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Titolo:
Patient notification and follow-up after suspension of treatment protocols: Experience from four clinical trials of treatments for AIDS-related CMV retinitis
Autore:
Holbrook, JT; Meinert, CL; Jabs, DA;
Indirizzi:
Johns Hopkins Univ, Sch Hyg & Publ Hlth, Ctr Clin Trials, Baltimore, MD USA Johns Hopkins Univ Baltimore MD USA , Ctr Clin Trials, Baltimore, MD USA Johns Hopkins Univ, Sch Med, Dept Ophthalmol, Baltimore, MD 21205 USA Johns Hopkins Univ Baltimore MD USA 21205 halmol, Baltimore, MD 21205 USA Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21205 USA Johns Hopkins Univ Baltimore MD USA 21205 pt Med, Baltimore, MD 21205 USA
Titolo Testata:
CONTROLLED CLINICAL TRIALS
fascicolo: 1, volume: 22, anno: 2001,
pagine: 62 - 68
SICI:
0197-2456(200102)22:1<62:PNAFAS>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Keywords:
patient notification; closeout procedures; clinical trial; protocol suspension;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
9
Recensione:
Indirizzi per estratti:
Indirizzo: Holbrook, JT SOCA Chairmans Off, 550 N Broadway,Suite 700, Baltimore, MD 21205 USA SOCA Chairmans Off 550 N Broadway,Suite 700 Baltimore MD USA 21205
Citazione:
J.T. Holbrook et al., "Patient notification and follow-up after suspension of treatment protocols: Experience from four clinical trials of treatments for AIDS-related CMV retinitis", CONTR CL TR, 22(1), 2001, pp. 62-68

Abstract

We reviewed procedures for and data about patient notification of the suspension of the treatment protocol for four clinical trials. We also examinedhow data collected after the suspensions were used. All four trials were designed to evaluate treatments for cytomegalovirus retinitis in patients with AIDS and were conducted by the Studies of Ocular Complications of AIDS Research Group. Documentation that patients were notified of the results varied from 62-100% with three of the four studies documenting the process forgreater than or equal to 92% of patients. The median time between the recommendation for protocol suspension and patient notification varied from 7-49 days with three of the four trials at 12 days or fewer. Most of the analyses of data collected after the suspension of the treatment protocol did not focus on comparisons among treatment groups. Although they provided useful information about the long-term outcomes and the nature of the disease, they did not alter the conclusions about safety and efficacy from the randomized portion of the trial. (C) Elsevier Science Inc. 2001.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/07/20 alle ore 23:52:14