Food and Drug Administration

Streamlining drug approvals can spur innovation and lower treatment costs
By Tommy Thompson

The FDA just issued draft guidance that would expedite the development of groundbreaking cures by empowering drug makers to utilize “adaptive trial designs.”

These designs significantly speed up the traditional drug research and testing process, making it “more efficient and less costly.”

America’s most vulnerable populations should welcome the news. Adaptive trial designs can increase access to drugs that treat cancer, Alzheimer’s, and other chronic diseases.

To prove their drugs are safe and effective, drug makers undergo lengthy FDA clinical trials. In the first phase, only a few patients receive the experimental treatment to make sure it’s safe for human consumption. In the second phase, several hundred sick patients receive the medicine to determine its effectiveness and any adverse effects. During the final phase, thousands are given the drug to detect any unnoted medical complications.

It can take more than a decade for researchers to obtain approval. American patients can’t wait that long.

That’s where adaptive clinical trials come in. These trials allow researchers to alter their testing mid-course based on data they’ve already collected. If they hit a dead end, scientists won’t waste their time or money.

The “Precision Promise” responsive adaptive trial sponsored by the Pancreatic Cancer Action Network is a great example. Participating pancreatic cancer patients will receive multiple drugs simultaneously.

Many of these participants will be given an investigational cancer therapeutic drug known as SM-88. The drug is designed to destroy cancer cells’ metabolism to inhibit any growth. This all happens without sacrificing quality of life.

Other therapies expected in this Precision Promise trial include investigational therapies for patients with specific genetic mutations and investigational agents designed to improve drug delivery to the tumor.

Patients will have access to higher-performing investigational therapies as the trial progresses.

The adaptive nature of this design could completely transform treatment of pancreatic cancer, which has a 95 percent fatality rate. Roughly 44,000 Americans will die of pancreatic cancer this year.

I’ve witnessed the impact of this deadly disease firsthand. My brothers, Eddie and Artie, and my business partner, Ervin, all died from pancreatic cancer. In Eddie’s final moments I assured him I would work with researchers to find a cure. These adaptive trials present the best chance for me to make good on that promise.

Expediting drug launches would also reduce the overall burden of incurable chronic diseases. Consider Alzheimer’s, which affects 5.7 million Americans. Producing a treatment that delayed the disease by five years could save $218 billion annually over the next thirty years.

A faster drug approval process is a lifeline to Americans battling fatal illnesses — it’s encouraging to see the FDA recognize this.

Tommy Thompson is a former Secretary of Health and Human Services (HHS) and Governor of Wisconsin. He is also a board member of Tyme Technologies, which is a clinical-stage biotechnology company developing novel cancer therapeutics intended to be safe and effective across a broad range of tumor types.

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