Role of academia, government and pharmaceutical industry in early-phase clinical trials of novel cancer immunotherapies

Abstract

6061 Background: This study was initiated to assess the levels of involvement of Academia, Government and Industry in Phase I and II clinical trials of novel cancer immunotherapies. Methods: Two databases, ClinicalTrials.gov, maintained by National Institutes of Health (NIH), and Cancer.gov, maintained by the National Cancer Institute (NCI), were selected for review on the basis of the number of trials of novel immunotherapies, and the level of information provided. Over the month of July 2003, each database was extensively mined for all Pilot, Phase I, I/II and II trials listed as active, completed or suspended. There were 482 trial records gathered from Cancer.gov, and 600 trial records gathered from ClinicalTrials.gov. The datasets were combined, and duplicate studies were eliminated to yield a final, non-redundant dataset of 758 trials. Results: ClinicalTrials.gov identified Academia/Government collaborations as sponsor of 45% of trials, Government and Industry as sole sponsor in 36% and 10% of trials...