Tips for expanding research programs
Solid staff, education are key
Clinical researchers may be looking to expand their program horizons as some areas of research continue to grow.
“The fastest growing therapeutic area in our community health system research program is cardiovascular research,” says Joan Dorin, RPh, director of the WellStar Research Institute in Atlanta. “With the FDA requiring extensive post-market data, our medical device research involving investigational and approved products is growing as well.” In addition to conventional drug and device research, researchers are also studying tumor tissue and biological specimens to determine the significance of tissue biomarkers that occur in certain disease states and medical events. “Instead of studying an actual drug, they’re studying biochemical reactions that happen during a medical event to determine risk factors and develop novel treatment options,” says Dorin.
“There’s also an increase in investigator initiated research in our program — physicians asking their own clinical questions, and seeking funding for their studies,” Dorin continues. “It’s an area of tremendous opportunity. Our physician investigators have important clinical questions and appropriate patient populations, and can structure protocols to find answers that benefit the advancement of medical science as well as the treatment of their patients”
Tips for research programs
Dorin, and Gary I. Cohen, MD, medical director, Sandra & Malcolm Berman Cancer Institute at Greater Baltimore Medical Center and member of the American Society of Clinical Oncology board of directors, offer tips for research programs looking to expand to new areas:
• Find staff members who will best fit your needs. “It is not optimal to have one staff member trying to negotiate contracts and study budgets, recruit, consent and manage study patients, and maintain regulatory processes and sponsor audits in addition to other job duties”, Dorin says. “Having a qualified staff will mitigate negative outcomes.”
“Having a principal investigator dedicated to the task of maintaining quality is essentially important,” Cohen says. “That means understanding the studies, taking a few courses to learn to be an investigator, avoiding conflicts of interest, and understanding randomization and investigational agents handled by the pharmacy. Being a principal investigator doesn’t just mean ‘I’ll raise my hand and do it’ — they have to take it seriously and put in the time commitment in the first year to gain the knowledge base and qualifications to run it properly.”
• When possible, have a centralized research office and always use a qualified IRB. “Having a centralized department has really helped to streamline the process,” Dorin says. “We have a variety of clinical trials in many therapeutic areas. We have staff members who are dedicated to specific types of research based on their expertise.”
While WellStar Research Institute has been conducting studies for about 25 years, the research office was centralized in the last 10 years in the wake of federal audits. “Conducting research on human subjects is a serious business with serious repercussions and requires strict adherence to the federal regulations,” Dorin says. “We were fortunate — we did not receive warning letters or sanctions, and we learned to incorporate processes to mitigate negative audit outcomes into the building of our infrastructure,” Dorin adds.
• Develop the study budget and how the site will get paid. “The study budget is important to cover our costs, but it is imperative to the success of our program that we cover the expenses involved in our program,” Dorin says.
“We do research for its own values and benefits,” Cohen adds. “If you just break even doing research, that might be very satisfying. Profit to me means just making the program work so you’re breaking even. If you make a profit, you can spread it out and expand the program or whatever you like.”
Cohen suggests beginning with just a few studies that you know you can fill. “Focus on a study that you know you can accrue 6-8 patients in one year,” he says. “If you do two or three studies like that and put on 20-25 patients per year, it’s a good number to shoot for. You know you can get enough reimbursement for trials to cover the costs. If you have fewer patients accrued, you won’t get your investment back.”
• Staff communication and education are key. “Communication is always a challenge, between physician, research staff, patients, the IRB — everyone,” Cohen says. “It’s a lot harder to have all these things in a study than to have them on their own.”
It can be a particular challenge for hospital nurses, pharmacy staff, and other staff who have never cared for clinical trial patients and are unsure of how to proceed.
“When you’re first starting a program in a hospital system, it’s a little scary for care providers. There may be resistance because they’re afraid they’ll do something wrong, or the patient might not get treated,” Dorin says. “There can be misconceptions with clinical trial drugs. It takes constant education to make sure that everyone understands that the investigational product has already been proven to be effective and safe and no one is getting a placebo without also receiving treatment.”
“In the pharmacy, if there’s an investigational product involving blinding, pharmacists have to step out of their routine,” Dorin continues. Sometimes the blinding process is complicated and dispensing requires extensive record-keeping. Nurses on the floors also have to follow extra administration guidelines, and lab personnel may be asked to follow protocol procedures that are different than the usual routines.
• Recruiting study patients. WellStar’s electronic health records enable its researchers to recruit patients from the health system, rather than relying on physicians to contact researchers with candidates. “Again, having a centralized research office allows us to control and enhance recruitment strategies across the system, while assuring adherence to all regulatory guidelines,” Dorin says. “We find the patient first, then we consult with the investigator to discuss eligibility.” This approach simplifies the recruitment and consenting process across the system by ensuring the physicians do not have constantly look for qualified patients. “It takes constant communication between physician investigators and the research team, but allows us to reach optimal recruitment goals by taking the burden of patient screening off of the physician”
Recruitment can be a challenge for other programs, particularly with oncology. “What’s the likelihood that you’re going to see someone with a particular cancer with a certain gene transformation? It’s very small,” Cohen says. “These are the ones that probably belong in the major cancer centers.”
For other studies, “if you have something really innovative, you could send a letter to your colleagues in the area and you could get some patients from that,” Cohen says. “Mostly what you need to do is look at what patients you are seeing in your general practice and what can you do about that.”