Navigation Links
Optimization of Comparative Efficacy Trials
Date:9/19/2012

NEW YORK, Sept. 19, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Optimization of Comparative Efficacy Trials

http://www.reportlinker.com/p0968581/Optimization-of-Comparative-Efficacy-Trials.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Discovery_and_Development

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?

 

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.

 

To order this report:

Drug_Discovery_and_Development Industry: Optimization of Comparative Efficacy Trials

Nicolas Bombourg
Reportlinker
Email: nicolasbombourg@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626


'/>"/>
SOURCE Reportlinker
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Leading Researchers Outline Principles for Conduct of Comparative Effectiveness Research
2. Renal Dialysis Equipment Market to 2017- Lower Costs and Similar Efficacy Rates as Hemodialysis to Increase Adoption Rates of Peritoneal Dialysis
3. MedQIA unique CAD algorithm for Quantitation of lung involvement in diffuse lung disease used as treatment efficacy end point in study to be reported at the ERS Annual Conference in Vienna, Austria: September 1-5, 2012
4. Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on Efficacy Results
5. Sosei Group Corporation: Data at ERS Shows Efficacy of Once-daily COPD Portfolio Versus Comparators, Further Establishes Dual-bronchodilator QVA149
6. Marken Acquires European Kit Building Operation From LabCorp Clinical Trials
7. Synteract Sponsoring and Presenting at Outsourcing in Clinical Trials Southeast Conference
8. HIV Vaccine Trials Network Opens Enrollment for Phase 1 Trial of GeoVax Labs Second Generation HIV Vaccine
9. Berg Pharma presents at ASCO, poised to lead field in cancer metabolism with Phase II trials of BPM 31510
10. New Report Shows Ohio Clinical Trials Benefit Patients, the Economy and Science
11. PLC Systems Secures Additional Financing For US Clinical Trials And General Working Capital
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2017)... 22, 2017 Janssen Biotech, Inc. (Janssen) announced ... from the U.S. Food and Drug Administration (FDA) for ... for the treatment of moderately to severely active rheumatoid ... data are needed to further evaluate the safety of ... RA. "We ...
(Date:9/22/2017)... 22, 2017 AVACEN Medical (AVACEN) announced that ... successfully helping those with the widespread pain associated with ... Amanda in Essex, England commented, ... hair, experiencing no sleep at all, tremendous pain, with ... cannot recommend [the AVACEN 100] enough, how this has ...
(Date:9/19/2017)... Ky. , Sept. 19, 2017   ZirMed Inc ... predictive analytics, today announced that it has been ranked #1 ... Black Book™ Rankings 2017 User Survey. ZirMed was ... solution for large hospitals and medical centers over 200 beds ... Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s ... design of the shoulder pad. The shoulder pad provides optimal support and full ... while using cold therapy. By utilizing ice and water that is circulated from an ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: ... develop to enable prevention of a major side effect of chemotherapy in children. ... pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose ...
(Date:10/12/2017)... D.C. (PRWEB) , ... October 12, 2017 , ... Leading ... their peers in Washington, D.C., for the 49th Congress of the International Society ... ., Vice President of the Center for Cancer and Blood Disorders at ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... nation's first interactive health literacy software tool, and the Cancer Patient Education Network ... cancer patient education, today announce a new strategic alliance. , As CPEN’s ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... of California Berkeley, and other leading institutions in announcing the launch of the ... to change the way animals are raised for food. , Founding members of ...
Breaking Medicine News(10 mins):