PMID: 9551282Apr 29, 1998Paper

Threats to the validity of clinical trials employing enrichment strategies for sample selection

Controlled Clinical Trials
P D Leber, C S Davis

Abstract

Subject selection and exclusion criteria employed in typical clinical effectiveness trials of investigational new drugs have two fundamental aims: (1) to ensure that patients entering a study are truly suffering from the condition the drug is intended to treat and (2) to maximize the likelihood that the study will detect an effect of the drug if, in fact, one exists. Typical protocol selection criteria not only specify exacting procedures for establishing and documenting the diagnosis of those recruited for a study but also seek to increase, relative to the prevalence in the general population, the proportion of individuals in the sample likely to respond to pharmacological treatment. Because it is ordinarily impossible to learn prior to extensive clinical experience with a new drug which, if any, patient characteristics reliably predict a consistent treatment response, strategies for sample "enrichment" typically operate by excluding patients (for example, those with very advanced and/or complicated illness, those with serious concomitant illness, those at the extremes of age, those with very mild illness, and so forth) in whom a dependable response to treatment seems unlikely on logical and/or generic grounds. Some studies us...Continue Reading

References

Oct 1, 1975·Journal of Clinical Pharmacology·W Amery, J Dony
Aug 1, 1991·Controlled Clinical Trials·A P HallstromL Friedman
Oct 1, 1990·Controlled Clinical Trials·E Brittain, J Wittes
Jan 1, 1990·Statistics in Medicine·J M Lang
Nov 13, 1986·The New England Journal of Medicine·W K SummersA Kling
Aug 1, 1967·Journal of Chronic Diseases·D Schwartz, J Lellouch
Mar 24, 1983·The New England Journal of Medicine
Nov 1, 1982·The American Journal of Psychiatry·K L Davis, R C Mohs
Sep 1, 1981·Journal of Clinical Psychopharmacology·F M Quitkin, J G Rabkin
Sep 1, 1993·Journal of Clinical Epidemiology·J A KopecJ M Esdaile

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Citations

Nov 19, 2004·European Archives of Psychiatry and Clinical Neuroscience·M RiedelH-J Möller
Jan 25, 2008·The Psychiatric Quarterly·Douglas L BoggsRobert R Conley
Sep 6, 2006·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·Coralia Bueno MuíñoEduardo Díaz-Rubio
Mar 12, 2002·Journal of Psychiatric Research·Richard Entsuah, Jack M Gorman
Mar 8, 2012·Brain : a Journal of Neurology·Wesley ThevathasanPeter Brown
Jul 24, 2001·Anesthesiology·C J Woolf, M B Max
Jun 19, 2002·Alzheimer Disease and Associated Disorders·Steven H Ferris
Mar 20, 2008·Current Opinion in Rheumatology·Joel M KremerJeffrey D Greenberg
Dec 22, 2010·Alzheimer's Research & Therapy·Joshua D Grill, Jason Karlawish
Jul 29, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Pingfu FuMark Schluchter
Sep 29, 2011·Clinical Chemistry and Laboratory Medicine : CCLM·Thomas I Peng SohFederico Innocenti
May 2, 2007·The Canadian Journal of Neurological Sciences. Le Journal Canadien Des Sciences Neurologiques·Chris MacKnight
Aug 10, 1999·Controlled Clinical Trials·V W Berger, D V Exner
Apr 12, 2003·Controlled Clinical Trials·Vance W BergerVanessa A Makarewicz
Jan 7, 2003·Hematology/oncology Clinics of North America·Brigette B Y MaLillian L Siu
May 27, 2008·The American Journal of Medicine·Jeffrey D GreenbergUNKNOWN Consortium of Rheumatology Researchers of North America Investigators
May 27, 2005·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·S M PatelA J Lembo
Jul 1, 2011·Biometrics·Mithat Gönen
Apr 21, 2001·The Journal of ECT·W V McCallC H Kellner
Mar 10, 2012·Contemporary Clinical Trials·Jarkko KalliomäkiRolf Karlsten
Sep 1, 2011·Clinical Trials : Journal of the Society for Clinical Trials·Tarek A HammadGeorge A Neyarapally
Feb 21, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Afshin Dowlati, Pingfu Fu
Jun 29, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Boris Freidlin, Richard Simon
Nov 15, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Gary L RosnerMark J Ratain
Jul 19, 2011·The Journal of Rheumatology·Jacob KarshUNKNOWN Canadian Rheumatology Research Consortium

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