CT site's unique research model reaps success and contented PIs
PIs receive needed CR support services
Everyone agrees that these are difficult times for physicians who wish to start working in clinical trials. They often have trouble enrolling in new trials, and the budgeting and documentation realities may lead to disillusionment before their first studies are completed.
There is hope, however.
A new clinical research (CR) model takes away principal investigators' (PIs') headaches and gives them the freedom to pursue the type of research they desire, while still making a fair return for their time investment.
This model has been successfully employed by HOPE Research Institute (HOPE) of Phoenix, AZ, which has 25 staff CR employees, 12 physician PI contractors, and four partners, says Patricia Adams, managing partner and co-founder.
"HOPE was started in 2002 with three partners, and we added an investigator as we were growing," Adams says. "There has been a constant growth curve since we started with five clinical trials."
Now the CT site handles 50 clinical trials and anticipates growth to 75 CTs by 2010, Adams says. Also, the organization has been profitable continually since its sixth month of operations, she adds.
The CT site pays investigators a percentage that is above the industry's average for CT work, Adams says. "It's up to HOPE to make sure the trial is running efficiently and that there's a little profit left after all the overhead expenses," Adams says. "The physician doesn't have to slow down in his clinical practice, and it makes it easier for him to see a research patient while also seeing clinical patients."
For all of these reasons, the CR model has been popular among physicians who've worked with HOPE Research Institute, says Jeffrey Gitt, DO, principal investigator and a partner at HOPE Research Institute.
"This is something I'm sure will catch on because people know we're successful, and we're very excited about this," Gitt says.
HOPE Research Institute recently received full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.
"We do classic sponsor-supported clinical research that grassroots America is involved in," Adams says. "We strictly do the research, and our investigators provide clinical care and function as both clinicians and investigators."
HOPE Research Institute provides any CR staffing, documentation, and other support an investigator needs, she notes.
"Our investigators are very excited to work with HOPE because HOPE makes sure they're doing a good job, and we can help them handle audits," Adams adds.
Opportunities in many specialties
The model creates opportunities for researchers to do research in different specialties, Gitt says.
"So we do research in my area of neurology, but also have research in general medicine, podiatry, ophthalmology, and others," Gitt says.
"The other advantage is we have a group of very bright people, each of whom has a different role," Gitt explains. "We have people who do study acquisition, looking for new studies; people who market studies; people who handle regulatory concerns and the IRB."
The clinical research environment has changed a great deal since the 1980's, when Gitt first became a researcher, he says. These days, any doctor who gets involved in research because he or she wants to make money won't be happy, Gitt says.
"The time investment and commitment to doing a study can be larger than they expect, and frustration in getting all the paperwork completed can be far greater than they anticipated," he explains. "You have to like research and getting involved in cutting edge technology, and research has to be somewhat altruistic."
One of the drawbacks for physicians who are interested in research is that they may not have staff with the right skills to engage in clinical research, Gitt notes.
"For an individual doctor to obtain studies, get regulatory approval, do all the paperwork, and get everything done, including recruiting patients and getting it to flow from a financial perspective is almost impossible," he says. "If they don't have the right help and aren't savvy, they'll fail."
So HOPE Research Institute provides these individual physicians with the research expertise they often don't have.
"Having the right people in place allows us to free ourselves up to take care of our patients, rather than worrying about clinical trials details," Gitt says.
The model also provides a possible answer to some goals in the research roadmap promoted by the National Institutes of Health (NIH) of Bethesda, MD.
According to NIH meeting minutes in 2007, Elias A. Zerhouni, MD, NIH director, has a top priority and passion of finding new investigators. He acknowledges the common barriers to engaging new investigators, including lack of time and training.1
"Many mom and pop research organizations don't succeed," Adams says.
So HOPE Research Institute's model is attractive to physicians interested in clinical trials, Adams says. "They ask me how to put together a research organization," she says.
Often these new investigators will attempt to build their own CR site from the ground up, but typically they end up quitting when they become frustrated with the realities of the day-to-day CT work, Adams adds.
"It's easy to assume that people with medical and clinical expertise could easily go into research, but research requires unique skills," she says.
There are a number of reasons why the model has done well, but two stand out:
- Adams envisioned the enterprise as being flexible and moving with CR trends, and it's been successful in doing so.
- Investigators have learned not to choose trials where they anticipate problems with enrollment.
"We do not take trials that we don't believe we can succeed in," Gitt says. "I have had 70-80 trials, and I've had none where we have not enrolled any patients."
Gitt has turned down trials that he doesn't believe are in the patient's best interest or where he doesn't believe in the investigational product or when the CT would be in competition with another CT that HOPE Research Institute has underway.
"Part of our success involves PIs like myself taking on studies where we are honest and believe we have a patient population where we can find people," Gitt explains. "It helps if you've done research before and you have a long track record."
- Department of Health and Human Services, National Institutes of Health, Office of the Director, Office of Portfolio Analysis and Strategic Initiatives, Council of Councils Planning Meeting, Nov. 8, 2007. Meeting minutes. Web site: http://opasi.nih.gov/council/110807minutes.pdf.