Drug developers spend millions of dollars planning a trial, often times with CRO partners, developing an elaborate infrastructure to run it, finding and enlisting investigators, conducting the trials, and managing the data.
But, as Woodcock noted, “Each time a new drug is tested, the process is repeated, at great expense, only to dismantle the infrastructure when the study is completed. We believe that there are ways to greatly improve clinical trial efficiency, such as widespread use of clinical trial networks and master protocols, and we would like to work with you to examine those possibilities.”
The FDA may look to take a page out of the book of the UK’s NIHR (National Institute for Health Research) clinical research network, which recently restructured, and helps to support thousands of trials per year.
In addition to the master protocol idea for trials, Woodcock called to enhance the science of identifying and evaluating the utility of biomarkers, which can predict and evaluate the effects of proposed drugs before clinical testing and in people.
“However, biomarkers based on new scientific understanding have been slow to come into clinical use, largely because the evidence supporting their validity has been lacking. The lack of new, well-understood biomarkers also impacts drug development, these new tests could speed evaluation of drug performance, including drug safety, and prediction of effectiveness. Similar to the problems with clinical trials, the scientific infrastructure for evaluating the validity of new biomarkers has not kept pace with the need for this activity,” Woodcock added.
She also clarified that the FDA recognizes that there is still confusion about how new biomarkers can be qualified as some sponsors believe that many biomarkers are “stalled” in the qualification process.
“The actual case is that most of the programs in the biomarker qualification process are still in the evidence-gathering stage—which may take considerable time due to the need for more development work within the scientific community,” Woodcock said.
As the FDA approves therapies faster than any other developed country and more quickly than ever before, the agency will look to harness big data to track the safety of new drugs.
“I have aggressively developed FDA’s Sentinel Initiative, a national electronic system that is transforming FDA’s ability to track the safety of drugs and biologics once they reach the market. Sentinel enables FDA to actively query diverse health care data sources—such as electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely,” Woodcock said.
But she also noted that “the science of using evidence from clinical experience to establish product effectiveness…is still in its infancy. So we must first develop the methodologies needed to harness its promise.”