Precision PromiseSM, a first-of-its-kind adaptive clinical trial platform developed by the Pancreatic Cancer Action Network (PanCAN), is poised to offer a more intuitive, expeditious, and cost-effective alternative to traditional randomized controlled trials (RCTs) in pancreatic cancer.
The standard oncology clinical trial model can take up to 7 years to test 1 therapy at an expense of $30 to $50 million dollars. By contrast, the patient-centric Precision Promise platform has been designed to evaluate the safety and efficacy of multiple treatments in as few as 3 years and at half the cost. In the United States, the 5-year survival rate for pancreatic cancer approximates 10%; this clinical reality underscores the customary RCT format as unconducive to the lethality of the disease.
Through the establishment of the Precision Promise platform, PanCAN seeks to expand on the 10% success rate seen with RCTs over the past 20 years. Eligible patients will have the opportunity to enroll in Precision Promise at 1 of 15 platform consortium sites across 10 states nationwide. Perlmutter Cancer Center of NYU Langone Health in New York, New York, The University of Texas MD Anderson Cancer Center in Houston, Texas, and Moores Cancer Center at UC San Diego Health in California are among the participating Precision Promise locations.
Precision Promise will reportedly enroll patients with metastatic disease, who will be afforded the opportunity to receive first- and second-line therapies in 1 clinical trial on a case by case basis. In a standard RCT, patients would typically receive 1 investigational treatment while enrolled on the trial.
The adaptive platform, which is expected to expedite the drug development process and accelerate the pathway to FDA approval, will allow investigators to more promptly identify effective and non-effective experimental treatments than the traditional RCT, for which results are often not known until the trial’s completion. Investigators will subsequently be able to focus their efforts on the therapies with the potential to offer the broadest benefit.
“By designing a more patient-centric trial platform, we are able to test promising new therapies more quickly and learn from fewer patients if a treatment is working,” said Diane Simeone, MD, chair of the PanCAN Precision Promise Steering Committee and Precision Promise Principal Investigator at Perlmutter Cancer Center at NYU Langone Health. “The patients that enroll will also receive best-in-class supportive care alongside treatment with biomarker testing to better understand why treatments work in some patients but not in others. This approach should serve as a model for the next generation of trials–not only for pancreatic cancer, but for all diseases.”
PanCAN’s introduction of the dynamic Precision Promise platform emblematizes oncology’s mounting shift towards more adaptive trial designs in disease settings with high unmet need, such as glioblastoma. A full list of the Precision Promise member institutions that are actively enrolling patients can be found on PanCAN’s website.
Adaptive Clinical Trial Design Is More Cost Effective, Patient-Centric and Allows for Faster Learning Than Standard Trials. News release. Pancreatic Cancer Action Network. October 13, 2020. Accessed December 1, 2020.