Literature DB >> 27256477

Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework.

Oriana Ciani1, Marc Buyse2, Mike Drummond3, Guido Rasi4, Everardo D Saad5, Rod S Taylor6.   

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Year:  2016        PMID： 27256477     DOI： 10.1038/nrd.2016.81

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  10 in total

1.  Users' guides to the medical literature: XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points. Evidence-Based Medicine Working Group.

Authors:  H C Bucher; G H Guyatt; D J Cook; A Holbrook; F A McAlister
Journal:  JAMA       Date:  1999-08-25       Impact factor: 56.272

Review 2.  Biomarkers and surrogate end points--the challenge of statistical validation.

Authors:  Marc Buyse; Daniel J Sargent; Axel Grothey; Alastair Matheson; Aimery de Gramont
Journal:  Nat Rev Clin Oncol       Date:  2010-04-06       Impact factor: 66.675

3.  Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.

Authors:  Nicholas S Downing; Harlan M Krumholz; Joseph S Ross; Nilay D Shah
Journal:  Nat Rev Drug Discov       Date:  2015-10-05       Impact factor: 84.694

4.  Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation.

Authors:  Tomasz Burzykowski; Marc Buyse
Journal:  Pharm Stat       Date:  2006 Jul-Sep       Impact factor: 1.894

5.  Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada.

Authors:  Fiona M Clement; Anthony Harris; Jing Jing Li; Karen Yong; Karen M Lee; Braden J Manns
Journal:  JAMA       Date:  2009-10-07       Impact factor: 56.272

Review 6.  Surrogate end points in clinical trials: are we being misled?

Authors:  T R Fleming; D L DeMets
Journal:  Ann Intern Med       Date:  1996-10-01       Impact factor: 25.391

7.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

Review 8.  Complete cytogenetic response and major molecular response as surrogate outcomes for overall survival in first-line treatment of chronic myelogenous leukemia: a case study for technology appraisal on the basis of surrogate outcomes evidence.

Authors:  Ciani Oriana; Hoyle Martin; Pavey Toby; Cooper Chris; Garside Ruth; Rudin Claudius; Taylor Rod
Journal:  Value Health       Date:  2013 Sep-Oct       Impact factor: 5.725

Review 9.  Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.

Authors:  Oriana Ciani; Sarah Davis; Paul Tappenden; Ruth Garside; Ken Stein; Anna Cantrell; Everardo D Saad; Marc Buyse; Rod S Taylor
Journal:  Int J Technol Assess Health Care       Date:  2014-07       Impact factor: 2.188

Review 10.  Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study.

Authors:  Oriana Ciani; Marc Buyse; Ruth Garside; Toby Pavey; Ken Stein; Jonathan A C Sterne; Rod S Taylor
Journal:  BMJ       Date:  2013-01-29
  10 in total
  6 in total

1.  European union regulation of health technology assessment: what is required for it to succeed?

Authors:  Michael Drummond; Rosanna Tarricone; Aleksandra Torbica
Journal:  Eur J Health Econ       Date:  2022-03-29

2.  Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective.

Authors:  Casey Quinn; Louis P Garrison; Anja K Pownell; Michael B Atkins; Gérard de Pouvourville; Kevin Harrington; Paolo Antonio Ascierto; Phil McEwan; Samuel Wagner; John Borrill; Elise Wu
Journal:  J Immunother Cancer       Date:  2020-07       Impact factor: 13.751

Review 3.  MRD in Venetoclax-Based Treatment for AML: Does it Really Matter?

Authors:  Massimo Bernardi; Felicetto Ferrara; Matteo Giovanni Carrabba; Sara Mastaglio; Francesca Lorentino; Luca Vago; Fabio Ciceri
Journal:  Front Oncol       Date:  2022-07-18       Impact factor: 5.738

4.  Impact of Managed Entry Agreements on availability of and timely access to medicines: an ex-post evaluation of agreements implemented for oncology therapies in four countries.

Authors:  Olina Efthymiadou; Panos Kanavos
Journal:  BMC Health Serv Res       Date:  2022-08-20       Impact factor: 2.908

5.  Development of a framework and decision tool for the evaluation of health technologies based on surrogate endpoint evidence.

Authors:  Oriana Ciani; Bogdan Grigore; Rod S Taylor
Journal:  Health Econ       Date:  2022-05-24       Impact factor: 2.395

Review 6.  Informed decision-making: Statistical methodology for surrogacy evaluation and its role in licensing and reimbursement assessments.

Authors:  Christopher J Weir; Rod S Taylor
Journal:  Pharm Stat       Date:  2022-07       Impact factor: 1.234
  6 in total

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