WASHINGTON (AP) – Concerned about a system in which more than nine out of every 10 experimental drugs fail when tested in humans, the Food and Drug Administration issued suggestions Thursday on how researchers can more efficiently evaluate the promise of new laboratory discoveries.

The vast majority of drug candidates fail once they’re tested on humans, invariably for safety or efficacy reasons difficult to predict based on initial experiments done in test tubes and on animals. That can waste significant amounts of time and money, slowing the process of developing new drugs.

The goal of the new approaches being floated by the FDA is to guide researchers on methods of identifying early on those drug candidates that are most likely to succeed once early testing in humans begins. Those so-called exploratory investigational new drug studies typically involve very limited numbers of subjects given small amounts of a drug for brief periods.

The new advice also offers approaches for safely producing in laboratories the small batches of drugs needed for initial tests. Given the limited scope of early trials, the manufacturing requirements should be less burdensome than they are for drugs being prepared for the larger-scale trials that eventually can involve thousands of patients, health officials told reporters Thursday.

“This will allow us to test a broader variety of compounds in people early and pick the best ones for going forward,” said Dr. Janet Woodcock, the FDA’s deputy commissioner for operations.

Dr. Andrew von Eschenbach, the acting FDA commissioner, said “rapid does not mean reckless” in streamlining the drug development process.

But Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the proposals would save companies money at the expense of increased risk to the human subjects of trials.

“This is really a proposal – as far as I can see, an invitation – for industry to lower the costs of preclinical trials and increase the potential risk for people who will be subjects in these, quote, ‘preclinical studies,”‘ Wolfe said.

The new documents are part of what the regulatory agency calls its critical path initiative, which refers to the journey a drug takes from laboratory to patient. The initiative, introduced in 2004, aims to improve the efficiency and safety of the development of drugs and other medical products.

The recommendations will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs, said Mike Leavitt, secretary of the Department of Health and Human Services.

The documents also explain the flexibility in the amount of data, including provisions for less exhaustive animal testing, the FDA requires from researchers before it will allow them to undertake early stage testing in humans. That, too, in theory could speed the drug development process.

Those requirements represent one of the biggest barriers faced by researchers in their attempts to move a new discovery from the lab into human testing, von Eschenbach said.

Taking full advantage of the flexibility FDA offers could spur researchers in the development of tailor-made drugs for individual patients, he added.

“It’s going to save a lot of time in eliminating those things that don’t work in patients from those that do,” said Dr. Steven Rosenfeld, chief of surgery at the National Cancer Institute.

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