By designing a QbD model the US Food and Drug Administration (FDA) hopes to cut clinical trial monitoring requirements. For now the FDA and collaborators in academia and industry are just considering what QbD in clinical trials would entail but the agency is confident it will find a model.
“I think [QbD in clinical trials] will come to pass in the next 25 years”, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA, said in an AAPS 2011 keynote on the next quarter of a century at the agency.
In QbD, a term the FDA uses for manufacturing, the need for oversight is reduced by having a process that produces a quality product each time. Manufacturers achieve this by understanding process parameters and clinical trial sites would need similar knowledge of their operations.
Moving to QbD for studies in humans is part of a push by the FDA “develop more robust [clinical trial] infrastructure”, Woodcock said. It also fits with Woodcock’s vision of how the role of regulators will change in the coming 25 years.
Woodcock said: “I believe that if we’re successful drug regulation will become less intrusive and less complex. That ought to be our goal.” Current complexity and intrusiveness is driven by a lack of certainty, Woodcock said. A QbD model for clinical trials could cut uncertainty.
Animal testing alternatives
Woodcock expects pressure on industry and regulators to adopt alternatives to toxicology tests in animals to ramp up in coming years. Advocates of alternatives claim in-vitro and in-silico testing can replace animals in generation of preclincal toxicology data.
However, Woodcock said there are still lots of questions to answer before regulators and industry move away from animal testing. Woodcock expects a “tumultuous” period as conflicting views on the need for animal testing are debated.