Getting started with prospective research studies during residency training
Q&A with resident and researcher Ajax Yang
Research can be a daunting task to add onto a busy residency or fellowship training schedule. Cases, retrospective studies, and review articles use existing data and require little to no involvement of an institutional review board (IRB), and thus can yield a manuscript faster than prospective studies. However, with early planning and design, serving as an investigator on prospective trials is certainly possible during training. I sat down with Ajax Yang, MD, who recently launched an IRB-approved trial to study the effects of cryotherapy versus lidocaine on neuroma-associated pain, to discuss starting a study as a resident.
GM: How did you become involved in research at Mount Sinai?
AY: The thought of conducting scholarly activities while juggling clinical and personal responsibilities during residency, on the surface, can be intimidating, let alone running IRB-approved prospective studies. However, in reality, anyone with a genuine curiosity can transform what traditionally is seen as an arduous activity into something that is extremely rewarding and invigorating.
I am fortunate that my mentors are very knowledgeable and encouraging, and my wife is very understanding and supportive. My advice to anyone interested in conducting research during residency is to speak to faculty and peers. It is also helpful to stay open-minded to the type of research to gain experience — case reports and review articles are a great entry point into the research process, and one can readily apply his/her experiences to another project.
GM: How should one approach the design of a prospective study?
AY: Identify what question you want to answer. Pilot studies commonly evaluate the safety and tolerability of a treatment and are faster and easier to complete than trials testing efficacy (which require enough subjects for sufficient statistical power). Minimize the sample size (N) by minimizing the number of test variables and thus the number of control groups. The study duration and costs are both functions of your sample size (N), and they increase with N.
GM: Speaking of costs, how is the study funded?
AY: It actually is unfunded; our department provides the lidocaine and supplies and a device company supplies the cryotherapy needles. So, you do not always need a grant to get started. Though if I did have funding, I would try to cover patient travel expenses — a known recruitment booster in the New York City area.
GM: How much time do you commit to research projects?
AY: It is difficult to estimate. Depending on the demand of each rotation, I try to designate two hours every day during which I am reading or writing. I often think about research projects while commuting or exercising; this step helps later when putting ideas on paper. Some days, I can sit in front of my computer for hours unable to come up with cohesive thoughts. It is for all the times that I struggle with writing that make the days when my ideas flow, and I type away effortlessly that much sweeter.
GM: How many people are on your project team?
AY: Two people currently. The frequency of study visits per week is low enough that the principal investigator and I can handle the procedures and data collection during each study visit. I recommend collaboration with peers if you are just starting out and unsure how much responsibility you are able to take on.
GM: How are you recruiting subjects?
AY: Word of mouth — I advertise the study to my colleagues in rehabilitation and other departments, because they are most likely to know potential subjects. I use paper flyers and electronic brochures to be included in emails and electronic newsletters (e.g. New York Spinal Cord Injury Association). Listing the study on ClinicalTrials.gov (an FDA requirement) not only increases study visibility to potential subjects but also facilitates networking with other investigators nationwide who share similar interests.
GM: Finally, how long do you expect the whole study to run?
AY: We are on target for the goal of 23 subjects completing the study by 2017, so I am optimistic about finishing a manuscript by the end of the 2018 academic year.
Dr. Yang and Dr. Marzloff are PGY-3 residents in the Department of Rehabilitation Medicine at Icahn School of Medicine at Mount Sinai.
Dr. Yang is an investigator on the following studies:
- “Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton’s Neuroma” https://clinicaltrials.gov/ct2/show/NCT02838758
- “Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury” https://clinicaltrials.gov/ct2/show/NCT02736890
