Outgoing FDA Commissioner Scott Gottlieb, M.D., has criticized the “continued reluctance” of sponsors and CROs to adopt innovative approaches to clinical trials. Gottlieb challenged industry and academia to invest in new approaches and realign incentives to make clinical research more agile and effective.
During his tenure at the FDA, Gottlieb has overseen efforts to change how clinical trials are run and regulated, culminating in the publication of a clutch of guidance documents this week. Gottlieb sees the FDA’s efforts helping sponsors cut the time and resources it takes to generate safety and efficacy data, for example by facilitating the use of master protocols, mobile technologies and new endpoints.
In Gottlieb’s view, the FDA has created opportunities to streamline clinical development and cut time to market that sponsors are failing to take, in part due to legacy business models that discourage collaboration and data sharing in the “extraordinarily complex and expensive” clinical trial sector.
“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations. In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable,” Gottlieb said in a statement.
Gottlieb went on to say that the FDA appreciates that the scientific and technical complexity of moving to new models represents “a real and ongoing challenge.” But he also challenged industry and academia to invest in and use novel approaches. Gottlieb singled out the development of new incentives “that reward collaboration and data sharing across the clinical research enterprise” as one way to move the field forward.
In making his case that the clinical research sector is delaying and stymieing the advance of new ways of assessing drugs, Gottlieb linked out to an Outsourcing-Pharma article that quoted Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on how the field needs to change.
“We must bridge clinical research and healthcare or the entire enterprise is going to fall down. There is just no choice,” Woodcock said.
Some clinical trial professionals have long seen the technology-enabled integration of clinical trials into routine healthcare as the holy grail of drug development. Mobile technologies and other tools can facilitate a move in that direction but, as Gottlieb discussed in his comments, structural barriers to such a radically different approach to clinical trials remain.
The guidance documents published this week on clinical trial enrichment strategies and risk-based monitoring lay the groundwork for improved subject selection and a more targeted approach to one of the most costly parts of human studies. But they won’t independently usher in the new approach to clinical trials Gottlieb outlined in perhaps his parting shot on the topic as FDA commissioner.