Future Medicines and Devices Emerge from Local Clinical Trials

Clinical trials produce new drugs that can slow the progress of cancer, boost the immune system and much more.

But they also include less-significant but equally important advances that improve a cancer patient’s quality of life.

Research into both and much more is taking place at The Lakeland Regional Health Hollis Cancer Center in Lakeland.

Last August, Lakeland Regional Health’s oncology program was awarded its first gold Accreditation with Commendation, the highest level of recognition, from the American College of Surgeons’ Commission on Cancer. It enrolled about 100 people in trials last year, and 150 are being followed from previous studies.

Six Things You Should Know About LRH’s Clinical Trials

It’s hard to get people involved.

Getting people involved in clinical trials is not always easy. Dr. Madhavi Venigalla, LRH’s Hematologic Oncologist/Medical Oncologist who also serves as the principal investigator for cancer clinical trials, said national statistics had not been strong for patient enrollment — less than 3 percent. But the number increased as Federal Drug Administration physicians and clinical trial boards regulated studies and reduced fear. They now try to bring better drugs to the market faster so patients have access to better medicines or more options for care.

“Still, there have been thousands of patients over the last 30 to 50 years who have contributed to drug development,” Venigalla said. Doctors, nurses and other care team members provide facts and information to potential trial candidates, arming them with knowledge and dispelling fears. In the end, though, it’s up to the patient to decide.

Venigalla says doctors might suggest patients enroll in clinical trials if they’ve exhausted all other care. “Some patients have used all the medicine. We bring the appropriate clinical trials to patients. We have an interest and strong ethical sense to contribute to clinical trials. The more drugs that come to the forefront, the better for patients.”

LRH’s multidisciplinary Tumor Board discusses new cancer patients or developments in current cancer patients to get everyone involved in their care to think about whether there is a trial to fit that person, said Rebecca Delph, LRH’s Research Nurse/Team Leader.

Venigalla added that if nothing is found locally, they often will look nationally for trials. Some large universities or medical centers will seek candidates from other states to get more data in a short time, allowing them to analyze information quickly. It also gives them a more well-rounded group of participants. Some trials are international..

Patients participate for a variety of reasons, but always for good.

Humanity, Venigalla said. “All of us have this innate ability to want the very best for ourselves, but also for the greater good, for society at large. If each patient thought they may not benefit, so why bother, we wouldn’t be where we are now.”

Past studies have led to major improvements in treating lung cancer, melanoma and the like, improving survival rates compared to 30 years ago.

“It’s a sense of doing good to others,” she said. “New drugs come to market and improve thousands of lives. They should be commended for that. Patients move the target. Thousands of researchers come up with these ideas — how to find drugs that are more targeted, how to target symptoms. The doctors bring new molecules. But patients participate and contribute outcomes.”

Venigalla said she thinks if doctors can get patients to participate in trials through education and community engagement, it will “improve the cancer prognosis for many.”

LRH works with other clinics and universities.

Lakeland Regional Health has had a membership in the Mayo Clinic Care Network for the past two years, allowing Mayo physicians to perform comprehensive evaluations for patients in Lakeland through eConsults. It’s a second opinion without the patient having to travel, Venigalla said.

“They will look at radiological studies, pathology, the medical oncologist recommendation, all sent through a portal to a Mayo Clinic doctor who specializes in that type cancer. In two days they will weigh in,” she said. The consultation is then shared with the patient.

So far, the partnership has been working well, and LRH patients are “very satisfied,” Venigalla said. Mayo also provides medical education and phone call consultations, all of which benefit patients here. “They are getting peace of mind knowing they are getting Mayo Clinic-level care here at home.”

There’s more good news coming.

LRH will be one of 15 sites in Florida working with the Moffitt Cancer Center in Tampa to study health disparities in pancreatic cancer, said Saira Bahl, LRH’s operations manager for Research and Clinical Trials. “Florida has such a diverse community, and with a high number of lives lost to pancreatic cancer we need to look at ways to personalize care for individuals affected by pancreatic cancer.”

Different types of trials help a variety of patients.

Trials can also be related to quality of life. Delph pointed to one in which patients had to return to the center 24 hours after receiving chemotherapy to get a shot to help their white blood cells. “Now they get a little injector on their arm so they don’t have to come back to the center the next day. It sounds simple. But when you’ve had chemo and you’re not feeling well and you have to get dressed and come down for an injection — it’s a better quality of life.”

Many trials last about three years, at which point data is analyzed and the results are published. But the length of a trial can vary widely.

LRH oversaw symptoms in a head and neck clinical trial that lasted while patients were receiving cancer treatment. “They were evaluated, it was very finite — only during the two to three months they received chemo and radiation,” Delph said. “We followed the patients for six months to two years to see if the drug did what it was intended to do.”

But it’s not unusual for some treatment trials to go 10 to 15 years, or even 20, she said. The long ones include following the patient to see how they are doing, whether the cancer has returned, what a patient’s quality of life is, etc.

Bahl says LRH receives inquiries about trials from sponsors. “We seek out trials based on what the latest research shows, and physicians will come and see if a trial is available and if it fits our population. We screen three to five trials per month on average.”

Success stories help future patients.

After Gardasil was developed to fight off cervical and other cancers by keeping the human papilloma virus at bay, Lakeland Regional continued to screen for cervical cancers. Its efforts have been recognized by the American Cancer Society through an HPV Partnership Award that allows community physicians a better understanding of how to best educate patients about the importance of the HPV vaccine. “There was research, a drive to market, and now we have a campaign that has the potential to significantly help reduce HPV-related cancers in the community,” Bahl said.

Delph said the same is happening with immunotherapy drugs, where several trials helped develop new molecules and brought new drugs to market. “It’s a completely different way of treating cancer — making people’s own immune system fight the cancer.”

Venigalla said a multi-pronged approach works: Prevention and education, accelerated drug development, participation in clinical trials, and more targeted and personalized cancer care. “All are important. We are heavily involved in prevention; physicians go into the community.” Lung cancer is the No. 1 killer, she said, so physicians urge former smokers to be screened for low-dose CT scan screening. “That will pick up a tumor much sooner or prevent it from becoming cancer.”

All trials have led to new treatments and “speak well of the cancer center’s commitment to patients,” Venigalla said.

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