The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Clinical center recruitment experience

Jackson T. Wright, William Cushman, Barry R. Davis, Joshua Barzilay, Pedro Colon, Debra Egan, Tracy Lucente, Chuke Nwachuku, Sara Pressel, Frans H.H. Leenen, Joseph Frolkis, Rebecca Letterer, Sandra Walsh, Jonathan N. Tobin, Grant E. Deger

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized clinical outcome trial of antihypertensive and lipid-lowering therapy in a diverse population (including substantial numbers of women and minorities) of 42,419 high-risk hypertensives aged ≥ 55 years with a planned mean follow-up of 6 years. In this paper, we describe our experience in the identification, recruitment, and selection of clinical centers for this large simple trial capable of meeting the recruitment goals outlined for ALLHAT, and we highlight factors associated with clinical center performance. Over 135,000 recruitment brochures were mailed to physicians. Requests for information and application packets were received from 9351 (6.8%) interested investigators. A total of 1053 completed applications were received and 909 sites (86%) were eventually approved to join the trial. Of the approved sites, 278 either later declined participation or were never activated, and 8 were closed within a year for lack of enrollment. The final 623 randomizing centers exceeded the trial's recruitment goal to enroll at least 40,000 participants into the trial, although the recruitment period was extended 1.5 years longer than planned. Fewer than a quarter of the sites (22.6%) were recruited from academic medical centers or Department of Veterans Affairs Medical Centers. More than half of the sites (54.7%) were private solo or group practices, which contributed 53% of randomized participants. Community health centers comprised about 8% of the ALLHAT sites and 2.9% were part of health maintenance organizations. More than 22% of the principal investigators reported that they had no previous clinical research experience. In summary, ALLHAT was successful in recruiting a diverse group of clinical centers to achieve its patient recruitment goals.

Original languageEnglish (US)
Pages (from-to)659-673
Number of pages15
JournalControlled Clinical Trials
Volume22
Issue number6
DOIs
StatePublished - Dec 31 2001
Externally publishedYes

Fingerprint

Antihypertensive Agents
Myocardial Infarction
Clinical Trials
Lipids
Private Practice
Research Personnel
Therapeutics
Community Health Centers
Group Practice
Pamphlets
Health Maintenance Organizations
Veterans
Patient Selection
Randomized Controlled Trials
Physicians
Research
Population

All Science Journal Classification (ASJC) codes

  • Pharmacology

Cite this

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) : Clinical center recruitment experience. / Wright, Jackson T.; Cushman, William; Davis, Barry R.; Barzilay, Joshua; Colon, Pedro; Egan, Debra; Lucente, Tracy; Nwachuku, Chuke; Pressel, Sara; Leenen, Frans H.H.; Frolkis, Joseph; Letterer, Rebecca; Walsh, Sandra; Tobin, Jonathan N.; Deger, Grant E.

In: Controlled Clinical Trials, Vol. 22, No. 6, 31.12.2001, p. 659-673.

Research output: Contribution to journalArticle

Wright, JT, Cushman, W, Davis, BR, Barzilay, J, Colon, P, Egan, D, Lucente, T, Nwachuku, C, Pressel, S, Leenen, FHH, Frolkis, J, Letterer, R, Walsh, S, Tobin, JN & Deger, GE 2001, 'The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT): Clinical center recruitment experience', Controlled Clinical Trials, vol. 22, no. 6, pp. 659-673. https://doi.org/10.1016/S0197-2456(01)00176-3
Wright, Jackson T. ; Cushman, William ; Davis, Barry R. ; Barzilay, Joshua ; Colon, Pedro ; Egan, Debra ; Lucente, Tracy ; Nwachuku, Chuke ; Pressel, Sara ; Leenen, Frans H.H. ; Frolkis, Joseph ; Letterer, Rebecca ; Walsh, Sandra ; Tobin, Jonathan N. ; Deger, Grant E. / The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) : Clinical center recruitment experience. In: Controlled Clinical Trials. 2001 ; Vol. 22, No. 6. pp. 659-673.
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AU - Nwachuku, Chuke

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