Real-World Clinical Trials Resources

Resources

 

General Information

What are real-world (pragmatic) clinical trials?
  • A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers
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  • What Is a Pragmatic Clinical Trial?
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  • Pragmatic clinical trials
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  • Evidence-based decision-making for primary care: The interpretation and role of pragmatic trials
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  • GetReal project on Real World Evidence (RWE)
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  • NIH Collaboratory - Rethinking Clinical Trials
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  • Rheumatoid arthritis patients treated in trial and real world settings: comparison of randomized trials with registries
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  • The PRECIS-2 tool: designing trials that are fit for purpose
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    Patient-oriented research
  • Raju Kucherlapati talks about personalised medicine: breathing new life into old drugs
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  • Patient-centered medicine and patient-oriented research: improving health outcomes for individual patients
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  • Patient-oriented research: principles and new approaches to training
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  • Patient-Centeredness in the Design of Clinical Trials
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  • CIHR Strategy for Patient-Oriented Research
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  • Patient-Centered Outcomes Research Institute (PCORI)
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  • BC SUPPORT Unit Online Resources Page
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    Stakeholder engagement
  • US cancer groups call for more diverse populations to be included in trials
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  • Public involvement in the design and conduct of clinical trials
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  • Reporting guidelines for Patient/Public Involvment in Research
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  • Patient and public involvement in the design of clinical trials: An overview of systematic reviews
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    Data sharing
  • Whose Data Are They Anyway? Can a Patient Perspective Advance the Data-Sharing Debate?
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  • Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors
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    Methods

    Planning
    Outcome selection:
  • Surrogate endpoints in clinical trials: Definition and operational criteria
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  • Issues affecting the selection of participation measurement in outcomes research and clinical trials
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    Design strategies:
  • Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both
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  • Optimization of adaptive designs: efficiency evaluation
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  • Bayesian randomized clinical trials: From fixed to adaptive design
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  • Statistical considerations on design and analysis of bridging and multiregional clinical trials
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  • Adaptive design methods in clinical trials – a review
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    Specific designs:
  • The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting
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  • How to design efficient cluster randomised trials
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    Incorporating values
    Content to come.
    Incorporating prior information:
  • A valid and reliable belief elicitation method for Bayesian priors
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  • Methods for eliciting expert opinion to inform health technology assessment
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    Conduct
    Recruitment and consent 
  • Influence of Clinical Communication on Patients' Decision Making on Participation in Clinical Trials
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  • The likelihood of participation in clinical trials can be measured: the Clinical Research Involvement Scales
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  • Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial
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  • Maximising Recruitment to Randomised Controlled Trials: The Role of Qualitative Research to Inform Recruitment Challenges
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  • Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches
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  • A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented
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    Data collection
  • Content to come.
  • Data monitoring
  • Data monitoring committees: Promoting best practices to address emerging challenges
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  • On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials
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    Data analysis
  • A Bayesian prediction model between a biomarker and the clinical endpoint for dichotomous variables
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  • An overview of statistical planning to address subgroups in confirmatory clinical trials [Review]
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  • Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines
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  • Practical Guidelines for Multiplicity Adjustment in Clinical Trials
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  • Different methods to analyze stepped wedge trial designs revealed different aspects of intervention effects.
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  • Simple Estimation of Patient-Oriented Effects From Randomized Trials: An Open and Shut CACE
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  • Per-Protocol Analyses of Pragmatic Trials
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    Dissemination/KT

  • Assessing the impact of healthcare research: A systematic review of methodological frameworks
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    Real World Clinical Trial Examples 

  • Ringer's Lactate Versus Normal Saline in Urgent Cesarean Delivery in a Resource-Limited Setting: A Pragmatic Clinical Trial
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