ArticleClinical cancer research : an official journal of the American Association for Cancer Research2010
Phase III clinical trial development: a process of chutes and ladders.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed.
- Randomized phase III trial of consolidation therapy with bortezomib-lenalidomide-Dexamethasone (VRd) vs bortezomib-dexamethasone (Vd) for patients with multiple myeloma who have completed a dexamethasone based induction regimen.Blood cancer journal · 2016Trial
- Feasibility of decentralized real-world monitoring of SARS-CoV-2 booster vaccines and COVID-19 outcomes in myeloma.Blood advances · 2026Observational
- Artificial Intelligence and the future of clinical trials.Contemporary clinical trials communications · 2025Article
- How to Build a Successful Phase I Clinical Trials Unit: Lessons Based on the MD Anderson Cancer Center Experience.Journal of immunotherapy and precision oncology · 2024Article
- New Anticancer Drugs: Reliably Assessing "Value" While Addressing High Prices.Current oncology (Toronto, Ont.) · 2024Article
- Jin-Gu-Lian Capsule Did Not Significantly Improve Clinical Value in Rheumatoid Arthritis Therapy: A Real-World Study.Journal of inflammation research · 2024Article
- Integrating Systematic Reviews into Supportive Care Trial Design: The Rethinking Clinical Trials (REaCT) Program.Current oncology (Toronto, Ont.) · 2022Review
- Applying concepts from "rapid" and "agile" implementation to advance implementation research.Implementation science communications · 2022Article
- Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.Ecancermedicalscience · 2022Article
- Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers.JCO oncology practice · 2021Article
- An investigation into the factors affecting investigator-initiated trial start-up in Ireland.Trials · 2020Article
- Current models, challenges and best practices for work conducted between European academic cooperative groups and industry.ESMO open · 2020Article
- From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Review
- Approaches to modernize the combination drug development paradigm.Genome medicine · 2016Review
- The Blood and Marrow Transplant Clinical Trials Network: An Effective Infrastructure for Addressing Important Issues in Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016Review
- Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials.Clinical trials (London, England) · 2014Article
- Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials.Journal of the National Cancer Institute · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
purposeThe Institute of Medicine report on cooperative groups and the National Cancer Institute (NCI) report from the Operational Efficiency Working Group both recommend changes to the processes for opening a clinical trial. This article provides evidence for the need for such changes by completing the first comprehensive review of all the time and steps required to open a phase III oncology clinical trial and discusses the effect of time to protocol activation on subject accrual.
methodsThe Dilts and Sandler method was used at four cancer centers, two cooperative groups, and the NCI Cancer Therapy Evaluation Program. Accrual data were also collected.
resultsOpening a phase III cooperative group therapeutic trial requires 769 steps, 36 approvals, and a median of approximately 2.5 years from formal concept review to study opening. Time to activation at one group ranged from 435 to 1,604 days, and time to open at one cancer center ranged from 21 to 836 days. At centers, group trials are significantly more likely to have zero accruals (38.8%) than nongroup trials (20.6%; P < 0.0001). Of the closed NCI Cancer Therapy Evaluation Program-approved phase III clinical trials from 2000 to 2007, 39.1% resulted in <21 accruals.
conclusionsThe length, variability, and low accrual results demonstrate the need for the NCI clinical trials system to be reengineered. Improvements will be of only limited effectiveness if done in isolation; there is a need to return to the collaborative spirit with all parties creating an efficient and effective system. Recommendations put forth by the Institute of Medicine and Operational Efficiency Working Group reports, if implemented, will aid this renewal.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.