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Meta-analysis of clinical trial data informing a NICE submission

Client need

Our client wanted to assess the heterogeneity of outcomes across a range of relevant clinical trials to demonstrate the consistency of effect of their product in the context of a NICE submission.

Our response

The Initiate team conducted a comprehensive update of an existing clinical SLR to identify all relevant studies. These studies were then combined in a meta-analysis which demonstrated consistency across the available evidence. We also conducted meta-analysis of subgroup data to show that benefits were consistent in trial populations more generalisable to an NHS setting.

Client value

The meta-analysis formed an integral part of the submission and helped support the argument that all available clinical evidence pointed in the same direction for our clients’ product, thus strengthening the argument for reimbursement in the context of trial heterogeneity.

Quote

“It was amazing and so refreshing to work with you, and I remain very grateful for the way you went over and above the project requirements. Not only do you understand the company objectives, but your expertise on this project resulted in very strong evidence generation objectives and a great start to the product’s value demonstration journey.”

Market Access Consultant, BioPharma