Organisation of a clinical trial unit--a proposal

The urgent need for the performance of more, better designed, and better conducted randomised clinical trials is increasingly recognised. Based on structured interviews with leading persons of 43 outstanding organisations and units involved in clinical trials in Europe and North America during 1993, ways of organising and staffing clinical trial units were investigated. The present proposal is based on this experience from which an attempt to extract a composite set of minimal requirements has been made regarding pertinent objectives and aims, organisational aspects, staffing, and estimated costs of establishing a clinical trial unit. The core staff is suggested to consist of two chief physicians, one statistician, one data manager, one project coordinator, and two secretaries. In order to fulfil the minimal requirements for running such a unit, it is calculated that about GBP 450,000 per year is needed to cover investments, core staff, and running costs, but excluding housing costs and costs of randomised clinical trials that do not originate from trial coordination. In return, such a unit should be able to mount and launch 6-7 multicenter randomised clinical trials during a 5 year period, corresponding to a total cost for coordination per trial of about GBP 340,000. However, with a larger staff more studies may be coordinated possibly reducing the cost per trial depending on greater effectiveness in utilisation of the basic facilities.