PMID: 9438743Jan 23, 1998Paper

Run-in periods in randomized trials: implications for the application of results in clinical practice

JAMA : the Journal of the American Medical Association
A Pablos-MéndezS Shea

Abstract

Prerandomization run-in periods are being used to select or exclude patients in an increasing number of clinical trials, but the implications of run-in periods for interpreting the results of clinical trials and applying these results in clinical practice have not been systematically examined. We analyzed illustrative examples of reports of clinical trials in which run-in periods were used to exclude noncompliant subjects, placebo responders, or subjects who could not tolerate or did not respond to active drug. The Physicians' Health Study exemplifies the use of a prerandomization run-in period to exclude subjects who are nonadherent, while recent trials of tacrine for Alzheimer disease and carvedilol for congestive heart failure typify the use of run-in periods to exclude patients who do not tolerate or do not respond to the study drug. The reported results of these studies are valid. However, because the reported results apply to subgroups of patients who cannot be defined readily based on demographic or clinical characteristics, the applicability of the results in clinical practice is diluted. Compared with results that would have been observed without the run-in period, the reported results overestimate the benefits and und...Continue Reading

Citations

Jul 22, 2010·Nutrition Reviews·Suhad S AbuMweisPeter J H Jones
Feb 27, 2008·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Kiranbir JosanFinlay A McAlister
Jun 24, 2008·Brain : a Journal of Neurology·Barry S Oken
Mar 20, 2009·Annual Review of Public Health·C Hendricks BrownRobert D Gibbons
Apr 21, 2009·International Journal of Epidemiology·O M DekkersJ P Vandenbroucke
Jan 5, 2002·Journal of Clinical Psychopharmacology·D E FariesW Z Potter
Jan 1, 2008·Journal of Clinical and Experimental Neuropsychology·Barry S OkenDawn Peters
Sep 24, 1999·American Journal of Physical Medicine & Rehabilitation·D G TateR B Karunas
May 15, 2001·Optometry and Vision Science : Official Publication of the American Academy of Optometry·J J WallineK Zadnik
Nov 22, 2011·Expert Review of Pharmacoeconomics & Outcomes Research·Afschin Gandjour
Sep 18, 2015·International Journal of Epidemiology·John O YoungeM G Myriam Hunink
Apr 4, 2016·Trends in Cardiovascular Medicine·Jonathan S Gordin, Gregg C Fonarow
Dec 18, 2003·British Journal of Clinical Pharmacology·Karin MartinNicholas Moore
Feb 2, 2013·Journal of Evaluation in Clinical Practice·Jonathan Fuller
Oct 15, 2013·Obesity Reviews : an Official Journal of the International Association for the Study of Obesity·O AffusoD B Allison
May 13, 2010·Journal of Public Health Dentistry·James D BaderUNKNOWN X-ACT Collaborative Research Group
Dec 21, 2004·Drug and Alcohol Dependence·Adam BisagaEdward V Nunes
Jan 24, 2006·Contemporary Clinical Trials·Lisa A ConboyCatherine E Kerr
Aug 19, 2015·Mayo Clinic Proceedings·Vinay Prasad, Vance W Berger
Nov 26, 2010·Journal of Prosthodontic Research·Glenn T Clark, Roseann Mulligan
Jun 21, 2008·Contemporary Clinical Trials·Michelle UlmerSundar Natarajan
Nov 1, 2007·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Dyfrig HughesUNKNOWN International Society for Pharmacoeconomics & Outcomes Research Economics of Medication Compliance Working Group
Jul 31, 2016·Trials·Judy R ReesJanet L Peacock
Oct 8, 2013·Journal of the National Cancer Institute·Fangxin Hong, Richard Simon
May 29, 2015·Angiology·Thomas F Whayne
Feb 17, 2018·Journal of General Internal Medicine·Michael FralickAaron S Kesselheim
Feb 3, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Ingunn F TveteLars Holden
May 19, 2011·Nature Reviews. Genetics·Isaac S Kohane
Mar 10, 2018·Journal of General Internal Medicine·Michael FralickAaron S Kesselheim
Jun 8, 2007·Clinical Pharmacology and Therapeutics·S Schneeweiss
Jun 24, 2017·The European Respiratory Journal·Samy Suissa
Jan 16, 2015·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Qiang XiaLucia V Torian
Nov 16, 2019·Pharmacoepidemiology and Drug Safety·Tessa A HulshofHendrika J Luijendijk

❮ Previous
Next ❯

Related Concepts

Related Feeds

Atrial Fibrillation

Atrial fibrillation is a common arrhythmia that is associated with substantial morbidity and mortality, particularly due to stroke and thromboembolism. Here is the latest research.

Arrhythmia

Arrhythmias are abnormalities in heart rhythms, which can be either too fast or too slow. They can result from abnormalities of the initiation of an impulse or impulse conduction or a combination of both. Here is the latest research on arrhythmias.

Related Papers

Critical Care : the Official Journal of the Critical Care Forum
Pinaki DuttaRajesh Rajput
Journal of Clinical Epidemiology
P KnipschildA R Feinstein
BMJ : British Medical Journal
S Senn
Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology
M H Trivedi, H Rush
© 2021 Meta ULC. All rights reserved