INCREASING THE SUCCESS

INCREASING THE SUCCESS RATE OF CLINICAL TRIALS
Could Adaptive Clinical Trials be the answer?

The price of success is high due to all the money spent on drugs that are unsuccessful. Only 10 percent of drugs that enter clinical trials are approved by the FDA. On average the amount required for a new drug approval process is roughly $2.6 billion.

“As an industry, we need to increase the amount we spend on drugs that reach the market and decrease the amount we spend on those that don’t.” said Rob Lenz, senior vice president, Global Development at Amgen.

Newer methodologies, like adaptive clinical trials, are far more flexible. “With adaptive designs, you can monitor the incoming data and modify the protocol based on what you’re learning as the study unfolds,” Lenz noted. The potential changes need to be spelled out before the trial begins. If the pre-established criteria are met, you can make a range of adaptations.

REDUCE COST AND INCREASE SPEED

In traditional clinical development programs, tradeoffs are necessary if you want to prioritize speed, or cost, or likelihood of success. To optimize for success, you often accrue more data at each stage of the program. However, that makes the program go slower.

Simulating clinical trials can’t make a drug work if it isn’t going to work, but it can help you design an optimized trial with the highest likelihood of providing meaningful and actionable answers.” Lenz said.

For more information on this topic visit The Amgen website.

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