Part 2 in a 2 part series
The practice of dermatology offers many avenues to expand one’s professional horizons and skills. One such area of sub-specialization is clinical research, namely pharmaceutical company-sponsored clinical trials. This article continues the discussion of some of the steps that a willing and interested physician can take to get involved with clinical trials.
1. Prepare yourself and your practice
One cannot simply start performing clinical trials without preparing oneself or one’s practice. Familiarize yourself with requirements and train one of your nurses or assistants to be a Research Coordinator. Performing clinical trials requires knowledge of Federal Codes and Regulations such as Good Clinical Practices (GCPs), areas of locked cabinets for drug storage, temperature regulation and monitoring, and space for specialized equipment. There will be initial an investment of time and capital that will only pay off with proper preparation.
2. Perform
Once one is selected to participate in a clinical trial, they should plan on recruiting effectively. This not only means getting the right number of patients in a timely fashion, but getting quality patients and providing quality data is critical to one’s success and obtaining future trials.
3. Be innovative
Always think about and evaluate the product under study. Is there any additional information that the company should be obtaining that they are not? Is there something about the product that would make it suitable for another disease state? Would you be willing to perform an Investigator Initiated Trial on this or another product for this company? These are all questions that you can be asking yourself and the company during the course of a study that increases your value as an investigator.
If all of the above still seems interesting and not daunting, then it is possible that clinical trials will be a good fit for your practice. Go for it and best of luck!
