Related Experiment Video
Updated: Jun 10, 2025
Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Successful completion of large, low-cost randomized cancer trials at an academic cancer center
Andrew J Vickers1, Behfar Ehdaie2, Hanae K Tokita3
1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Background:
Concerns about low accrual have long been a standard part of the discourse on cancer clinical trials, reaching even as far as the news media. Indeed, so many trials are closed before completing accrual that a cottage industry has recently developed creating statistical models to predict trial failure. We previously proposed four methodologic fixes for the current crisis in clinical trials: (1) dramatically reducing the number of eligibility criteria, (2) using data routinely collected in clinical practice for trial endpoints; then lowering barriers to accrual by (3) cluster randomization or (4) staged consent.
Methods:
We report our practical experience of applying these fixes to randomized trials at Memorial Sloan Kettering Cancer Center.
Results:
We have completed seven single-center randomized trials, with several more underway and accruing rapidly, with a total accrual approaching 10,000. Many of the trials have compared surgical interventions, an area where trials have traditionally been hard to complete. Only one of these trials was externally funded. While low costs were possible due to the existing research infrastructure at our institution, such infrastructure is common at major cancer centers.
Conclusions:
Further research on innovative clinical trial designs is warranted, particularly in higher-stakes settings, and in trials of medical and radiotherapy interventions.
Insights
Implementing four innovative strategies significantly improved patient enrollment in cancer clinical trials. These methods address common barriers, making trials more accessible and efficient for patients and researchers.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Low patient accrual is a persistent challenge in cancer clinical trials, often leading to premature closure.
- Statistical models are increasingly used to predict trial failures due to low enrollment.
- Previous research proposed four methodological solutions to enhance clinical trial accrual.
Purpose of the Study:
- To report the practical application of four proposed methodological fixes for improving patient accrual in randomized cancer clinical trials.
- To evaluate the feasibility and success of these innovative trial designs in a real-world setting.
Main Methods:
- Reducing eligibility criteria to broaden patient access.
- Utilizing routine clinical practice data for trial endpoints.
- Employing cluster randomization to increase patient participation.
- Implementing staged consent procedures to streamline enrollment.
Main Results:
- Seven single-center randomized trials were successfully completed, with nearly 10,000 patients accrued across ongoing studies.
- These trials included surgical interventions, historically challenging areas for accrual.
- The majority of trials were not externally funded, indicating cost-effectiveness.
Conclusions:
- The implemented methodological fixes proved effective in enhancing patient accrual for randomized cancer clinical trials.
- Further investigation into innovative trial designs is recommended for medical and radiotherapy interventions.
- The findings suggest that these strategies can be successfully applied in major cancer centers with existing research infrastructure.
More Related Videos
14:14Adaptation of Semiautomated Circulating Tumor Cell CTC Assays for Clinical and Preclinical Research Applications
Published on: February 28, 2014
09:29Development and Maintenance of a Preclinical Patient Derived Tumor Xenograft Model for the Investigation of Novel Anti-Cancer Therapies
Published on: September 30, 2016
