Oncology clinics are partnering with technology companies to determine what tests to best offer.
In addition to focusing on medical dermatology testing, a northwest Arkansas lab is preparing to expand to include cosmetic dermatology testing.
Children's hospitals in the area are actively recruiting participants to expand their reach and offer clinical trials locally.
Several clinics and health systems in Northwest Arkansas and elsewhere in the state offer treatment through clinical trials. They agree that expanding access to more patients is a worthy goal. They caution that the process of being accepted into a clinical trial can be rigorous.
“Game changer”
Highlands Oncology and technology company Paradigm have partnered to assess the feasibility of new clinical trials and screen patients for enrollment, according to a joint press release. Paradigm will use patient clinical data from Highlands to streamline all aspects of clinical trial enrollment, the release stated.
Paradigm is a game changer, says Tracy Hampton, director of marketing and administrative services at Hyland. Paradigm uses algorithms and technology to scan electronic medical records to identify patients who qualify and could benefit from one of the available clinical trials, she says. All of Hyland's work is done with the patient's consent, and patients can opt out of participating in a trial, she says.
“Over the past two years, Highlands has increased patient enrollment in clinical trials by 45 percent, reducing the burden on our research department,” said Adam Torres, director of research and development at Highlands Oncology.
The partnership also allows Highlands to access new clinical trial opportunities from pharmaceutical and biotech sponsors through Paradigm, according to a press release. The technology company offers trials to sponsors through algorithmic technology that pre-screens Highlands' local patient demographic, capabilities, research portfolio, interests and objectives. Sponsors include pharmaceutical companies such as Pfizer and AstraZeneca, Torres said.
All of Hylands' ongoing clinical trials are listed on its website, which says clinicaltrials.gov lists all clinical trials around the world.
Hampton said the clinical trial allows patients to have access to cutting-edge treatments that aren't widely available, and that Highlands Hospital is a leading provider of clinical trials in Northwest Arkansas.
Hampton said each clinical trial has different regulatory guidelines that clinics must follow when identifying eligible participants, such as the stage of cancer, previous medications, etc. He said a government-regulated list of criteria helps keep clinical trials pure and doesn't skew the results.
Hampton said finding trial participants can be difficult, even if patients are willing to take part, because it can be hard to find patients who fit the criteria for a particular study.
Using Paradigm's platform has expanded trial access to broader groups and increased trial enrollment without adding to the research team, Hampton said. The technology-based platform also allows staff who previously spent time reviewing records to identify eligible participants to spend more time working with trial eligibility and membership, she said.
Paradigm is a third-party resource, said Torres, who added that doctors at Highlands use the platform like a website, logging into Paradigm to see patients' symptoms and what clinical trials are available to them.
Torres said oncology research is rather complex as it involves many different aspects such as mutation status and available treatments.
Highlands has research-minded physicians who explore clinical trial options for patients, Torres said. The research department's goal is to offer clinical trials to every patient who comes in, so patients don't have to travel across the country to participate in investigational treatments, he said.
The trial is voluntary, Torres said. Doctors can offer it to their patients, or patients can ask their doctors to let them participate in the trial. The research department will further explain the trial to patients and give them time to consider it.
Implemented in stages
Clinical drug trials are conducted in stages before a drug goes to market, Torres said, with each trial typically divided into three phases:
The first phase of a clinical trial is when patients are given the drug for the first time. During this phase, they are closely monitored. The first phase looks at how well the drug works, how it interacts with diseases, whether it's safe for patients, and what the side effects of the drug are, he said.
He said competition will be fierce as the first phase will see between three and nine patients being tested on the drug for the first time.
Torres said more participants will be added in the second phase, depending on the type and rarity of the disease being treated, which could include up to 200 participants to study the drug's efficacy and side effects.
The third phase of the trial will expand the number of patients from hundreds to thousands, Torres said. This will allow researchers to see if the drug works as expected, he said. Drugs are typically submitted to the FDA for approval after the third phase.
“A vast rural state”
Michael J. Biller, director of the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences, said that while applications for his institute's cancer clinical trials are open to all patients, the trials have very strict inclusion and exclusion criteria. He said doctors use these criteria to decide who to talk to about treatment. Clinical trials are an option for everyone and part of the standard of care, he said.
“Arkansas is a big rural state,” said Biller, who has worked in more populous areas such as Boston and Birmingham, Alabama. He said UAMS patients travel to get care. The institute is working to connect and partner with health systems in other parts of the state so they can provide care. He said UAMS has partnered with Highlands Oncology, which allows UAMS physicians to offer Highlands' clinical trial portfolio to UAMS patients.
Villar said UAMS is looking to expand cancer care to more rural areas of the state, such as Helena, Lake Village and other cities on the eastern border. He said they are seriously considering procuring a fleet of minivans to transport patients to UAMS just for cancer clinical trials, so that cancer patients who couldn't get into trials because of the short distance can still get in. He said through this transportation plan, they will accommodate patients, including staying overnight at the hospital if necessary.
Not just cancer treatment
Laura James, director of the Translational Research Institute at UAMS, said that over the past decade there has been more emphasis on understanding how social determinants affect clinical trials.
Social determinants of health could include distance to a family doctor or availability of healthy foods, James said.
He said the Translational Research Institute is conducting more than 200 clinical trials for diseases such as Parkinson's, Alzheimer's and diabetes. The institute also conducts clinical trials for the treatment of pain and joint disorders.
Rebecca Baltz, principal investigator at the Northwest Arkansas Clinical Trials Institute, said most of the clinical trials being conducted at her institute are in Phase 3. She said most of the clinical trials at the clinic are focused on medical dermatology, but there are some trials planned to start that focus on cosmetic dermatology.
Clinical coordinators are discussing the trial with anyone who is interested, she said.
“Each trial has strict criteria that we follow and talk to those who are interested to determine whether they are eligible,” Baltz said, adding that acceptance usually requires testing by herself or other researchers at the clinic.
Baltz said the institute doesn't just work with pharmaceutical companies on clinical trials.
“It's more about what suits our area and our site,” she said.
Baltz said one of the current areas of focus in dermatology is hidradenitis suppurativa (HS), which the Mayo Clinic describes as a condition that causes small, painful lumps to form under the skin.
Baltz said the disease has been difficult to study because there was no good treatment for it before, but there are now better treatments for the disease and the institute is testing several new treatments for HS.
Baltz said working as a principal investigator has given him a greater understanding of how much scrutiny any drug must undergo before the FDA will approve it for use.
“Clinical trials are an important part of medicine to determine what really works and is safe for the people I care for as a physician,” she said.
Focus on the child
Arkansas Children's Research Institute has been working with families through clinical trials for decades, said Pete Mourani, the institute's director.
He said the pediatric research team has conducted trials on diseases including childhood cancer, blood disorders, food allergies and Duchenne muscular dystrophy.
Currently, the institute is conducting more than 280 clinical trials, Mulani said, and the hospital is expanding its research footprint and opportunities to initiate clinical trials at Arkansas Children's Northwest.
“By volunteering in clinical trials, patients and their families have an incredible opportunity to shape care for future generations,” he said.
He said families can learn more about the hospital's clinical trial services on the hospital's research page at archildrens.org/research.
