Pancreatic cancer is a top cause of cancer death in the United States, where the incidence and death rates are on the rise. Each year, more than 60,000 Americans are diagnosed with pancreatic cancer and the five-year survival rate is as low as 10 percent.1 Unfortunately, there is a shortage of effective treatments for Pancreatic cancer. Identifying effective treatments has posed to be a challenge, as the failure rate in Phase 3 PDAC clinical trials is over 95%.2,3 Since these clinical trial results have been disappointing, many pharmaceutical sponsors have been rethinking their investment in the therapeutic area, which is a potentially devastating situation for patients.
Situation:
In response to the negative clinical trials results, Pancreatic Cancer Action Network® (PanCan®)4 has launched Precision PromiseSM,5 which is a Platform Trial (Master Protocol) aimed at identifying effective and ineffective treatments quicker than traditional clinical trials. This is a perpetual trial that evaluates multiple treatments in various subtypes of Pancreatic cancer.
The goal of this Complex Innovative Design is to improve patient outcomes at an accelerated pace while de-risking entry into the space for pharmaceutical sponsors. PanCan takes on the role of the Sponsor within Precision Promise and allows investigational treatments to be included from various pharmaceutical companies.
Challenge:
Since this Platform Adaptive Trial is perpetual, it takes a lot of planning, and collaboration to be successful. In addition, Precision Promise has characteristics that make it rather complex:
- It is a Platform Trial
- Rather than studying a single treatment in a single patient population, this trial evaluates multiple treatments in multiple patient populations called subtypes.
- It uses a Bayesian Response-Adaptive (BRAR) algorithm for Randomization.
- BRAR treatment assignment probabilities are updated continuously based on accumulating patient response data requiring data integrations between the Berry Consultants and the IRT.
- The Master Protocol required the IRT to consider various scenarios for treatment eligibility.
- Many treatments in the trial were combination therapies, therefore, the IRT and Randomization algorithm was required to prevent assignment to any previous treatment.
- New treatments opened are staggered across sites.
- The Randomization algorithm and IRT was required to account for preventing randomization to any Treatments at sites without IRB approval.
Almac Clinical Technologies Solution: Partnership, Collaboration, and Seamless Operations.
This Case Study outlines the complexities involved with implementing this Complex Innovative Design, and how through effective collaboration, the IRT was set up for success, featuring insights from an interview with Regina Deck, Vice President, Clinical Trial Operations at PanCan.
Click here to discover how PanCan have utilised Almac’s IRT expertise to accelerate the outcomes of their adaptive platform & improve patient care.
References
- American Cancer Society, Cancer Facts and Figures 2014-2020.
- Wong CH, Siah KW, Lo AW. Estimation of clinical trial success rates and related parameters. Biostatistics (2018):1-14. https://doi.org/10.1093/biostatistics/kxx069
- Biotechnology Innovation Organization, BIomedtracker, Amplion. Clinical development success rates, 2006-2015. Published. 2016
- PanCan: https://www.pancan.org
- Precision Promise: https://www.pancan.org/research/precision-promise/