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 completio n 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 Tri al are described. (C) Elsevier Science Inc. 2001.