Last week, the FDA announced that it approved an accelerated review process and pathway for critical medical devices. The goal behind this effort is to get medical devices to market faster, particularly devices “that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions”. The accelerated pathway gives these devices the opportunity to “jump the queue” when it comes to approvals.
In terms of clinical data, there are some noteworthy aspects of this new approval process:
- Clinical data requirements will be reduced through the use of clinical or surrogate endpoints
- Increased reliance on post-market data at avoid longer, time-consuming trials for premarket data
While this announcement may be good news for many late stage device companies pushing market entry, medical device companies need to be prepared now more than ever to present quality clinical data results.
Looking at Strategic Outsourcing and Clinical Data Considerations
According to a survey in late 2014 by Best Practices and reported by MDDI online, only 27% of medical device companies outsource data analysis while 40% outsource data management. These outsourcing decisions are undoubtedly influenced by costs, and medical device companies also site therapeutic area expertise and geographical relevance as important outsourcing decisions.
While these factors are certainly important, a company’s approach to quality data results starts in the early phases of device development and outsourcing strategy. Using a variety of full service CROs to obtain the right therapeutic expertise or geographic locations can result in dispersed clinical data across a program of studies. Alternatively, relying on in-house resources who are not specialized in data analysis and reporting can lead to lower quality results and possible rescue studies down the road.
Centralizing clinical data with a specialized vendor for all studies related to a single product leads to standardized data formats, common assessment methods, improved traceability and collective communication for regulatory submissions.
This model is particularly efficient for post-market studies with larger patient pools. Through the use of global libraries, data management costs can be reduced by up to 40%.
CROS NT and Medical Device Studies
CROS NT is exhibiting at MedTec Europe in Stuttgart, Germany April 21-23 at Booth #3h55. Be sure to visit our stand at Europe’s premier medical device conference to learn about how we can optimize clinical data collection, reporting and analysis for medical device studies.
CROS NT has worked with multiple start up and late stage device companies, attended and presented results at regulatory body panel meetings and supported with full spectrum of statistical and data management services. This effort includes work on novel, Class III devices and consulting on de novo Class II devices.CROS NT is capable of providing services for post-approval studies including statistical sections and sample justification.
CROS NT is capable of providing services for post-approval studies including statistical sections and sample justification. We understand the changing expectations of the regulatory agencies in terms of data collected so we can produce statistical analyses that meet their expectations.
CROS NT can support in the conduct of medical device trials by:
- Providing expert biostatisticians with a track record of conducting medical device studies, applying the equivalence principle and managing large sample sizes and unique endpoints
- Choosing the right technology solutions for immediate feedback, more accessible trial information and higher data quality
- Measuring uncertainty in medical device trials through an adaptive design approach including safety problems, unexpected treatment effects, high variance and effects in secondary endpoints/subpopulations
- Support and representation for EMA and FDA submissions