AB020. To produce a white paper on: ‘how to develop the perfect real-time, real-world effectiveness and cost-effectiveness trial’

Background: The Salford Lung Study (SLS) involves two prospective patient cohorts—one patients with asthma; the other patients with COPD. SLS is believed to be the first pre-license, prospective randomised controlled trial (RCT) to use electronic healthcare records to monitor patient safety. Safety events are processed in near real-time, and a linked database system creates daily summaries that alert a specialist safety team to potential treatment-related adverse events. SLS is a ‘world first’ in effectiveness research. To synthesise the learnings from the SLS and experiences from leading experts in real-world research in a White Paper to help guide the future design and feasibility of pragmatic RCTs.

Methods: Hold an advisory board involving representatives from: the pioneering SLS collaboration (between the UK National Health Service, The University of Manchester, GlaxoSmithKline); the Pharmaceutical Industry, Government, regulatory and health technology appraisal agencies as well as clinical experts, social scientists and information technology specialists to pool expertise in effectiveness and cost-effectiveness research. Through shared experiences, discussion and consensus, develop a joint stakeholder position on the value of effectiveness and cost-effectiveness research and clear standards to guide the future design and delivery of meaningful, affordable and implementable pragmatic RCTs in the future.

Results: None available at the time of writing.

Conclusions: There have been significant advances in effectiveness and cost-effectiveness research in recent years and important learnings resulting from the SLS. Current expertise must be shared, documented and discussed by experts and used to develop standards to guide optimised use of research resource in the future.

Keywords: Salford Lung Study (SLS); randomised controlled trial (RCT); effectiveness and cost-effectiveness research