Auditing experiences in Spain and Portugal of a multinational, large scale Phase IV study

Abstract

This study was undertaken by a Spanish Sponsor (J. Uriach and Cia) who contracted with Country Consultancy an independent audit facility owned by the author, to oversee a percentage of sites in both Spain and Portugal involved in this randomized, double-blind, parallel, two-group, multi- centric, Phase IV study. The main aim of the study was to compare the efficacy of the test compound (Triflusal) with acetyl salicylic acid (ASA) in secondary prevention of cerebral infarction. As regards the most evaluable, but variable, the study's primary end-points were the combined incidence of cardiovascular death, recurrence of non-fatal cerebral infarction and non- fatal acute myocardial infarction (AMI). The study population numbers were recruited from those patients with a history of transient ischaemic attack (TIA) or cerebral infarction, within the previous 6 months, confirmed by a neurological evaluation and clinical course, with a demonstrated existence of neurological deficit at some point, which may or may not be present at the time of patient inclusion. Patients were able to participate in the study regardless of the number of previous episodes suffered, if their score in the Oxford scale was less than or equal to 2 at the time of inclusion. The period of time elapsed between symptoms onset and subject's inclusion into the study was at least 15 days. A total number of 2062 evaluable patients was needed, assuming an incidence of primary events of 18% in the ASA group and an absolute 5% reduction for this index in the Triflusal group (α = 0.05; β = 0.2) was 1940, that being 970 per treatment group. At the time the study closed out, 2113 patients had been recruited and were active, or had been active, in the study. As regards the treatment schedule, patients were randomly assigned to two groups, one having two capsules of the Triflusal (600 mg/day) and the other ASA (325 mg/day) at the same dosing regime. The estimated mean duration of the treatment was approximately 2 years, with each patient receiving the assigned treatment until the end of the trial. The minimum period of the trial for each patient was I year or until discontinuation when necessary due to the appearance of an adverse event or reaction. The overall experimental duration of the study was 3 years. The study started in January 1996 with a recruitment period of 2 years. The follow-up was finished in August 1999. Copyright (C) 1998 John Wiley and Sons, Ltd.