Implementing a unified data platform for medical device trials can yield significant improvements in efficiency, transparency, and standardization, providing resource- and budget-strapped trial teams with accessible, more accurate data for faster, more informed decisions.
The era of big data has led to an influx of vast amounts of information coming from disparate sources, causing challenges in its collection, storage and analysis in clinical trials, especially for medical devices.
In addition to demonstrating efficacy and safety, medical device clinical teams have the immense challenge of incorporating post-market considerations and new technologies and tools into their trial designs to establish differentiation in the market. Furthermore, compared to their pharmaceutical counterparts, these teams are often required to do so with limited budgets and resources.
While the size and complexity of medical device clinical trials may yield smaller volumes of data than drug trials, extended study durations and the multitude of data sources results in the need for efficiency, transparency, and standardization in device trials. This begs us to further explore the question, “What more can be done?”
By adopting a unified solution for data collection, medical device clinical teams can address these needs.
The Need for Efficiency
The lack of interoperability between different data sources and types – including different imaging modalities and formats, various eCOA/ePRO instruments, and wearable devices, such as Fitbits – can lead to costly trials with inefficiencies and missing data. Adopting a truly unified software solution for all data collection can bring greater efficiency to medical device clinical trials by reducing (and even eliminating) reconciliation efforts, as well as eliminating the need for costly and timely integration between multiple systems. Unifying the systems used for study conduct can result in quantifiable value, reduction in timelines, and an overall increase in compliance.
The Need for Transparency
Key clinical stakeholders such as data management staff, biostatisticians, clinical operations staff, monitors, and site personnel often function separately, working and managing their tasks in silos. Providing real-time transparency for each of the various roles, such as collecting, reviewing, cleaning, and analyzing trial data, allows for clear oversight throughout the trial process. This visibility results in new alignments among these functions. Starting with risk assessment and Key Risk Indicators (KRIs), each stakeholder has greater visibility into and insight throughout the entire issue management and resolution workflow.
The Need for Standardization
Incorporating pre- and post-market data collection, along with real-world evidence (RWE), allows for additional insights and more holistic, informed decision-making throughout the device development period. Additionally, real-world clinical data – from registries or peer-reviewed medical journals – have successfully been used to support label expansions. Utilizing these multiple data sources in a standardized and harmonious way is essential for unique cross-study reporting, as well as transforming the way data is leveraged.
A Unified Solution Enables an Agile, Iterative Trial Approach
By addressing these three needs – efficiency, transparency, and standardization – medical device clinical affairs teams can face the evolving regulatory landscape and competitive pressures. Where and how to implement solutions that best address these needs can be overwhelming and is often thought to be too expensive. On the contrary, incorporating a unified solution can be achieved in a strategic and scalable manner.
Even without a formal initiative in place, requesting a technology overview from different vendors can provide an initial step for a clinical affairs team. The right technology partner can demonstrate the benefits of managing data in just a single study, regardless of the outsourcing strategy deployed. A fit-for-purpose solution can be implemented initially with little-to-no change management resources required. Then, the solution can expand as true quantitative value is demonstrated for operational efficiencies, stakeholder transparencies, and enhanced reporting from standardized data. Ultimately, with a unified solution, medical device clinical teams can make more holistic, informed decisions during trials.
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