It has been estimated that 85% of the millions of dollars spent on clinical research fails to be useful; however, there is an increasing mandate for clinical data to help inform meaningful, pragmatic approaches to disease management. The costs associated with conducting clinical trials to generate new insights is often too high when compared to the slim returns, especially in terms of quality of the clinical data collected. Yet maximizing the quality and variety of clinical data collection is a medical necessity, and a desirable business objective.

In general, the medical device industry spends hundreds of millions on Investigator Initiated Studies (IIS) or External Research Programs (ERP) each year, but there is limited quality control, monitoring and/or reuse of data generated in these studies.

To help resolve these challenges we propose a solution in which data generated through IIS will be of higher quality and should satisfy regulatory requirements for medical research such as those outlined in GCP and the MDR. Furthermore, our solution can maximize the impact of these IIS data for the investigator through successful scientific publications, and the sponsor through real-time progress reports and reuse of anonymous study data.

This white paper describes an approach that would enable medical device manufacturers to leverage anonymous data from IIS projects to support the fulfilment of PMCF data requirements.

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