3 Quick Takes From A PI With 100+ Trials To His Name
A conversation with Norman B. Gaylis, MD, F.A.C.P., M.A.C.R., master rheumatologist and chief investigator, Arthritis & Rheumatic Disease Specialties
With more than 150 trials conducted, Norman B. Gaylis, MD, knows what it takes to run successful clinical trials. In this quick Q&A, Dr. Gaylis gives his 2 cents on patient recruitment, protocol design, and vendor selection from the site perspective.
Clinical Leader: What patient recruitment and retention strategies do you embrace that help improve enrollment and reduce dropouts?
Dr. Gaylis: During my 40 years of clinical research, the best patients we recruit are those we have established a relationship with. Usually, these are patients who have already tried conventional treatments that have not worked well enough or have not worked at all. When patients have already developed a relationship with their provider, there is an element of trust, and we can communicate with them that there are no guarantees regarding the research outcomes. Another important aspect of recruiting is not to recruit patients who are never going to be compliant or improve because they have complications, such as depression. We want study participants to be comfortable with the process rather than reluctant or hesitant. We believe it is much better to recruit patients organically or through word-of-mouth.
We improve enrollment and reduce dropouts by always being transparent about the benefits and potential pitfalls of participating in a study. We stress that patients will need to be compliant and come for all office visits and take all the tests in order to be successful. We have a good retention rate because we make sure each patient has a research coordinator who is available to them 24/7 via cell phone and can answer questions every step of the way. They offer reassurance regarding adverse events they may be experiencing and how to manage any adverse events, as well as arranging for patients to come to the office immediately if necessary or answering questions about taking medications or symptoms. Often, patients will develop strong relationships with research coordinators because they are constantly following up to check on them and make sure everything is going smoothly.
Which protocol design approaches best balance scientific rigor with patient experience?
At our Arthritic & Rheumatic Disease Specialties Clinic, we work with pharmaceutical companies to develop and fine-tune protocols that will be beneficial for all sides. We also develop our own research and protocols, and we design the protocol according to the properties of the drug and what is needed from the patient. For example, if the drug is an infusible, the protocol has to be designed to make it easy for the patient, with parking access and transportation, as well as familiarizing them with the staff. Having respect for the patient’s schedule and time is also important. We have to consider how often patients will need bloodwork or infusions to avoid multiple visits if possible.
Overall, the patient experience should be enhanced by providing patients with everything they need to be comfortable with the study. For example, some researchers pay patients for their time, while others may offer to reimburse transportation expenses. There are usually a lot of moving parts when designing a protocol, because if you design one that is too time-consuming or complicated for the patient, they will tend to drop out. Ideally, the priority should be what is best for the patient rather than what is best for the study.
How do you approach vendor selection for trial success?
We prefer to work with experienced CROs, particularly those we have worked with in the past. For CROS, one of the challenges is finding research sites that operate according to industry standards and can do what is required. For us, it’s best to choose a reputable vendor rather than wasting money and finding out later that the arrangement is not going to work.
What we have learned over time is never take a study if you do not have the specific patient population you need. If most of your patients are seniors, you will have a difficult time accepting a study concentrating on Gen Z patients.
Another thing that has helped us with trial success is following up with patients after the study is completed. We think it is crucial to explain that because most studies are blinded, they cannot be sure of the dosages they are receiving or if they are getting a placebo. We help them understand that at some point, they will be switched over to the real medicine, if approved by regulators, and they will be able to get the treatment . We don’t believe in leaving the patient to wonder what is happening once the study has concluded. Once the study is concluded, subject to FDA criteria and the sponsor, we always try to share the results of the study as well as the medication the patient was receiving.
About The Expert:
Norman B. Gaylis MD, F.A.C.P., M.A.C.R., is a leader in arthritis and related diseases and is a practicing rheumatologist based in Miami, FL. Dr. Gaylis is active with the American College of Rheumatology (ACR) and is currently a member of their board. In 2015, he established the Norman B. Gaylis, MD Research Award for rheumatologists in community practice. In 2017, he received Master of the American College of Rheumatology designation, the highest honor that the College bestows on its members. Dr. Gaylis is involved in clinical trials studying treatments for rheumatic diseases and has been a principal investigator in over 150 new pharmaceutical products. Dr. Gaylis is a medical graduate of the University of Witwatersrand, Johannesburg, South Africa, and he completed his residency in internal medicine and fellowship in rheumatology in Miami. He is the chief operating officer of Arthritis & Rheumatic Disease Specialties, AARDS Research, Inc., and the Infusion & Immunotherapy Center of South Florida (IIC).