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.
You may want to contact an IRB analyst to explain your idea and use his or her expertise to guide the development of your research plan and documentation, said Timothy Smith, MD, MPH, director of the Oregon Sinus Center at the Oregon Health and Science University in Portland, whose own clinical trials have focused on the management of chronic rhinosinusitis.
Be sure to report any potential conflicts of interest to the IRB. This could occur if a pharmaceutical company is paying you to conduct the trial or a company is compensating you to try a new device or therapy. Ask the IRB if disclosure is sufficient or if you need to divest yourself from certain interests before moving forward. In such a situation, you should not be involved in the recruitment or consent phase of the study.
In addition to getting IRB approval, you’ll need to comply with Health Insurance Portability and Accountability Act (HIPPA) regulations. Furthermore, a clinical trial must be regulated by a governing agency, such as the NIH, a clinical trial agency, and so forth, said Maie A. St. John, MD, PhD, associate professor in the department of head and neck surgery and co-director of the University of California Los Angeles Head and Neck Cancer Program, Jonsson Comprehensive Cancer Center.
The FDA enforces laws and regulations and is one of multiple bodies that can regulate research. “The FDA is quite accessible,” said Dr. St. John, whose research has focused on head and neck cancer. “It is often most convenient, efficient, and straightforward to set up a call or Webinar in which you prepare a PowerPoint presentation outlining your proposal.”
Learn which agencies you will need approval from by consulting CenterWatch, the NIH, or cooperative groups such as Eastern Cooperative Oncology Group, SWOG cancer research group, or Radiation Therapy Oncology Group, or contact a local academic institution.
Getting Published
After you have collected data, performed the analysis, and perhaps submitted an abstract for presentation at a meeting, it’s time to publish your findings in a scientific journal. Consider your intended audience to determine the best journal for publication. This may be an otolaryngology publication or one with a broader scope. “See where similar articles have been published,” Dr. Strychowsky suggested. “Consider this decision at the start of your writing process so that you can prepare your manuscript in the format specific for the intended journal.”
One of the largest barriers to getting research published is completing the manuscript. “You just need to sit down and write it,” Dr. Strychowsky said. “Set mini milestones for deadlines, and finish your paper.”
Don’t get discouraged if your manuscript is rejected. Take note of the reviewer’s comments and use them to strengthen your manuscript for your next submission.
Dr. Smith estimates that otolaryngology journals have between a 20% and 60% acceptance rate for manuscripts that are submitted once a project is completed. “This is because not every idea is feasible or of interest in the world of clinical medicine,” Dr. Smith said.
If you’re looking to patent an idea, contact a patent attorney or patent firm. You’ll have to disclose details about why your idea is novel and patentable. After submission, you may be asked to make modifications or provide further details.
Being involved in clinical research can be rewarding both professionally and personally; however, you must be prepared in order for your trial to succeed. Part 2 of this discussion, which will publish in an upcoming issue of ENTtoday, will take a look at the clinical trial process itself—including information on how to calculate research costs, assemble a research team, and enroll patients.
Karen Appold is a medical writer based in Pennsylvania.