Opinion

Adaptive Clinical Trials Set to Revolutionize Treatment for Pancreatic Cancer Patients

In 2011, I lost my brother Eddie to pancreatic cancer, and then a few years later, I lost my other brother Artie to the same terrible disease. One lived 14 months after diagnosis, the other just five weeks.

Pancreatic cancer has the lowest survival rate of all the major cancers. In fact, fewer than 5,000 of the 55,000 people diagnosed this year will reach the five-year mark. Often referred to as the toughest form of cancer, this disease delivers only the feeling of hopelessness for patients and their families. Late detection is a common thread that furthers this feeling.

This cancer is terrifying because it’s hard to find and even harder to treat. Nestled deep in the abdomen, it’s difficult to see. When patients notice back pain, weight loss or jaundice, the cancer has usually already progressed, and dense tissue surrounding tumors makes it hard to treat. Most of the time, patients face a grim prognosis with limited options, but that paradigm is about to face its most serious challenger to date.

A new era of clinical trials is here. Finally, we can counter the aggression and complexity of pancreatic cancer. In 2019, a responsive adaptive clinical trial platform called Precision Promise will evaluate novel therapies alongside the traditional standard of care treatments for pancreatic cancer.

Patients will have access to different experimental treatments in a single trial and the flexibility to receive a second treatment if the first isn’t working. Led by the Pancreatic Cancer Action Network in partnership with leading clinicians, researchers, the Food and Drug Administration, and diagnostic and drug developers, this platform will accelerate critical care for patients and provide long-overdue insight into the disease.

This next generation of clinical trials has been a long time coming. While tremendously valuable, traditional clinical trials are inherently time-consuming and costly. Sometimes, patients find the right fit, and sometimes they spend precious time on treatments that simply aren’t working. While experts strongly recommend that people with pancreatic cancer participate in clinical research, only about 4 percent enroll, making forward progress in new and innovative treatments difficult.

Adaptive clinical trials represent a turning point. Precision Promise will enable patients to join forces with the medical community and other patients to advance therapies in a more efficient manner. Instead of long, expensive trials, there will be a more streamlined approach to enrollment and care. This efficiency can be critical for patients who don’t have a lot of time.

It will also minimize the number of participants needed to speed successful treatments to market. Precision Promise has already partnered with Tyme Inc. to include SM-88, a unique metabolic approach to treating stage IV metastatic cancer, and other novel therapies are not far behind. The net result will be a platform built to accelerate the development of the most promising pancreatic cancer therapies — something this community, as well as future members of it, desperately needs.

The rest of the cancer community is paying attention. Progress made using responsive adaptive trials such as Precision Promise can help pave the way for more agile, cost-effective clinical research that could eventually change the regulatory pathway for all cancer treatments.

It’s the triple threat the cancer community as a whole has been looking for: accelerating the approval of promising therapies, increasing opportunities for patients to access experimental treatments, and creating a more cost-effective model. Using this model as its foundation, Precision Promise and other adaptive clinical trials are gearing up to crack the code on certain cancers, and for pancreatic cancer, waging a new wave of hope after decades of seeking significant forward progress.

The word “promise” evokes both a covenant — an important bond — and hope. It’s time we fully embrace the hope that a cure for pancreatic cancer exists and realize our duty to uphold the promise to finding it.

 

Tommy Thompson is the former secretary of Health and Human Services and four-time governor of Wisconsin, and he also serves on the board of directors at Tyme Inc., a clinical-stage biotechnology company developing novel cancer therapeutics.

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