How to Form A Clinical Research Team

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So, you’ve decided to conduct clinical research in your practice.

In the January issue of ENTtoday, we reviewed what to expect when you embark on this undertaking as a principal investigator (PI), including determining what to study, developing a protocol, navigating the red tape to get your trial off the ground, and collecting data to publish (“Incorporating Clinical Research into Your Practice,” cover).

In this article, we cover two additional critical components of conducting clinical research: forming a research team to assist you and enrolling patients.

The Team

Your research team may include a combination of co-investigators, a clinical research coordinator (CRC), a clinical coordinator, and a statistician or methodologist. “Your needs will depend on the type and size of the project, the infrastructure already available in your practice, and how much time you can devote to the project,” said Julie Strychowsky, BHSc (Hons), MD, a clinical fellow in pediatric otolaryngology at Boston Children’s Hospital. Multidisciplinary or multicenter collaborations can also provide a wider breadth of expertise.

Plan on contacting at least twice as many patients as you think you will need. Unless the study is looking at a rare disease or an intervention where none existed previously, where a higher percentage of patients may be interested in research, many patients will not choose to participate.

—Judith E. C. Lieu, MD, MSPH

Here’s a look at the responsibilities of each role.

Co-investigators. These key personnel work closely with the PI in all aspects of the study. “While the PI is ultimately responsible to conduct the research project, a co-investigator is also obligated to ensure that the project is conducted in compliance with applicable laws, regulations, and institutional policy governing the conduct of sponsored research,” said Shaun A. Nguyen, MD, MA, CPI, associate professor and director of clinical research in the department of otolaryngology–head and neck surgery at the Medical University of South Carolina in Charleston. Co-investigators may include healthcare providers with separate areas of expertise, such as other MDs or PhDs, audiologists, or speech-language pathologists, and would be expected to be an author for any presentations or publications that arise from the research.

Clinical research coordinator. This specialized professional ensures uninterrupted and ethical conduct of a clinical trial. “Although the PI is largely responsible for proper conduct of a clinical study, the CRC shares the onus by working in coordination with the PI under his or her supervision,” said Dr. Nguyen, who has conducted research in the areas of general otolaryngology, head and neck cancer, laryngology, rhinology, otology, and pediatric otolaryngology. The CRC acts as an intermediary among trial participants, the institution, and sponsors on ethical, personal, and financial aspects of the trial.