ArticleClinical trials (London, England)2017
A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.
Article in Clinical trials (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Review
- Comparison of Bayesian vs Frequentist Adaptive Trial Design in the Stroke Hyperglycemia Insulin Network Effort Trial.JAMA network open · 2022Article
- Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care: A systematic review.Contemporary clinical trials communications · 2022Review
- Bayesian clinical trials at The University of Texas MD Anderson Cancer Center: An update.Clinical trials (London, England) · 2019Article
- Article
- Using Adaptive Designs to Avoid Selecting the Wrong Arms in Multiarm Comparative Effectiveness Trials.Statistics in biopharmaceutical research · 2019Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundAdaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials.
methodsWe used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model.
resultsFour major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials.
conclusionThe Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.
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