Biometrics. 1987 Mar;43(1):213-23.

Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners.

Abstract

Recent developments in group sequential methods have had a great impact on the design and analysis of randomized clinical trials. The consequences for both planned and unplanned interim analyses are discussed using several real trials as illustrations. Guidelines for the conduct of interim analysis are given, including tables of nominal significance levels and required sample sizes for several group sequential plans. Areas in need of further theoretical advance include multiple endpoints, estimation of treatment differences, stratification, and design of multiple-armed trials.

PMID:: 3567306; [PubMed - indexed for MEDLINE]

Publication Types, MeSH Terms

Publication Types

Research Support, Non-U.S. Gov't

MeSH Terms

LinkOut - more resources

Education

New England Research Institutes Inc.

Medical

Supplemental Content

Save items

Related citations in PubMed

Planned interim analysis and its role in cancer clinical trials. [J Clin Oncol. 1987]
Planned interim analysis and its role in cancer clinical trials.
Geller NL. J Clin Oncol. 1987 Sep; 5(9):1485-90.
Review General statistical design considerations of randomized clinical trials. [Prog Clin Biol Res. 1988]
Review General statistical design considerations of randomized clinical trials.
Peduzzi P. Prog Clin Biol Res. 1988; 264:61-70.
Review Complexity and contradiction in clinical trial research. [Am J Med. 1987]
Review Complexity and contradiction in clinical trial research.
Horwitz RI. Am J Med. 1987 Mar; 82(3):498-510.
[Termination rules in therapeutic trials. Application of sequential methods in 2 clinical trials in hematology]. [Nouv Rev Fr Hematol. 1987]
[Termination rules in therapeutic trials. Application of sequential methods in 2 clinical trials in hematology].
Bénichou J, Lepage E, Chastang C. Nouv Rev Fr Hematol. 1987; 29(1):87-91.
Review A group sequential, response-adaptive design for randomized clinical trials. [Control Clin Trials. 2003]
Review A group sequential, response-adaptive design for randomized clinical trials.
Karrison TG, Huo D, Chappell R. Control Clin Trials. 2003 Oct; 24(5):506-22.

See reviews... See all...

Cited by 10 PubMed Central articles

Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders. [BMC Musculoskelet Disord. 2011]
Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders.
Hahne AJ, Ford JJ, Surkitt LD, Richards MC, Chan AY, Thompson SL, Hinman RS, Taylor NF. BMC Musculoskelet Disord. 2011 May 20; 12:104. Epub 2011 May 20.
Review Pressure and volume limited ventilation for the ventilatory management of patients with acute lung injury: a systematic review and meta-analysis. [PLoS One. 2011]
Review Pressure and volume limited ventilation for the ventilatory management of patients with acute lung injury: a systematic review and meta-analysis.
Burns KE, Adhikari NK, Slutsky AS, Guyatt GH, Villar J, Zhang H, Zhou Q, Cook DJ, Stewart TE, Meade MO. PLoS One. 2011 Jan 28; 6(1):e14623. Epub 2011 Jan 28.
Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice. [Trials. 2010]
Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice.
Rischio and Prevenzione Investigators. Trials. 2010 May 28; 11:68. Epub 2010 May 28.

See all...

Related information

Related Citations
Calculated set of PubMed citations closely related to the selected article(s) retrieved using a word weight algorithm. Related articles are displayed in ranked order from most to least relevant, with the “linked from” citation displayed first.
Cited in PMC
Full-text articles in the PubMed Central Database that cite the current articles.

Recent activity

Clear Turn Off Turn On

Interim analyses in randomized clinical trials: ramifications and guidelines for...
Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners.
Biometrics. 1987 Mar ;43(1):213-23.

PubMed
Rapid diagnosis of meningitis with use of selected clinical data and gas-liquid ...
Rapid diagnosis of meningitis with use of selected clinical data and gas-liquid chromatographic determination of lactate concentration in cerebrospinal fluid.
J Infect Dis. 1979 May ;139(5):529-33.

PubMed
An assessment of clinically useful measures of the consequences of treatment.
An assessment of clinically useful measures of the consequences of treatment.
N Engl J Med. 1988 Jun 30 ;318(26):1728-33.

PubMed
[Biological properties of meningococci isolated from the carriers].
[Biological properties of meningococci isolated from the carriers].
Zdravookhr Kirg. 1975 Mar-Apr ;(2):39-42.

PubMed
Meta-analysis of clinical trials as a scientific discipline. I: Control of bias ...
Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials.
Stat Med. 1987 Apr-May ;6(3):315-28.

PubMed

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

PubMed

Result Filters

Display Settings:

Send to: