Clinical research, when done correctly, provides a plethora of benefits to the researchers involved in the process as well as patients enrolled in the trials. Setting up a successful clinical trial process was the topic of a recent breakout session led by Daniel R. Saltzstein, MD and Lawrence Karsh, MD at the 2016 Large Urology Group Practice Association (LUGPA) Annual Meeting.
The two experts, as reported by OncLive.com, detailed several reasons why physicians should participate in clinical research. First and foremost, clinical research can contribute to the “greater good” of society by providing front-line therapies to patients in need at no cost. Karsh went on to explain the professional benefits clinical research provides as well: an ancillary revenue stream, increased number of publications, and credibility among the medical community. Karsh, who currently manages 35 trials that are either enrolling participants or ongoing, admits that he “think[s] it’s a huge bonus to learn how to use therapies before they even enter the market because it gives you the edge against other practices, [but] be clear that this won’t be a windfall and you can even lose money if it is not managed properly.”
Community physicians can be better strategic partners for pharmaceutical companies because they are able to “review proposals and contracts faster, recruit patients more rapidly, and offer an overall lower trial cost and greater diversity of [treatment states in their] patient base,” Saltzstein advises. Saltzstein and Karsh go on to list the vital positions for a successful clinical research program:
- Principal investigators
- Sub-investigators
- Director of research
- Study coordinators
- Data entry professional
- Recruiter and data miner to identify patients
Physical space within the clinic should not be forgotten either. Karsh suggests that “choosing space within eyeshot of referring doctors” helps keep the research program top of mind. Another key factor not to dismiss is earning buy-ins from colleagues. A coherent, well defined benefit statement of the program’s impact on patients and the clinic should be communicated to each participant. A prosperous program cannot be built overnight, as Karsh concludes that it “takes time and experience to start a research program – you will definitely go through some struggles… but the more trials you do, and do well, your name gets out and companies will come to you.”
For help from our experts at Pearl IRB on establishing or fine-tuning your clinical research program, please contact us to begin a conversation.