Efficacy standards are imbalanced on the risk-averse side for most standard drugs and facilitative only for some priority drugs, Carl Peck, director of the Georgetown University Center for Drug Development Science, and former FDA Center for Drug Evaluation and Research head, told the Health Industry Group Purchasing Association's annual legislative summit last month. Standards now used by the US Food and Drug Administration favor safety at the expense of facilitation, discourage efficiency and innovation and lead to imprecise drug labels, he said.
Modern NDAs are suboptimal because they are massive, costly in time and money for industry, challenging and costly for the FDA to review, excessive, inefficient and poorly informative, he said. The industry feels they are suboptimal because they are redundant international requirements, while the FDA blames unsuccessful or failed studies. Still others blame suboptimal science and science management. The policy of reviewing data on the basis of intent-to-treat ignores dropouts, missed dosages, incorrect diagnoses and the like, he said; this method tests prescribing policy, not the true effects of the drug.
He suggested abandoning as a sole or primary method of analysis intent-to-treat, which leads to inaccurate efficacy and toxicity findings and inaccurate labels, and stressing instead state-of-the-art science. One well-controlled clinical trial could be backed up with confirmatory evidence based on a whole knowledge base. These approaches are contained in many FDA reform plans, and would decrease the quantity while improving the quality of the data to the FDA. As industry moves from the empirical to the mechanical base for drug development, he suggested it borrows from other industries and uses computer simulation in trial design as well as drug development.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze