Cancer clinical trials forum explores recruitment opportunities

Forum participants discuss challenges and solutions for getting more participation from Florida patients

CANCER PATIENTS who participate in clinical trials get access to state-of-the-art and therapeutic technologies. But attracting cancer patients to participate is often a difficult task. In September, the American Cancer Society sponsored a Tampa Clinical Trials Forum to explore ways to increase recruitment among cancer patients.

“In Florida every year, about 110,000 people are diagnosed with cancer,” says Dr. Christopher R. Cogle, professor of medicine at the University of Florida, who participated in the forum. “Approximately only 3,000 join an interventional clinical trial where they are given new drugs or new diagnostic technology.”

“What we discussed was the reason for the low rates, especially in minority populations where there is a distrust of the medical system,” Dr. Cogle says. “People with cancer who participate in the clinical trials get access to state-of-the-art and therapeutic technologies. They get critical care, better care, and learn what is and is not beneficial. Only three percent [of the patients] join a clinical trial in the state of Florida. Many patients are missing out on cutting-edge technology and therapeutics.”

“There are four major cancer centers in Florida and one agency that are doing trials and cancer treatments, have interesting developments, and discussed how to increase trials and where they see this going,” says Dr. Sikander Ailawadhi, a forum participant who practices in internal medicine in the Hematology Department at the Mayo Clinic, Jacksonville.

Participating centers included Mayo Clinic with Dr. Ailawadhi; Moffit Cancer Center, Tampa; Shands Cancer Hospital in Gainesville; Sylvester Cancer Center, Miami; and a community practice oncology in Tampa. The five representatives sat and answered common questions and discussed trials “we are now participating in, seeing strategic clinics, getting more diverse populations, and see how this is going forward,” Dr. Ailawadhi observes.

In general, it can be cultural and psychological barriers that prevent a patient from participating in clinical trials. Fear of being a guinea pig is another reason for not joining a clinical trial. Every single drug the FDA has approved is done so because approved clinical trials have been held. Every single drug needs that approval before it can be placed in the marketplace. That is a main reason clinical trials are so very important.

“The numbers (of drugs) are going up that are now available to patients, and that is why patients are living longer— from the benefit of drugs,” Dr. Ailawadhi points out. “Whenever possible, the patient should participate in clinical trials. Large cancer centers like Mayo Clinic have huge trials to move forward and, from our standpoint, get the patient the most treatment and access to newer drugs that will benefit them in the long run.”

“Clinical consortiums are formed to fund the research and pay for the clinical research infrastructure, case report forms, regulations and monitoring board [. . .],” says Dr. Cogle. “Then all the practices have to do is focus on the patient treatment, the practices, and enter the data on the secure case report forms data.” The University of Florida and the University of Miami formed a consortium called OneFlorida Consortium for this purpose. There are others around the state that provide the same function.

“This OneFlorida infrastructure is an investment for the University of Florida through a grant. Not only will it disseminate technology quickly, but it will also get these answers quickly if a certain strategy will work or not,” Dr. Cogle says. “This is good, not just for the patient and Florida, but it is also good for cancer research. If these people show up to a clinic or hospital, then they will be eligible to participate in these clinics.”

Those participating in the forum took home some fresh ideas. “We learned the importance and need for expanding clinics, as well as explaining clinics to the population— especially minorities and people living in rural settings,” Dr. Cogle points out. “We also need to increase support from the Florida legislature, specifically for the Florida biomedical research program, a conduit in which the state grants money to researchers in conditions that impact the health of Floridians.”

Solutions to advance the clinical participation included the need for language on consent forms to be other than English. Short forms exist that can be read in the patient’s native language and when signed, can permit a translator to explain the longer document, Dr. Ailawadhi conveys.

Another suggestion was the need for more centers for clinical trials created across the country to make them more accessible to rural areas and minority neighborhoods. “The main thing is to spread awareness to patients and physicians that clinical trials are always a superior option,” Dr. Ailawadhi concludes, “and should always be considered as much as possible to get the cure for cancer to move forward.”



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