SIR â€“ Your leader on the reform of pharmaceutical regulations in America maintains that safety concerns must be addressed, but why assume that the government will do a better job than independent players (â€œFrom bench to bedsideâ€, June 30th)? In the United States private agencies ensure quality assessment (including off-label use and risks missed by the government) in a speedier way than the Food and Drug Administration.
As Peter Pitts, a former associate commissioner at the FDA, has shown, there is no direct link between additional clinical trials and safer medicines. The length of the FDA approval process has doubled since the 1960s as have the financial costs since the late 1980s. Moreover, the number of clinical trials doubled between 1977 and 1995 and the number of patients tripled. Yet in the past 40 years the share of medicines withdrawn from the market has remained constant.
Centre for the New Europe
The rest of the story is that the science of clinical trials needs updating. If we want to truly move into the era of personalized medicine, we need adaptive clinical trials that can look more precisely at sub-populations.
"Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.