The FDA is teaming up with drug developers, academics and others on a new program that urges regulators to agree on disease-specific biomarkers that can be used in the clinical trial process. And their goal is to find out earlier if they're on the right track or need to move on--cutting costs and shortening development cycles.
Initially the focus will be on safety biomarkers that can be used to determine if a trial volunteer is running a risk taking an experimental treatment, according to a report in MedPage Today. Creatinine, for example, is often used as a biomarker for damage being done to the body. But developers and the agency will seek more sensitive biomarkers that can be used as a better safety flag. That will give developers a clear signal of the safety standards they need to meet as well as better tools to do it with.
"Being able to be assured that the biomarkers are reliably telling us the truth--that it means that there is kidney injury when the biomarker signals that, and there is not kidney damage when the kidney doesn't signal that" is crucial, said Marc Walton, associate director in the office of translational sciences at FDA.
Moving on to surrogate endpoints that can be used to demonstrate efficacy, though, is likely to prove a much greater obstacle. These so-called surrogates would go a long way to reducing trial costs, but Walton cautions that regulators aren't likely to embrace them without considerable evidence that they work as advertised.
- here's the report from MedPage Today