Abstract
BackgroundLarge clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here a successful example of this type of collaboration in the field of dementia.MethodsThe Donepezil Data Repository comprised 18 randomised, controlled trials conducted between 1991 and 2005. The project team at Pfizer determined that the data mining process should be guided by a diverse group of leading Alzheimer's disease clinical researchers called the "Expert Working Group." After development of a list of potential faculty members, invitations were extended and a group of seven members was assembled. The Working Group met regularly with Eisai/Pfizer clinicians and statisticians to discuss the data, identify issues that were currently of interest in the academic and clinical communities that might lend themselves to investigation using these data, and note gaps in understanding or knowledge of Alzheimer's disease that these data could address. Leadership was provided by the Pfizer Clinical Development team leader; Working Group members rotated responsibility for being lead and co-lead for each investigation and resultant publication.ResultsSix manuscripts, each published in a leading subspecialty journal, resulted from the group's work. Another project resulted in poster presentations at international congresses and two were cancelled due to resource constraints.ConclusionsThe experience represents a particular approach to optimising the value of data mining of large clinical trial databases for the combined purpose of furthering clinical research and improving patient care. Fruitful collaboration between industry and academia was fostered while the donepezil data repository was used to advance clinical and scientific knowledge. The Expert Working Group approach warrants consideration as a blueprint for conducting similar research ventures in the future.
Highlights
Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers
The main objectives of the project were to identify a set of clinical questions that could be addressed by data mining, to prioritise the potential projects and determine which ones to pursue and to carry out these projects with the intention of presenting the findings at major congresses and publishing them in leading peer-reviewed academic journals
Six published manuscripts resulted from the work of the EWG
Summary
Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. There are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. This article describes how one drug development team, in partnership with key therapy area experts, used their database of clinical trials of donepezil, a symptomatic treatment for patients with Alzheimer’s disease (AD), to address questions beyond the scope of the original studies. This collaboration, titled the “Donepezil Expert Working Group project,” resulted in numerous publications addressing important clinical and scientific questions concerning AD and its treatment
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