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Table 1 Final thematic framework applied to the data collected from interview and focus groups HTA; health technology assessment

From: How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis

Theme Subtheme Description Example
Methodological Development Important statistical issues to consider when developing the use of adaptive designs and health economics in HTA How to handle bias in the analysis of group sequential trials Advantages and disadvantages of using adaptive designs and health economics together in clinical trials Issues with cost data that need to be considered when developing the methods
  Current use How are adaptive designs, economic evaluations and value of information analysis methods currently used in practice and what are their advantages and disadvantages? Use of value of information analysis methods is limited in practice because it is often perceived as complicated
  Experience and knowledge What experience and knowledge do the participants have of these methods and where has this come from? Members of the public may rely on the media for information about healthcare decision-making
Ethical Planning Ethical issues that should be considered when planning trials (before they begin) using adaptive designs and health economics The motivations of patients for being involved in trials can differ, and so using cost-effectiveness as part of a trial may or may not influence whether people want to take part The aims of a clinical trial from all stakeholder perspectives (when talking at a societal/personal level rather than statistical) The context where these methods are appropriate from an ethical point of view, e.g. end of life Historical case studies have influenced changes in policy and how we run clinical trials, and methods need to reflect this
  Implementation and conduct Ethical issues that should be considered when conducting or implementing trials using adaptive designs and health economics in the real world (during the trial) The methods could allow the assumption of equipoise to be compromised at interim analyses Protecting participants in trials if the trial stops How the DMEC would be composed in these trials
  Documenting and reporting Ethical issues that should be considered when writing documentation for trials using adaptive designs and health economics (not just reporting after the trial has ended) Informed consent is key to any trial, and providing participants and potential participants with the appropriate level of information is important
Practical Planning Practical issues to consider when planning a trial/before conducting a trial with an adaptive design and health economic analysis Who will need training and what sort of training would be appropriate? The level of complexity in the methods needs to be acceptable to funding panels reviewing grant applications and the agencies reviewing the evidence The role of public involvement Context where you could implement these methods from a practical point of view
  Implementation and conduct Practical issues to consider when conducting or implementing a trial with an adaptive design and health economic analysis How should interim decision-making be handled and what influence should competing factors have? Issues with cost data that might impact the practical application of this work Development of guidance documents for researchers implementing these methods
  Documenting and reporting Practical issues to consider when reporting and writing documentation for a trial with an adaptive design and health economic analysis (not just reporting when trial has ended) Documentation required throughout the trial process such as what to include in a protocol and analysis plans (pre-specification) Additional reporting requirements when publishing this research Reporting requirements for interim analyses
  1. The framework was informed by existing literature [35, 4457], discussions with the public advisory group and early data collected