Hohman on Clinical Research

It takes years for even the most promising experimental drugs to transition through laboratory development, clinical trials, and FDA evaluation in order to reach patients. FDA, collaborating with advocacy organizations and industry, has implemented numerous measures to accelerate drug development and evaluation. This first occurred through the Prescription Drug User Fee Act, which increased FDA resources and has been renewed five times since 1992, and progressively since then a host of expedited approval mechanisms has ensured that FDA drug evaluation reflects the current state of drug development science.   These include Accelerated Approval, which allows for the approval of a drug based on a surrogate endpoint likely to predict long term benefit, and the Breakthrough Therapies designation, which provides especially promising drug candidates early in their development process with additional FDA attention, communication and flexibility. These programs have significantly improved FDA and industry efficiency, but many patients hoping for life-changing drugs still face a long wait. By participating in clinical trials, patients can accelerate access to new therapies for themselves and for other patients that may one day encounter the same disease. Clinical trials may give patients direct access to cutting-edge drugs that have yet to reach the market. For patients facing conditions without approved treatments or for which new treatments are actively being developed, clinical tr...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news