; these will help ensure work is conducted in a consistent and timely manner. If you plan on performing clinical research on a continual basis, consider hiring an experienced study coordinator and other research team members. With this team in place, you can devote your time to oversee the medical aspects of a study while your staff coordinates trial activities as well as the adoption and implementation of new technologies to keep the operation running effectively and efficiently.
- Keep the Patient in Mind
Clinical studies succeed when research needs are balanced with the practicalities of delivering clinical care. Perhaps an even more important point is that studies show that patients who are actively involved in their health care achieve better health outcomes and have lower health costs than those who don’t. Talk to your patients about clinical research as you provide day-to-day medical care and oversight. Explain how participation may benefit them personally while it advances the cause of improving medical care around the world. Introducing conversations before you begin implementing clinical research to your practice may help you improve perceptions and boost future enrollment.
- Consider Partnering with Another Site to Reduce Overhead Costs
There are numerous advantages to joining a research site network with like-minded colleagues in your field. Technology, systems and training overlap, so leveraging these costs across multiple sites provides an economy of scale and financial advantage. In addition, a site network may offer a level of collaboration on business strategies, marketing and patient recruitment campaigns and may also share study lead opportunities and other strategies.
There are manifold benefits to implementing a clinical research capability in your private practice. Clinical research has been shown to benefit practices financially and can increase the well-being of patients through new and innovative treatment options. However, to ensure success, specific steps are needed to support clinical research while also allowing you to meet your business objectives.
Ready to maximize your site’s performance through an efficient clinical research site strategy? Read our case study.
Shalali Cassim, MS, PMP
Executive Director, Clinical and Site Operations
Experienced in all phases of site management, Shalali Cassim began her career as a project manager and over several years was promoted through a succession of positions, including enrollment manager, operations manager and senior manager of physician relations. As Frenova’s director of site services, she oversees staff and leads operational efforts to ensure orderly administration. Cassim earned a bachelor’s degree in global studies from the University of Minnesota and is currently pursuing a master’s degree in clinical research organization management from Drexel University College of Medicine.