ENTtoday

How to Incorporate Clinical Research Into Your Otolaryngology Practice

by Karen Appold •

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.

enttitalists as Test Subjects

You receive a study protocol and are invited to participate in a trial. Should you? Ask yourself these questions to help determine whether you should be a part of it as a principal investigator.

  1. Does the study ask a legitimate question? Does the study place participants at any significant risk?
  2. Do you or your associates have sufficient experience in the relevant area?
  3. Are you likely to encounter a sufficient number of patients who meet entry criteria to enroll in the study?
  4. Do you have the proper support staff to perform the intervention and appropriate follow-up and data submission?
  5. Are your facilities and ancillary equipment sufficient?
  6. Will the financial arrangements be sufficient to cover your costs? Is the reimbursement arrangement ethical? Are there any hidden costs that you might have to bear?
  7. Are you, the principal investigator, committed to seeing the project through?

Source: Lader EW, Cannon CP, Ohman EM, et al. Circulation. 2004;109:2672-2679.