How to Incorporate Clinical Research Into Your Otolaryngology Practice

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.”