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Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized,

Jennifer K Logan1, Chad Tang1, Zhongxing Liao1

  • 1Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.

International Journal of Radiation Oncology, Biology, Physics
|March 1, 2017
PubMed
Abstract

Insights

Early trial information presentation significantly boosts patient enrollment in oncology clinical trials. This strategy improves accrual rates without altering study design, even in challenging settings.

Area of Science:

  • Oncology
  • Clinical Trials
  • Radiation Therapy

Background:

  • Maximizing patient enrollment in clinical trials presents significant challenges.
  • Limited research exists on enrollment barriers and alternative study designs to improve patient accrual.

Purpose of the Study:

  • To analyze barriers to clinical trial enrollment, focusing on the influence of timing.
  • To evaluate the efficacy of early trial information presentation in improving accrual rates for oncology trials.

Main Methods:

  • Analysis of patient enrollment data from three prospective, randomized oncology trials (NSCLC, esophageal cancer).
  • Screening of eligible patients, recording patient characteristics, and trial presentation timing (appointment number).
  • Statistical analysis including Fisher's exact test, Student's t tests, and multivariate analysis to compare enrolled vs. refusal patients.

Main Results:

  • A 52% enrollment success rate was observed among 309 eligible patients approached.
  • Earlier presentation of trial information was the most significant factor influencing enrollment success across all three protocols.
  • No other patient characteristics or factors significantly impacted enrollment rates.

Conclusions:

  • Enrollment rates in randomized control trials can be improved, even in difficult accrual settings.
  • Presenting trial information earlier to patients is a key factor for successful accrual.
  • This strategy can overcome enrollment barriers without compromising the integrity of trial design.

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