Our client had prepared a protocol to carry out a clinical study of a device with a view to obtaining a CE mark. They anticipated the need to gather information to support the case for reimbursement of the product, and asked Translucency to advise on how the current study design should be adapted, at minimum additional cost.
Translucency carried out a rapid review of the travailler avec des preuves for the product and carried out structured but relatively informal interviews with clinicians in its networks, and clinicians identified by the client. This included identifying current treatment alternatives for these patients. By bringing together this information with its existing knowledge of how key opinion leaders and key decision makers would assess the case for this product, Translucency identified the questions which the client should ideally be able to answer by reference to travailler avec des preuves when the product was launched. Relevant data items were listed: Translucency assessed the costs of collecting each data item, any possible ways of answering the question, and the drawback of not having the information.
Translucency combined its assessment for the list of data items so that the client could make fully informed choices about which items were to be added to the proposed study, which were to be collected in parallel with the proposed study, and which were not to be collected. Translucency used its methodological expertise to devise adaptations to the design of the proposed study which would reduce the costs and difficulties of obtaining key travailler avec des preuves.
The client accepted Translucency’s recommendations and adapted its study protocol accordingly. The client also instituted other measures to gather the required data. It is anticipated that the client will be well prepared to launch the product immediately after the device has been CE marked. Additional costs were small (approximately 15% of the budget originally set aside for a study to support a CE mark application) and should be recovered if access to the market is achieved as little as 2-3 months earlier than would otherwise have been the case.