Successful completion of large, low-cost randomized cancer trials at an academic cancer center Journal Article
| Authors: | Vickers, A. J.; Ehdaie, B.; Tokita, H. K.; Nelson, J.; Matros, E.; Pusic, A. L.; D’Angelica, M. |
| Article Title: | Successful completion of large, low-cost randomized cancer trials at an academic cancer center |
| Abstract: | 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. © The Author(s) 2024. |
| Keywords: | treatment outcome; clinical practice; pancreaticoduodenectomy; quality control; prediction; health program; questionnaire; cancer center; electronic medical record; health care system; drug therapy; statistical model; clinical trials; clinical examination; sample size; consent; cancer; human; article; academic cancer center; cluster randomization; surgery research; large successful completion; low cost randomized cancer trial |
| Journal Title: | Clinical Trials |
| Volume: | 22 |
| Issue: | 1 |
| ISSN: | 1740-7745 |
| Publisher: | Sage Publications |
| Date Published: | 2025-02-01 |
| Start Page: | 36 |
| End Page: | 44 |
| Language: | English |
| DOI: | 10.1177/17407745241284044 |
| PUBMED: | 39410769 |
| PROVIDER: | scopus |
| PMCID: | PMC11810578 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledge in the PDF -- Corresponding authors is MSK author: Andrew J Vickers -- Source: Scopus |
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