PMID: 8446807Jan 30, 1993Paper

A comprehensive algorithm for determining whether a run-in strategy will be a cost-effective design modification in a randomized clinical trial

Statistics in Medicine
K B Schechtman, M E Gordon

Abstract

In randomized clinical trials, poor compliance and treatment intolerance lead to reduced between-group differences, increased sample size requirements, and increased cost. A run-in strategy is intended to reduce these problems. In this paper, we develop a comprehensive set of measures specifically sensitive to the effect of a run-in on cost and sample size requirements, both before and after randomization. Using these measures, we describe a step-by-step algorithm through which one can estimate the cost-effectiveness of a potential run-in. Because the cost-effectiveness of a run-in is partly mediated by its effect on sample size, we begin by discussing the likely impact of a planned run-in on the required number of randomized, eligible, and screened subjects. Run-in strategies are most likely to be cost-effective when: (1) per patient costs during the post-randomization as compared to the screening period are high; (2) poor compliance is associated with a substantial reduction in response to treatment; (3) the number of screened patients needed to identify a single eligible patient is small; (4) the run-in is inexpensive; (5) for most patients, the run-in compliance status is maintained following randomization and, most importa...Continue Reading

References

Nov 1, 1976·Psychological Medicine·P LeyC E Skilbeck
Oct 1, 1991·Statistics in Medicine·J M LangC H Hennekens
Aug 1, 1991·The New England Journal of Medicine·UNKNOWN SOLVD InvestigatorsJay N Cohn
Jun 1, 1990·Controlled Clinical Trials·L S Freedman
Jun 1, 1990·Controlled Clinical Trials·W C BlackwelderM A Deloria
Oct 1, 1990·Controlled Clinical Trials·E Brittain, J Wittes
Jan 1, 1990·Statistics in Medicine·J M Lang
Aug 10, 1989·The New England Journal of Medicine·UNKNOWN Cardiac Arrhythmia Suppression Trial (CAST) Investigators
Jul 20, 1989·The New England Journal of Medicine·UNKNOWN Steering Committee of the Physicians' Health Study Research Group
Jun 9, 1989·JAMA : the Journal of the American Medical Association·J A CramerV L Ouellette
May 15, 1986·American Journal of Ophthalmology·M A KassJ Goldberg
May 15, 1986·American Journal of Ophthalmology·M A KassD W Meltzer
Jul 1, 1972·Clinical Pharmacology and Therapeutics·R B Stewart, L E Cluff
Feb 15, 1980·JAMA : the Journal of the American Medical Association

❮ Previous
Next ❯

Citations

Feb 1, 1995·Controlled Clinical Trials·C E DavisM McCormick
Apr 12, 2003·Controlled Clinical Trials·Vance W BergerVanessa A Makarewicz
Nov 16, 2019·Pharmacoepidemiology and Drug Safety·Tessa A HulshofHendrika J Luijendijk
Jul 2, 2014·Clinical Trials : Journal of the Society for Clinical Trials·Lynn HuynhMilo A Puhan
Oct 2, 2020·Journal of Clinical Epidemiology·David CollisterMichael Walsh
Jun 8, 2021·Contemporary Clinical Trials·David CollisterUNKNOWN ACHIEVE investigators

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.