Abstract 5522: Analysis of recruitment of non small cell lung cancer patients into clinical trials

• Published in: Cancer research (Chicago, Ill.) Vol. 72; no. 8_Supplement; p. 5522
• Main Authors: Joubert, Richard, Bortini, Stefanella, Raeth, Ulrich, Moehler, Thomas
• Format: Journal Article
• Language: English
• Published: 15.04.2012
• ISSN: 0008-5472; 1538-7445
• DOI: 10.1158/1538-7445.AM2012-5522

Abstract Background: Clinical trials are a major step for the assessment of new molecules or novel treatments that may change the medical practice. Accurate estimation of patient recruitment plays a major role when planning clinical trials with new treatment modalities for non-small cell lung cancer (NSCLC) patients. Method: We performed a systematical review of all published results from NSCLC clinical studies in Journal of Clinical Oncology and Journal of Thoracic Oncology between January 2009 and December 2010 by focusing on the parameters considered to be relevant for patient recruitment: number of patients, sites and enrollment period, indication, Phase of trial, type of study sponsor, geographic region, type of drug and line of treatment. Results: Of 104 studies identified within PubMed, data from 51 studies could be integrated into the final analysis. Fifty-three studies were omitted from this analysis as recruitment data were missing. Most of trials were performed in the metastatic or advanced setting. Overall, a mean enrollment of 0.64 Patient/Month/Site (range, 0.02 to 7.14) was estimated and the highest mean recruitment rate estimated was 1.81 Patients/Month/Site corresponding to 9 single-center studies. The mean enrollment rates in Patient/Month/Site were 0.57 for Phase I trials, 0.78 for Phase II trials and 0.33 for Phase III trials. University-sponsored trials were able to enroll patients with the highest mean rate of 1.48 Patient/Month/Site. Trials conducted in only European sites recruited patients with the highest mean rate of 1.40 Patient/Month/Site (8 studies). The majority of the studies evaluated treatments based on targeted therapy alone or combined with cytotoxic chemotherapy. Thirty-five (69%) studies assessed first-line treatment but the highest recruitment rate of 1.02 Patient/Month/Site was estimated for second- and subsequent lines of treatment. The statistically significant differences were mainly found when comparing the mean recruitment rates for (i) the different types of sponsor and (ii) the number of sites involved in the study. These best recruitment rates were found for University driven studies and in single-center trials. Conclusions: Study design aspects as phase I dose escalation and randomization are systematic burden to patient recruitment. Thorough planning of the study to optimize and adapt the treatment concept used in the study and attract the interest of the investigators and patients are key to recruitment. In that respect, phase II trials on targeted agents as single agents or in combination with high potential to impact the standard treatment showed 2-fold higher than mean enrollment rate for multi-center trials. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 5522. doi:1538-7445.AM2012-5522