Optimization of Comparative Efficacy Trials

  • August 2012
  • -
  • SCRIP Insights
  • -
  • 31 pages

Clinicians and patients want to be able to compare new drugs with those already available to inform evidence-based medicine, and reimbursement authorities require comparative data to support their decisions. This report discusses the optimization of comparative efficacy trials, with particular attention to the question of comparator selection.Understand the role that comparative efficacy plays in the evaluation of new drugs.Identify decision-making processes for guiding key choices in the design of pivotal comparative efficacy trials.Understand the importance of comparator selection and the consequences of later disagreements with external authorities.Review the factors that need to be considered in making a comparator selection.Assess the opportunity for gaining input from drug evaluation authorities.The choice of active control group for a comparative trial can be difficult due to variation in the standard of care across different geographic regions and changing medical practicesNumerous recent appraisals by the UK’s National Institute for Health and Clinical Excellence (NICE) and Germany’s Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) have demonstrated the critical stance that is being readily taken by these bodies with regard to comparator selection.Scientific advice from regulators and, where possible, from health technology assessors or reimbursement authorities can be extremely useful in guiding clinical development planning, especially in the choice of comparator.How should an active comparator and other features of comparative efficacy trials be chosen?What decision-making techniques are available to those designing comparative efficacy trials?Can the range of comparators be expected to extend beyond pharmaceutical interventions?To what extent have drug evaluation committees shown flexibility in disagreements about the optimum comparator?Which regulatory and reimbursement authorities are willing to offer scientific advice in the design of a comparative efficacy trial?

Table Of Contents


About the author
•Disclaimer
EXECUTIVE SUMMARY
•Trial optimization
Introduction
•Key points regarding comparative efficacy trials
Trial optimization
•Introduction
•Recent examples of challenges in comparator selection
- NICE criticizes Novartis’s choice of comparator for Gilenya
- AstraZeneca’s Faslodex rejected by NICE on the basis of indirect comparison
- IQWiG and NICE judge GlaxoSmithKline’s Benlysta to have been inadequately compared
- Biogen Idec’s Fampyra highlights challenges of comparison with non-pharmacological treatment
- IQWiG disagrees with GlaxoSmithKline regarding comparators for Trobalt
- Eisai’s Halaven considered inadequately compared despite following EMA protocol
- Comparison with experimental treatments not demanded by the FDA but view of reimbursers is uncertain
- A late-arriving statin has adequate comparator data for regulatory approval but proving differentiation is another matter
•Selection of active control group for the comparative trial
- Use of existing knowledge
- Decision-making techniques
- Reflecting on the range of interventions
•Patient populations, outcomes, and other study variables
•Modeling and simulation in clinical trial design
•Scientific advice
- The NICE scientific advice process
- Multi-stakeholder dialogue
•Conclusions
Appendix
•Methodology
- Research methodology
- Acknowledgements
•Glossary
•Abbreviations
•References

TABLES

•Table: Statins available in the US
•Table: Pharmacometric consultancies

FIGURES

•Figure: Factors determining choice of active control in a clinical trial



Companies Mentioned
GlaxoSmithKline Plc, Hutchison 3G UK Limited, Informa plc, Janssen Pharmaceuticals, Inc.

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