Improving the impact of clinical research: A systematic analysis of kidney cancer trials.

Abstract

6051 Background: Clinical trials are essential to advancing cancer care, but the means to evaluate and improve the portfolio have been lacking. This study analyzes the renal cell carcinoma (RCC) trial portfolio using the database for the Aggregate Analysis of ClinicalTrials.gov. As RCC is an area of promise, what insights can an evaluation of the portfolio provide? Methods: 40,970 clinical studies registered with ClinicalTrials.gov between October 2007 and September 2010 were aggregated by specialty using MeSH terms and submitted conditions. 8,942 oncology trials were identified and categorized by cancer type. 108 trials opening in October 2007 or later were identified as evaluating treatments for RCC. Descriptive statistics were used to characterize trial design, study agent(s), accrual and sponsorship. Results: 52 trials (48%) assessed agents already recommended as 1st or 2nd-line treatments in the National Comprehensive Cancer Network (NCCN) RCC Guidelines at the time of study initiation and 19 (18%) studied other FDA-approved treatments. 37 trials (34%) included a novel (non-FDA approved) agent or vaccine. Total anticipated or actual accrual was 12,753, with 50% accrued/accruing to trials of only NCCN agents, 34% to novel agents and 16% to other FDA-approved agents. Industry was identified as a sponsor or collaborator in 48% of trials assessing only NCCN agents, 73% of novel agent trials and 53% of other FDA-approved agent trials. As shown in the table, a minority of trials were randomized, blinded or late-phase (Phase III or IV), regardless of approval status of study agent. Conclusions: The majority of new studies and accrual in RCC assess questions of treatment sequence and setting for established therapies, many of which lack rigorous design. Across the portfolio, studies are predominantly industry sponsored. Optimizing clinical research includes increasing studies of novel therapeutics and improving the comparative effectiveness research portfolio by increasing utilization of pragmatic designs, registries and late-phase programs. [Table: see text]