Surrogate Endpoints & Continuous Trials
Jul 31, 2018 16:42:56 GMT
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Post by icemandios on Jul 31, 2018 16:42:56 GMT
Gottlieb teases guidance on continuous trials, touts surrogate endpoints
By Lisa LaMotta
Published July 30, 2018
Dive Brief:
The Commissioner cited one statistic published in the Journal of Health Economics that shows the cost of drug development rose 145% between 2003 and 2013.
Dive Insight:
Since joining the FDA last year, Gottlieb has been especially public about changes he wants to make at the drug oversight agency.
Though there is little the FDA can do to force companies to price drugs lower, he has argued that boosting competition and lowering the cost of drug development can help reduce prices as well.
The agency has made a number of moves to speed generic drugs to the market and has created pathways to make it easier for biosimilar drugs to gain approval. Gottlieb has also criticized branded drug manufacturers about the moves they've taken to block the entry of biosimilars and keep their dominance in certain markets.
"It's becoming harder and harder to be second [to market]," he pointed out.
He cited examples of ways the FDA is hoping to streamline the clinical trial process from the traditional three-phase, randomized process — now the gold standard of drug development — to less costly and time-consuming approaches.
One example he cited are the Master Clinical Trial Protocols, which provide for a "hub-and-spoke" design that uses a common control group against a variety of drugs, allowing for fewer patients to be enrolled in trials.
He also cited the use of continuous trials — something used in oncology — which compress the traditional three trials into one long ongoing study.
The agency is also focusing on surrogate endpoints that can serve as a marker to show efficacy when traditional clinical endpoints are harder to establish or may take longer to reach.
In addition, Gottlieb noted that while he has focused mostly on clinical trials for drugs, he is also pushing an initiative to streamline the development process for medical devices. The FDA is teaming up with the Medical Device Innovation Consortium to use computer modeling and simulation to develop "virtual patients."
By Lisa LaMotta
Published July 30, 2018
Dive Brief:
Food and Drug Administration Commissioner Scott Gottlieb took to Twitter this weekend to give a "tweetorial" on how the agency hopes to streamline clinical trials and lower the cost of drug development, touting the use of surrogate endpoints and continuous trials.
"A lot of time and cost is spent between the starting and stopping of the traditional 3 phases. Continuous trials can save time, lower costs and reduce the number of patients. Look for new guidance soon from #FDA on how developers can conduct these 'expansion' trials," he tweeted.
Dive Insight:
Since joining the FDA last year, Gottlieb has been especially public about changes he wants to make at the drug oversight agency.
Though there is little the FDA can do to force companies to price drugs lower, he has argued that boosting competition and lowering the cost of drug development can help reduce prices as well.
The agency has made a number of moves to speed generic drugs to the market and has created pathways to make it easier for biosimilar drugs to gain approval. Gottlieb has also criticized branded drug manufacturers about the moves they've taken to block the entry of biosimilars and keep their dominance in certain markets.
"It's becoming harder and harder to be second [to market]," he pointed out.
He cited examples of ways the FDA is hoping to streamline the clinical trial process from the traditional three-phase, randomized process — now the gold standard of drug development — to less costly and time-consuming approaches.
One example he cited are the Master Clinical Trial Protocols, which provide for a "hub-and-spoke" design that uses a common control group against a variety of drugs, allowing for fewer patients to be enrolled in trials.
He also cited the use of continuous trials — something used in oncology — which compress the traditional three trials into one long ongoing study.
The agency is also focusing on surrogate endpoints that can serve as a marker to show efficacy when traditional clinical endpoints are harder to establish or may take longer to reach.
In addition, Gottlieb noted that while he has focused mostly on clinical trials for drugs, he is also pushing an initiative to streamline the development process for medical devices. The FDA is teaming up with the Medical Device Innovation Consortium to use computer modeling and simulation to develop "virtual patients."
"FDA is also looking to real world data collected from device registries and electronic health records to answer important premarket and post market questions potentially allowing sponsors to meet evidence needs in less time, at lower cost," he added.