The closeout process for a clinical trial terminated early for lagging enrollment and inadequate follow-up.
Closeout of a clinical trial, whether carried out to its original completion of full accrual and attendant follow-up or stopped prematurely because of early indications of efficacy or adverse toxicity, presents challenges in many areas. Closing a clinical trial that fails to adequately accrue and/or successfully follow up patients may exacerbate these problems. The issues involved in the early termination of the Low-Dose Oral Alpha Interferon Trial are described. Control Clin Trials 2001;22:49-55
Muth
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K
WESTAT, Rockville, MD 28050, USA. ellenbj2@westat.com
Yu
E
E
Alston
B
B
Ellenberg
J H
JH
D000284:Administration, Oral; D000328:Adult; D018791:CD4 Lymphocyte Count; D003625:Data Collection / Q000706:statistics & numerical data*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data*; D018579:Patient Selection; D015996:Survival Rate; D017211:Treatment Failure
D016898:Interferon-alpha