Why Phase 1 Clinical Trials Are Important for Cancer Patients
Not only has Avera expanded rural access to cancer clinical trials; they have also expanded access to earlier trials, including Phase 1 trials, which offer the most novel treatment options available.
“Many community cancer centers like Avera offer Phase 3 clinical trials. But for a community cancer center like Avera Cancer Institute to offer Phase 1, first-in-human clinical trials – this is extremely rare,” Starks said.
Drugs in Phase 1 are moving from the lab to be given to humans for the first time, in order to prove safety and to find the dose to move forward in the trial. In Phase 2 trials, the drugs are being tested to see if the drug is effective against the cancer. Typically, Phase 1 trials are offered at large teaching institutions due to their complexity and need for expert staff.
Yet Avera has developed that deep bench of expertise. “Our responsibility to the study is to make sure we’re conducting the study as cleanly and as precisely as possible,” Starks said.
Around 15 years ago, Avera began offering Phase 3 clinical trials, which test a new drug in a large group against standard of care, to see if it’s better at treating the cancer or has fewer side effects. “We did very well in enrolling patients in Phase 3 trials, giving patients access to treatments they otherwise wouldn’t have had,” McKean said.
“That participation led to an explosion in developing the skill set to get earlier and earlier drugs and studies in Phase 1 and 2,” Starks said. “We started approaching this very strategically, putting together a road map of the things we needed to do and the personnel we needed to have in place.”
Highly Skilled Research Team
For Phase 1 work, physicians, nurses, advanced practice providers, pharmacists and laboratory staff need to be highly trained for high-acuity care. “We’re dealing with serious disease processes and treatments that can cause significant side effects,” McKean said. “So we need to be very careful to identify symptoms or side effects early on, and intervene as needed to keep them safe.”
“Now, what’s fulfilling and exciting is that we are even seeing patients referred to Avera from academic programs or large cancer centers,” Starks said.
For example, McKean enrolled the first U.S. patient and is the highest enroller in the world in a Phase 1 clinical trial, and she converses regularly about clinical trial progress and results with top cancer experts across the nation and world.
“Avera has proven to be competitive with larger academic cancer centers that have been doing this work for decades. Avera has also been nimble, often being able to open a study to participants in less time,” McKean said. “This is happening at Avera because we care enough about our patients to offer them these opportunities to have more options for effective treatment.”
How Advanced Treatments Help With Late-Stage Cancer
Oncology has more approved drugs than any other medical specialty. “That gives us motivation to keep up and be at the top of our game, and at the same time continue to push cancer care forward,” McKean said.
Thanks to the advancements in cancer care, people with late stage cancer can live longer with better quality of life. “Our goal as cancer specialists is first to cure if possible through treatments like surgery, chemotherapy, radiation therapy, cellular therapy and immunotherapy,” Starks said. “If a patient has progressed to later stages, our goal becomes how to maintain and extend their time as being cancer free or in remission. Thanks to new drugs that are coming out all the time, we’re knocking on that door.”
Learn more about Avera’s commitment to rural health, including cancer care.
