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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.
Additional responsibilities may include identifying eligible patients, scheduling and escorting patients from different venues, obtaining informed consent from patients, performing tests, entering data into a database, verifying data integrity, performing basic statistics, and helping to prepare presentations and assist with article writing. In addition, the CRC may be charged with compliance to Institutional Review Board (IRB)-approved research protocols and applicable federal, state, and local laws and regulations. They must complete all required human research training and, if applicable, training required by the Health Insurance Portability and Accountability Act.
Clinical coordinator. While this position may have some overlap with the research coordinator, the clinical coordinator tends to have some medical training, either as a nurse or physician assistant. Additional skills allow this research assistant to perform more studies on patients.
Statistician or methodologist. This team member will ensure that the PI develops a methodologically sound protocol that is appropriately powered to answer the primary research question. Usually possessing a master’s or PhD level of training in biostatistics, this person has expertise in research methodology, helps to analyze the data, and is integral to the design and execution of the study as well as evaluating the integrity of the study after it is finished. The PI or a co-investigator can often handle this function.
Patient Recruitment
Recruitment is 80% to 90% of the work in a clinical study. Your own patient population (or that of your co-investigators) is a great resource. “Plan on contacting at least twice as many patients as you think you will need,” said Judith E. C. Lieu, MD, MSPH, associate professor of otolaryngology-head and neck surgery and residency program director at Washington University in St. Louis School of Medicine. “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. Patients are free to participate or not and have the option of changing their mind and not completing a study. Even when they are excited about participating, the logistics can be an obstacle.”
It is important to let patients know that participation in research projects is voluntary. “Let patients know that they will continue to receive the same access to medical care whether or not they choose to participate and that they may withdraw from participation at any point,” said Dr. Strychowsky, whose research has revolved around evidence-based practice, systematic reviews and meta-analyses, and outcomes-based research in pediatric otolaryngology.
Try to provide an incentive, whether it is a gift card or a free assessment that comes from the research. If additional hospital or clinic visits are needed, consider reimbursing travel or parking expenses.
Enrolling Patients
Ask your research assistant to meet with patients who agree to enroll. This professional should be friendly and good at explaining things and answering patients’ questions. You can also have the research assistant obtain informed consent from patients.
The IRB for each institution will have specific guidance regarding informed consent, which includes these steps:
- Participant is briefed on what the study involves in language that is easy for a patient to understand;
- Participant is informed of the possible risks and benefits of the treatment;
- Participant is told about the risks and benefits of other options, including not undergoing treatment;
- Participant has the chance to ask questions and get them answered to his or her satisfaction; and
- Participant has time to discuss the plan with family members or advisors.
If the patient is a minor, has a serious mental disability, or cannot give consent, then the parent, legal guardian, or a person authorized by the court must give consent before treatment can start, Dr. Nguyen said. This is usually a close family member who has reason to know what the patient would want.
Follow the rules for research explicitly. “It’s better for patients to know up front what they are agreeing to do, rather than to be surprised when they are asked to sign the form,” said Dr. Lieu.
Conducting a clinical trial is a huge undertaking. Make sure you have a team of dedicated assistants in place to ensure a smooth process and that you follow all of the requirements when enrolling patients to ensure a successful research experience.
Karen Appold is a freelance medical writer based in Pennsylvania.