The traditional approach to oncology clinical research
Traditionally, clinical trials in cancer have disproportionately been conducted in large academic centers such as the Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, the Dana-Farber Cancer Institute and the Mayo Clinic. These centers are often established as training facilities, according to Jeff Elton, CEO of ConcertAI, with a reimbursement model allowing clinicians to spend equal time on research and patient care.
Elton said the clinical trial participation rate could range from 20% to 60% in such academic centers. But the trial participation rate in community settings is roughly 6%, according to Elton. While the majority of patients are in community settings, only a minority of them have access to clinical trials.”
Clinical trials play a vital role in cancer care as they offer patients access to the latest treatment options, helping them make informed decisions about their care. In addition, new therapeutic entities are often the best options in oncology. “That’s why trials really matter in cancer care,” Elton said.
While community-based groups have shown interest in conducting clinical trials, biopharmaceutical companies have traditionally found academic centers easier to work with owing to their staff and infrastructure.
Biopharma companies traditionally had little incentive to conduct trials in community settings, but that is changing. Many academic centers are running out of capacity. “For biopharma, they’re now finding the academic centers have problems performing in the trials,” Elton said. Some centers have under-accrued patients. Over the past decade, the number of years of patent life after approval has decreased as a result of clinical trial constraints.
Community oncology groups ramp up clinical trial focus
The FDA has recently advocated for increased diversity in clinical trial populations. “Diversity here meant many things,” Elton said. In addition to racial, ethnic and economic diversity, there is also the question of whether clinical trials accurately reflect the background of real-world patients who will receive a cancer drug. That sounds simple, but if you go to the academic centers, patients tend to be younger, healthier and have higher economic means.
One way to improve clinical trial diversity is to shift more studies to community centers, where patients more accurately reflect national demographics. For community settings to close the clinical trial proficiency gap, however, requires building a more robust infrastructure.
A variety of community oncology groups emerging
New organizations such as Exigent Research have thus emerged to improve cancer care. Exigent draws from a network of more than two dozen independent community oncology practices that offer centralized services to accelerate clinical trial access.
Another similar organization is the American Oncology Network (AON). Founded in 2018, AON is a physician-led, community-based oncology management organization focused on optimizing cancer across 18 states.
There’s also OneOncology, a Tennessee-based organization dedicated to providing advanced cancer care in community settings, and the Florida Cancer Specialists & Research Institute, which offers advanced treatment options to patients in almost 100 locations across its community-based network.
Such community oncology groups tend to focus on protecting independent research. “It’s a very interesting way of providing some formalized infrastructure but not forcing a consolidation or merger of different practice entities all over the country,” Elton said. “A lot of these practice entities want to stay independent. They want to stay locally aligned and continue working with local hospitals.”
Community oncology groups’ level of publishing activity and impact on treatment guidelines may trail that of academic medical centers, which have a historically more significant focus on research. But community oncology groups are finding increased engagement with leading biopharmas and are thus receiving more support for clinical trials.
Community-based oncology organizations will likely expand their influence as they broaden their research efforts. Although these groups have traditionally had lower levels of publishing activity and impact on treatment guidelines compared to academic medical centers, they are now receiving more support from biopharmaceutical companies.
Another factor that could bode well for community settings is biopharma’s increased focus on the concept of burden when designing clinical trials. The goal is to “reduce burden for both patients and practices,” Elton said.
Filed Under: clinical trials, Drug Discovery