Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

AbstractAdaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.

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Technological Research on CPC Product Development Process Based on Extenics

Applied Mechanics and Materials ◽

10.4028/www.scientific.net/amm.423-426.1831 ◽

2013 ◽

Vol 423-426 ◽

pp. 1831-1836

Author(s):

Liu Lei ◽

Fen Fen Yu

Keyword(s):

Product Development ◽

Manufacturing Industry ◽

Development Process ◽

Adaptive Design ◽

Product Development Process ◽

Prototype System ◽

Model Design ◽

Processing Mode ◽

Theoretical System ◽

New Ideas

Experts hold the same opinion that the main processing mode of manufacturing industry in 2020 is based on CPC. Manufacturing industry information that CPC stands for is a significant signal of comprehensive competition. The paper suggests applying the extenics to the field of product development process ,setting up CPCs theoretical system and overall framework supporting technology, supporting the environment through supporting environment of simulation, developing a way in which an enterprise designs innovatively and adaptively for the product development process. And on the basis, a prototype system has been developed based on a web model to drive a rapid design, optimization and management of product development process of enterprises, which provides new ideas, methods and tools for enterprises to initiate the innovative model design and adaptive design for product development process.

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The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

10.21203/rs.2.9725/v1 ◽

2019 ◽

Cited By ~ 1

Author(s):

Munyaradzi Dimairo ◽

Philip Pallmann ◽

James Wason ◽

Susan Todd ◽

Thomas Jaki ◽

...

Keyword(s):

Clinical Trials ◽

Adaptive Design ◽

Randomised Trial ◽

Adaptive Designs ◽

Future Research ◽

Randomised Trials ◽

Public And Private ◽

Key Stakeholders ◽

Potential Benefits ◽

Explanatory Text

Abstract Background Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised. Methods This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 Statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process. Results The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist is comprised of seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text. Conclusions The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.

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The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Trials ◽

10.1186/s13063-020-04334-x ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 3

Author(s):

Munyaradzi Dimairo ◽

◽

Philip Pallmann ◽

James Wason ◽

Susan Todd ◽

...

Keyword(s):

Adaptive Design ◽

Adaptive Designs ◽

Randomised Trials

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A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network

Clinical Trials ◽

10.1177/1740774516688900 ◽

2017 ◽

Vol 14 (3) ◽

pp. 246-254 ◽

Cited By ~ 3

Author(s):

Samkeliso C Mawocha ◽

Michael D Fetters ◽

Laurie J Legocki ◽

Timothy C Guetterman ◽

Shirley Frederiksen ◽

...

Keyword(s):

Clinical Trials ◽

Conceptual Model ◽

Development Process ◽

Adaptive Design ◽

Research Network ◽

Design Development ◽

Open Communication ◽

Statistical Complexity ◽

Key Stakeholders ◽

Adaptive Clinical Trials

Background: Adaptive 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. Methods: We 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. Results: Four 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. Conclusion: The 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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