Endpoints for assessing drug activity in clinical trials

The Oncologist
Richard Pazdur

Abstract

Overall survival remains the gold standard for the demonstration of clinical benefit. An improvement in overall survival is a direct clinical benefit to patients. An analysis of overall survival requires larger patient numbers and longer follow-up than other endpoints. Survival analysis may be confounded by subsequent therapies. Time to progression usually requires smaller clinical trials and may be more rapidly assessed than trials using overall survival as an endpoint. This endpoint is not confounded by subsequent therapies. Time to progression must use the same evaluation techniques and schedules for all therapies being evaluated. Blinding of trials or the use of an external blinded radiographic review committee is recommended in assessing time to progression. Unlike overall survival and time to progression, which must be evaluated in randomized trials, response rates can be accurately assessed using a single-arm trial. Stable disease is not included in a response rate determination and is optimally evaluated by assessing tumor progression in a randomized trial. Improvement in disease-related symptoms is considered clinical benefit and may be an appropriate endpoint for drug approval.

References

Mar 29, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·John R JohnsonRichard Pazdur
Jan 14, 2005·Health Affairs·Thomas R Fleming

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Citations

Jan 11, 2012·European Journal of Clinical Pharmacology·Shoude ZhangBeibei Yang
Apr 10, 2013·Current Oncology Reports·Sausan Abouharb, Paul G Corn
Sep 18, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·N MethyF Bonnetain
Jan 11, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F E Vera-BadilloI F Tannock
Jun 5, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·G DanieleM Pirisi
Dec 7, 2010·Journal of the National Cancer Institute·Alberto Ocana, Ian F Tannock
Mar 26, 2010·American Journal of Therapeutics·Stella Augustus
Jul 31, 2012·The Oncologist·Sangeetha ReddyVirginia Kaklamani
Nov 16, 2013·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Shen KerenYang Beibei
Jun 14, 2014·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·C Camps-HerreroE Díaz-Rubio
Oct 15, 2014·Neuro-oncology·David A ReardonBenjamin M Ellingson
Sep 1, 2014·Current Treatment Options in Oncology·Terri S Armstrong, Mark R Gilbert
Mar 31, 2015·Expert Review of Anticancer Therapy·Catherine Rioufol, Gilles Salles
Oct 27, 2012·Expert Review of Anticancer Therapy·Bartosz ChmielowskiWilliam D Tap
Nov 5, 2011·Expert Review of Anticancer Therapy·Enrico FranceschiAlba A Brandes
May 24, 2012·Expert Opinion on Investigational Drugs·William J Gradishar
Oct 28, 2009·Expert Opinion on Biological Therapy·Norma Lynn FoxGilles Gallant
Aug 30, 2013·Expert Opinion on Drug Metabolism & Toxicology·Timothy A Yap, Sanjay Popat
Jun 22, 2012·Expert Opinion on Drug Discovery·Jessie M Wu, Carolyn A Staton
Feb 7, 2016·Journal of Vascular and Interventional Radiology : JVIR·Ron C GabaUNKNOWN Society of Interventional Radiology Technology Assessment Committee
Jul 3, 2013·Journal of Vascular and Interventional Radiology : JVIR·Ryan HickeyRiad Salem
Oct 23, 2012·The Ocular Surface·Gary D Novack
Jun 13, 2012·Gynecologic Oncology·Hyun Jong ParkYoung Tae Kim
Mar 1, 2012·Cancer Treatment Reviews·John R MackeyKathleen I Pritchard
May 7, 2011·The Ocular Surface·Gary D Novack
Oct 18, 2015·Neoplasia : an International Journal for Oncology Research·Bryan OronskyPeter Langecker
Nov 2, 2014·Annals of Oncology : Official Journal of the European Society for Medical Oncology·H Maeda, T Kurokawa
Jul 16, 2010·Journal of Cellular and Molecular Medicine·Ian M BuchananKevin Camphausen
Jan 21, 2014·Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus·B G MainJ M Blazeby
Oct 9, 2015·BioMed Research International·Junsheng MaFrancesco C Stingo

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