Jack Armitage

ECONOMIC ANALYSIS IN PHASE III CLINICAL CANCER TRIALS

Randomized phase III clinical trials provide important information on the efficacy of new pharmaceutical agents for cancer patients. Policy makers are showing increased interest in both economic and clinical data on new agents in order to approve pharmaceuticals for widespread use, and clinical trials have been viewed as the proper setting to evaluate these outcomes for new agents. With the recent approval of new pharmaceutical agents that have high costs, early assessments of economic benefit have taken on larger importance to physicians and patients. The integration of economic and clinical analysis in phase III clinical trials raises methodological and practical issues related to study design, collection of data on resource utilization, and generalizability of data to other settings. In this paper, we review these issues and discuss their relationship to clinical trials for new pharmaceutical products.

Peer review effectiveness

Purpose – To assess peer review effectiveness by identifying potential loopholes that could lead to Type II errors, that is, loopholes that would allow reviewed firms to pass their peer review when they should not pass.Design/methodology/approach – A questionnaire was mailed to a random sample of 500 CPA firms in the USA. A total of 200 responses were received for a 40 percent response rate.Findings – This study found many firms allowed to self‐select will select their engagements least likely to contain violations, allowing firms to review engagements selected before submitting them to the reviewer is a problem, 1 percent of respondent firms neglected to fulfill relevant professional standards because the firms felt there was an insignificant chance of the engagements being selected, and 9 percent of respondent firms indicated they had duplicated work papers and may not have actually done required procedures.Research limitations/implications – If improprieties were occurring within respondent firms, thos...