Experts Provide Tips on Setting Up a Successful Community-Based Clinical Trials Program

Daniel R. Saltzstein, MD

Clinical research in private practice is thriving and the future is bright, according to Daniel R. Saltzstein, MD, and Lawrence Karsh, MD. “Clinical research allows practitioners to positively impact their community and patient care while advancing their careers and generating revenue,” said Karsh. The pair gave pointers for setting up a clinical trial program during a breakout session at the 2016 Large Urology Group Practice Association (LUGPA) Annual Meeting.

Physicians have many possible reasons to participate in clinical research, Karsh said. He cited benefits such as ensuring that patients have access to cutting-edge therapies at no additional cost, and contributing to society’s greater good.

But there are also practice-related reasons for doing so, said Karsh, director of clinical research at The Urology Center of Colorado in Denver. Researchers receive an ancillary revenue stream, build their professional stature, and increase the odds of being published in scientific journals. “Research ‘feeds the beast’ by attracting new patients to your site and ensuring utilization of your in-house labs and imaging facilities,” he said.

Karsh speaks from experience. He has 20 trials that are currently enrolling participants plus 15 more trials that are ongoing. “I think 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,” he said. “Be clear that this won’t be a windfall and you can even lose money if it is not managed properly. But we’re getting market rates for all we do, not Medicare or negotiated rates.”

According to Saltzstein, director of clinical research at Urology San Antonio, community physicians make attractive partners to pharmaceutical companies. “When they deal with academic medical centers, they often encounter slow review of proposals, delays in enrollment and start dates, competing priorities, and a lack of urgency,” he said. “Community physicians 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.”

Both Karsh and Saltzstein emphasize that clinical research in private practice is not an endeavor to be taken lightly. “Your medical director of research absolutely needs to be a dedicated, enthusiastic, type A individual who will champion this cause throughout the practice,” Karsh said.

Additionally, principal investigators are also needed. “I used to be the principal investigator for all my trials, but [it had] gotten to be too much. I’ve been able to delegate to some young, talented colleagues who share my enthusiasm,” Saltzstein noted.

Sub-investigators are also necessary. These can either be physicians or advanced practice providers, Karsh said.

Having a director of research is also vital to achieving success. This person will deal with sponsors, institutional review boards, and the contract research organization hired by the manufacturer. He/she will also handle budgets and accounting, and determine appropriate staffing levels for each trial.

Then there are the study coordinators, whom Karsh and Saltzstein refer to as “the most important component of any study.” These people need appropriate qualifications and credentials. They could be nurses, though Karsh and Saltzstein have both had very good experiences treating study coordinator positions as career pathways for talented medical assistants. They must be utterly competent, trustworthy, and reliable, the presenters said.

Other staffing needs include personnel to perform data entry quickly and accurately, as well as recruiters and data miners to help identify appropriate patients for each trial. Nurse practitioners also keep trials rolling smoothly by conducting physical exams on prospective and current trial enrollees.

Physical space can also present a challenge to would-be researchers. “Ideally, you can dedicate space specifically to research, to keep things running well and signal to your entire practice that research is important,” Saltzstein said. “In my practice, we’ve gone from one exam room up to 3300 ft2 dedicated solely to clinical research.”

Karsh added that this research space needs to be located within the clinic. He went so far as to suggest that choosing space within eyeshot of referring doctors helps keep the research program front and center for them, too.

In fact, one of the key challenges will be earning buy-ins from colleagues. The presenters suggested spelling out the benefits of research participation to them, their patients and the practice. “There are clever ways to ensure your doctors are participating and thinking about these trials. I like to hand out laminated cards within the practice that highlight a couple of our studies at a time so it doesn’t become overwhelming,” Saltzstein said. “I target the appropriate doctors for each study based on their clinical interests.”

Saltzstein has gotten the best results from involving his entire staff, including call center employees, marketing employees, medical assistants, and surgical schedulers. “Ironically, you want minimal doctor involvement in the recruiting process because they have too many other things to think about.”

Karsh reminded attendees that trial accrual comes down to numbers. “Each trial has so many requirements that a realistic rate would be accruing 10% of the patients who initially seem like a good fit,” he said. “That’s why you need to get buy-ins from the entire staff.”

Conversely, colleagues should be kept well informed about any developments with their patients. “If you don’t, they won’t refer back to you because doctors are very territorial,” Saltzstein said.

Establishing a thriving research program won’t happen overnight, but success will build on success. “It takes time and experience to start a research program—you will definitely go through some struggles,” Karsh said. “But the more trials you do, and do well, your name gets out and companies will come to you.”