The Clinical Trials Transformation Initiative: innovation through collaboration

Tenaerts, Pamela; Madre, Leanne K.; Archdeacon, Patrick; Califf, Robert M.

doi:10.1038/nrd4442

Cited by 28 publications

(15 citation statements)

References 4 publications

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“…To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning. These activities were conducted as part of CTTI's mission to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials [18]. We describe our multi-stakeholder effort to develop recommendations and tools for more effective clinical trial planning in order to reduce barriers to recruitment.…”

Section: Introductionmentioning

confidence: 99%

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

Huang

Bull

McKee

et al. 2018

Contemporary Clinical Trials

227

171

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Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement.

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Section: Introductionmentioning

confidence: 99%

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

Huang

Bull

McKee

et al. 2018

Contemporary Clinical Trials

227

171

View full text Add to dashboard Cite

show abstract

“…One of these resources is the Clinical Trials Transformation Initiative (CTTI), a public-private partnership founded by the US Food and Drug Administration (FDA) and Duke University to improve the quality and efficiency of clinical trials. They examine and advance recommendations related to topics such as quality, risk management in trials, large simple trials, and central IRBs, among many others (11). The existing literature contains reviews of adaptive designs (12), discussion of potential benefits and drawbacks (13–15), and a description of adaptive sample calculations (16).…”

Section: Introductionmentioning

confidence: 99%

Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process—Findings from a qualitative study

Guetterman¹,

Fetters²,

Legocki³

et al. 2015

Clinical Research and Regulatory Affairs

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Context The context for this study was the Adaptive Designs Advancing Promising Treatments Into Trials (ADAPT-IT) project, which aimed to incorporate flexible adaptive designs into pivotal clinical trials and to conduct an assessment of the trial development process. Little research provides guidance to academic institutions in planning adaptive trials. Objectives The purpose of this qualitative study was to explore the perspectives and experiences of stakeholders as they reflected back about the interactive ADAPT-IT adaptive design development process, and to understand their perspectives regarding lessons learned about the design of the trials and trial development. Materials and methods We conducted semi-structured interviews with ten key stakeholders and observations of the process. We employed qualitative thematic text data analysis to reduce the data into themes about the ADAPT-IT project and adaptive clinical trials. Results The qualitative analysis revealed four themes: education of the project participants, how the process evolved with participant feedback, procedures that could enhance the development of other trials, and education of the broader research community. Discussion and conclusions While participants became more likely to consider flexible adaptive designs, additional education is needed to both understand the adaptive methodology and articulate it when planning trials.

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“…Several initiatives have been established in recent years to remedy this situation. In the USA, Duke University and the Food and Drug Administration established CTTI, the Clinical Trials Transformation Initiative (Tenaerts et al ., ). CTTI's mission is “to promote practices that will increase the quality and efficiency of clinical trials,” with the aim to create a clinical trials system that is “patient centered and efficient, enabling reliable and timely access to evidence‐based prevention and treatment options.” The initiative has generated evidence and formulated recommendations, for example, to streamline risk‐based trial monitoring and the ethical review process.…”

Section: From Efficacy To Relative Effectiveness In the Real Worldmentioning

confidence: 97%

GetReal: from efficacy in clinical trials to relative effectiveness in the real world

Egger

Moons

Fletcher

2016

Research Synthesis Methods

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The GetReal consortium ("incorporating real-life data into drug development") addresses the efficacy-effectiveness gap that opens between the data from well-controlled randomized trials in selected patient groups submitted to regulators and the real-world evidence on effectiveness and safety of drugs required by decision makers. Workpackage 4 of GetReal develops evidence synthesis and modelling approaches to generate the real-world evidence. In this commentary, we discuss how questions change when moving from the well-controlled randomized trial setting to real-life medical practice, the evidence required to answer these questions, the populations to which estimates will be applicable to and the methods and data sources used to produce these estimates. We then introduce the methodological reviews written by GetReal authors and published in Research Synthesis Methods on network meta-analysis, individual patient data meta-analysis and mathematical modelling to predict drug effectiveness. The critical reviews of key methods are a good starting point for the ambitious programme of work GetReal has embarked on. The different strands of work under way in GetReal have great potential to contribute to making clinical trials research as relevant as it can be to patients, caregivers and policy makers. Copyright © 2016 John Wiley & Sons, Ltd.

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The Clinical Trials Transformation Initiative: innovation through collaboration

Abstract: The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.

Cited by 28 publications

References 4 publications

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process—Findings from a qualitative study

GetReal: from efficacy in clinical trials to relative effectiveness in the real world

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