A call to restructure the drug development process: Government over-regulation and non-innovative late stage (Phase III) clinical trials are major obstacles to advances in health care

Abstract

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I-IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the "environment of knowledge" about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II dose-ranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care.

Additional safety risk to exceptionally approved drugs in Europe?

“…However, Boon et al included in their assessment all withdrawals, not discriminating between withdrawals due to safety issues and withdrawals for commercial reasons. Our finding that EC/CA drugs that were approved with more limited clinical data sets are as safe as drugs approved with the standard procedure seems at odds with the current societal demand for more pre-approval ascertainment of harms and benefits of new drugs [10,11,27,28]. This finding has important societal implications.…”