Participation in trials should be based on clinical uncertainty, not enforcement

EDITOR—The clinical relevance of new drugs in Alzheimer's disease has been much debated, and there is little dispute that we need improved trials in the disease.1 Enrolment into trials, however, should be governed by clinical uncertainty.2

Bentham et al criticise recently published studies of rivastigmine and advocate support for studies such as the AD2000 donepezil trial.3 We are concerned that some health authorities in the United Kingdom have stated that reimbursement for donepezil would be made only if patients were randomised into this trial. Presumably, following the lack of participation in the trial by many clinicians in the United Kingdom, the threat of non-reimbursement is an attempt to aid flagging recruitment.

Many clinicians have chosen not to be involved for good reasons. Part of the trial's complicated design seems to attempt to replicate the studies that formed the basis of regulatory approval. The manufacturers already have over 3000 patients with detailed controlled data over six months. The first three months of the trial, before rerandomisation, will not add to this assessment and may confuse rather than enlighten, especially given the use of only the …