Single pivotal trial can provide clinical evidence of drug efficacy, Sen. Jeffords tells DIA.
This article was originally published in The Tan Sheet
Executive Summary
SINGLE PIVOTAL TRIAL PROVIDES ADEQUATE DRUG APPROVAL BASIS, SEN. JEFFORDS told the plenary session of the Drug Information Association annual meeting in Boston June 8. "We expect that FDA will move away from the rote assumption that every product application must have two clinical trials," Sen. James Jeffords (R-Vt.) said. Instead, each application should be approached "with an open mind. The power of today's clinical trials and research technique can often provide the evidence needed in just one trial," he observed.