The trials of clinical trials

Guy M. Mckhann

Research output: Contribution to journalArticle

Abstract

Controlled clinical trials are becoming increasingly frequent in neurology. A review of the literature indicates that several trials have serious flaws in study design and conduct that render the results questionable or uninterpretable. These reports, together with my own experience with the trial of plasmapheresis in the treatment of acute Guillain-Barré syndrome, have led me to conclude that while the formulation of the crucial research question and the definition of outcomes as a measure of efficacy are extremely important, the availability of a compliant patient population of appropriate size and the compliance by the study physicians are essential. Moreover, close cooperation with the statistician in planning the trial and the statistical strategy for analysis is also critical. Suggestions are made to aid the clinician in setting up the most efficacious trial and reporting the results.

Original languageEnglish (US)
Pages (from-to)611-614
Number of pages4
JournalArchives of Neurology
Volume46
Issue number6
DOIs
StatePublished - 1989

Fingerprint

Plasmapheresis
Controlled Clinical Trials
Neurology
Population Density
Compliance
Clinical Trials
Physicians
Research
Therapeutics

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Clinical Neurology
  • Neuroscience(all)

Cite this

The trials of clinical trials. / Mckhann, Guy M.

In: Archives of Neurology, Vol. 46, No. 6, 1989, p. 611-614.

Research output: Contribution to journalArticle

Mckhann, Guy M. / The trials of clinical trials. In: Archives of Neurology. 1989 ; Vol. 46, No. 6. pp. 611-614.
@article{7ae78ee993bc469b862ab1acbd8bb06d,
title = "The trials of clinical trials",
abstract = "Controlled clinical trials are becoming increasingly frequent in neurology. A review of the literature indicates that several trials have serious flaws in study design and conduct that render the results questionable or uninterpretable. These reports, together with my own experience with the trial of plasmapheresis in the treatment of acute Guillain-Barr{\'e} syndrome, have led me to conclude that while the formulation of the crucial research question and the definition of outcomes as a measure of efficacy are extremely important, the availability of a compliant patient population of appropriate size and the compliance by the study physicians are essential. Moreover, close cooperation with the statistician in planning the trial and the statistical strategy for analysis is also critical. Suggestions are made to aid the clinician in setting up the most efficacious trial and reporting the results.",
author = "Mckhann, {Guy M.}",
year = "1989",
doi = "10.1001/archneur.1989.00520420029020",
language = "English (US)",
volume = "46",
pages = "611--614",
journal = "Archives of Neurology",
issn = "0003-9942",
publisher = "American Medical Association",
number = "6",

}

TY - JOUR

T1 - The trials of clinical trials

AU - Mckhann, Guy M.

PY - 1989

Y1 - 1989

N2 - Controlled clinical trials are becoming increasingly frequent in neurology. A review of the literature indicates that several trials have serious flaws in study design and conduct that render the results questionable or uninterpretable. These reports, together with my own experience with the trial of plasmapheresis in the treatment of acute Guillain-Barré syndrome, have led me to conclude that while the formulation of the crucial research question and the definition of outcomes as a measure of efficacy are extremely important, the availability of a compliant patient population of appropriate size and the compliance by the study physicians are essential. Moreover, close cooperation with the statistician in planning the trial and the statistical strategy for analysis is also critical. Suggestions are made to aid the clinician in setting up the most efficacious trial and reporting the results.

AB - Controlled clinical trials are becoming increasingly frequent in neurology. A review of the literature indicates that several trials have serious flaws in study design and conduct that render the results questionable or uninterpretable. These reports, together with my own experience with the trial of plasmapheresis in the treatment of acute Guillain-Barré syndrome, have led me to conclude that while the formulation of the crucial research question and the definition of outcomes as a measure of efficacy are extremely important, the availability of a compliant patient population of appropriate size and the compliance by the study physicians are essential. Moreover, close cooperation with the statistician in planning the trial and the statistical strategy for analysis is also critical. Suggestions are made to aid the clinician in setting up the most efficacious trial and reporting the results.

UR - http://www.scopus.com/inward/record.url?scp=0024372277&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0024372277&partnerID=8YFLogxK

U2 - 10.1001/archneur.1989.00520420029020

DO - 10.1001/archneur.1989.00520420029020

M3 - Article

C2 - 2730374

AN - SCOPUS:0024372277

VL - 46

SP - 611

EP - 614

JO - Archives of Neurology

JF - Archives of Neurology

SN - 0003-9942

IS - 6

ER -