Abstract
Comparative effectiveness research (CER) is still an evolving framework for which much needs to be done to improve the ability of randomized controlled trials (RCTs) to supply the necessary evidence. Perhaps, most important is to start with a clearly specified decision and decision maker in mind when the RCTs are designed. Second is to initiate RCTs with clinically relevant outcomes and comparators earlier in the evaluation process. Third is to specify and measure factors that might modify the intervention's effect, subject to logistical constraints of complexity and cost, so the trial is maximally informative, about how and to whom the intervention should be administered. It will be necessary to borrow observational methodologies and approaches to extract meaningful causal and subgroup inferences from such trials. Process variables should be seen as potentially part of that framework of effect-modifying factors, perhaps amenable to embedded experimental assessment with a trial. Perhaps most importantly, we need to improve the nationwide CER infrastructure to allow for rapid initiation and accrual for CER trials to reduce the trade-off that often exists between the speed of evidence development and its quality.
References
Nov 7, 1985·The New England Journal of Medicine·UNKNOWN EC/IC Bypass Study Group
Mar 26, 1987·The New England Journal of Medicine·S GoldringT Langfitt
Dec 16, 1998·Annals of Internal Medicine·D M Berwick
Jun 18, 2002·Spine·Nancy J O BirkmeyerJohn E Wennberg
Sep 25, 2003·JAMA : the Journal of the American Medical Association·Sean R TunisCarolyn M Clancy
Sep 30, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David M Dilts, Alan B Sandler
Sep 30, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David M DiltsUNKNOWN Case of Cancer and Leukemia Group B
Jun 1, 2007·The New England Journal of Medicine·James N WeinsteinSerena S Hu
Sep 26, 2007·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Max H PittlerEdzard Ernst
Jun 4, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·David M DiltsRobert Comis
Mar 4, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David M DiltsJeffrey Abrams
Apr 8, 2009·Journal of Clinical Epidemiology·Kevin E ThorpeKalipso Chalkidou
Jul 2, 2009·Annals of Internal Medicine·Bryan R LuceJ Sanford Schwartz
Aug 12, 2009·Journal of Pain & Palliative Care Pharmacotherapy·UNKNOWN National Institute of Neurological Disorders, National Institutes of Health
Apr 24, 2010·The New England Journal of Medicine·John A Jarcho
Apr 24, 2010·The New England Journal of Medicine·Michael X PhamUNKNOWN IMAGE Study Group
Aug 5, 2010·Journal of the National Cancer Institute·John F Scoggins, Scott D Ramsey
Nov 11, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·David M DiltsJames H Doroshow
May 18, 2011·Annals of Internal Medicine·Tyler J VanderWeele, Mirjam J Knol
Nov 10, 2011·JAMA : the Journal of the American Medical Association·William J PowersUNKNOWN COSS Investigators
Citations
Nov 6, 2012·Clinical Psychology Review·Maria M Steenkamp, Brett T Litz
Apr 16, 2013·The Journal of Urology·Michael J BelsanteAllen F Morey
Oct 17, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Edward L Korn, Boris Freidlin
May 24, 2013·The Oncologist·Gary H Lyman
Feb 2, 2021·Pain Reports·Robert H DworkinChristin Veasley