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Title: Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

Abstract

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4more » vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.« less

Authors:
; ;  [1];  [2];  [3];  [4];  [1];  [3];  [1];  [1]
  1. Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
  2. Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
  3. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
  4. Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
Publication Date:
OSTI Identifier:
22649866
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 97; Journal Issue: 4; Other Information: Copyright (c) 2016 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CLINICAL TRIALS; DIFFUSION BARRIERS; LUNGS; MULTIVARIATE ANALYSIS; NEOPLASMS; PATIENTS; RADIOTHERAPY

Citation Formats

Logan, Jennifer K., Tang, Chad, Liao, Zhongxing, Lee, J. Jack, Heymach, John V., Swisher, Stephen G., Welsh, James W., Zhang, Jianjun, Lin, Steven H., and Gomez, Daniel R., E-mail: dgomez@mdanderson.org. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials. United States: N. p., 2017. Web. doi:10.1016/J.IJROBP.2016.11.035.
Logan, Jennifer K., Tang, Chad, Liao, Zhongxing, Lee, J. Jack, Heymach, John V., Swisher, Stephen G., Welsh, James W., Zhang, Jianjun, Lin, Steven H., & Gomez, Daniel R., E-mail: dgomez@mdanderson.org. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials. United States. doi:10.1016/J.IJROBP.2016.11.035.
Logan, Jennifer K., Tang, Chad, Liao, Zhongxing, Lee, J. Jack, Heymach, John V., Swisher, Stephen G., Welsh, James W., Zhang, Jianjun, Lin, Steven H., and Gomez, Daniel R., E-mail: dgomez@mdanderson.org. Wed . "Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials". United States. doi:10.1016/J.IJROBP.2016.11.035.
@article{osti_22649866,
title = {Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials},
author = {Logan, Jennifer K. and Tang, Chad and Liao, Zhongxing and Lee, J. Jack and Heymach, John V. and Swisher, Stephen G. and Welsh, James W. and Zhang, Jianjun and Lin, Steven H. and Gomez, Daniel R., E-mail: dgomez@mdanderson.org},
abstractNote = {Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.},
doi = {10.1016/J.IJROBP.2016.11.035},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 4,
volume = 97,
place = {United States},
year = {Wed Mar 15 00:00:00 EDT 2017},
month = {Wed Mar 15 00:00:00 EDT 2017}
}