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Outourcing-Pharma focus on: FDA clinical trial initiatives

FDA signals new clinical trials flexibility

By Kirsty Barnes , 20-Jul-2006

The US Food and Drug Administration (FDA) has signalled it will soon allow a new "adaptive" approach to clinical trials in order to streamline drug testing and speed drugs to market.

The changes are designed to help the pharmaceutical industry save millions of dollars in drug development costs - which are currently skyrocketing - by saving time, preventing the number of study failures, and reducing the number of study participants required by over 30 per cent.

Currently patients and doctors involved in drug trials are not permitted to know the results of the trial until it is complete.

However, under new guidelines currently being prepared by the FDA, clinical trial sponsors will have the flexibility to examine early results of a trial half way through and modify the trial design in order to improve the chances of a positive result, or cancel the study if it appears ineffective.

"These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments," said Dr Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs.

However, the current guidelines were put in place to prevent any bias that could affect the outcome of a study and critics in the industry believe the adaptive approach could cause the integrity of trials to be jeopardised.

Acknowledging the concerns, Gottlieb said that adaptive designs could lead to "complicated decisions and uncertainty about the best approach for data analysis."

"It may also be true that making decisions during a trial's course can increase the rate of making an erroneous decision," he said.

The FDA said it plans to address these concerns and will be participating in a two day workshop in November to "discuss all of the many issues around adaptive designs."

It is also planning to empower the data safety monitoring board or a similar expert panel to conduct an interim look at results and make decisions about how best to adapt a trial.

"We also hope to have additional public meetings to help us with the development of these guidances and are open to new scientific advances in clinical trial design that enable us to learn more about how to safely guide clinical decisions," said Gottlieb.

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