Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom.

The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom.

Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial.

Background: The UK Clinical Trial Regulations and Good Clinical Practice guidelines specify that the study sponsor must ensure clinical trial data are accurately reported, recorded and verified to ensure patient safety and scientific integrity. The methods that are utilised to assess data quality and the results of any reviews undertaken are rarely reported in the literature. We have recently undertaken a quality review of trial data submitted to a Clinical Endpoint Committee for adjudication.

Closing out a large clinical trial: lessons from the prospective study of pravastatin in the elderly at risk (PROSPER).

Relatively little has been written about the practicalities of the closeout of large, multi-centre clinical trials, but this aspect of trial conduct and design is both important and requires careful planning in order to be accomplished in a timely and orderly fashion. Here, we document our recent experiences of closing down the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). This five-year study with over 5800 subjects was closed down and published in 2002.

Unblinding of trial participants to their treatment allocation: lessons from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER).

Background: The gold standard clinical trial design is the double-blind, randomized, controlled trial. No standard practice exists for the "unblinding" of trial participants and no legal obligation is placed on investigators to inform participants of their treatment allocation or study results at the end of a trial. Here we document our experiences of unblinding the 2520 Scottish participants in the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER).