Explore this issue:January 2015
With the growing number of new drugs, devices, and treatment strategies, opportunities for practicing physicians to get involved in medical research are increasing rapidly. Otolaryngologists in private practice may be attracted to the idea of serving as principal investigators or investigators in clinical research because they want to be part of something that advances the specialty, to be a co-author of a peer-reviewed manuscript, and to have the opportunity to increase their credibility or market their clinical career.
Such a task shouldn’t be taken lightly, however. While the outcome can be very rewarding for the investigator, patients, and society at large, navigating the red tape, enrolling patients, and conducting the trial itself can be challenging and time intensive. Knowing what to expect up front may help you determine whether becoming a principal investigator is indeed a path you should embark on.
What to Study
Clinical trials pool controlled observations scientifically and objectively. Data reveal what drugs, devices, and treatment strategies work best. As more new offerings proliferate in the marketplace, more trials are necessary.
Choosing a topic shouldn’t be rocket science. Select a subject that you are both interested in and passionate about. “Most of your time spent on research will be above and beyond your clinical responsibilities,” said Julie Strychowsky, BHSc (Hons), MD, a clinical fellow in pediatric otolaryngology at Boston Children’s Hospital. “If you’re interested, you will stay motivated.”
An idea may stem from an interesting patient, controversies in the evaluation of his or her management, or unanswered questions. “When you come across one such case, speak with your colleagues and review the literature,” said Dr. Strychowsky, whose research has revolved around evidence-based practice, systematic reviews and meta-analyses, and outcomes-based research in pediatric otolaryngology. “Where are the current gaps? How could you help to close those gaps? Staying up to date will ensure that your research is clinically relevant and novel.” You may also generate ideas by attending meetings. Learn about what studies are currently underway at clinicaltrials.gov.
Envision your career 10 years from now. Where do you see yourself professionally? “Align your projects and research interests with these goals,” Dr. Strychowsky recommended. “At times, you may start a project that seems to fizzle out from either a lack of support or interest, or other unforeseen constraints. Accept it and move on.”
First Things First
After developing your protocol, and before beginning your research, you’ll need to address some regulatory and compliance issues. You’ll need approval from an institutional review board (IRB) (also known as an independent ethics committee or ethical review board) to perform your study. This committee approves, monitors, and reviews research involving human participants to protect patient rights and safety, with guidelines set forth by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). You’ll have to complete consent forms that delineate the risks, benefits, and alternatives as well as the potential positive benefits of your research to patients and society. An IRB has the authority to approve or disapprove research, and can require modifications to study protocols.