Advice for Sponsors Conducting Medical Device Trials Under EU Regulations

DiabetesThe European Union is continuously improving and updating its legislation for the approval system of high tech medical devices that mirrors the approval process of the FDA. CROS NT outlines its suggestions for conducting more efficient studies without increasing your budget.

The medical device approval process has generally been guided by national law where a conformity assessment is performed by a notified body and the device obtains a CE marking meaning it can be sold in the European Economic Area.

New legislation aims to eliminate the equivalence principle commonly used for market approval and would require more sophisticated clinical trials. This means trial costs are going to increase as there would be a need to collect additional clinical data to demonstrate efficacy and safety of a medical device.

In an effort to guarantee patient safety, the EU will require more follow up during post-market including more post-market studies. The EU, the European Medicines Agency and lawmakers for medical devices are pushing for greater data transparency in both drug and device studies. Device companies will need to prepare data in a traceable and readily available way to respond to an liability issues.

What can medical device companies do to conduct more efficient trials?

Medical device trials tend to have a lot of variance and therefore protocol and study design are crucial. Device studies have many factors to consider, such as small populations, site differences and unique study endpoints.

1. Expert Statisticians and Consultants 

Involving an expert statistician from the beginning can help with protocol development and study design, especially in the areas of adaptive trial design and Bayesian method. Since statisticians must factor in several variability elements such as changing sample size and unique endpoints, adaptive trial design can help account for these changes.

Device studies differ from drug trials in that statistical methods in device studies test for the estimation of effects while drug studies focus on hypothesis testing. Statisticians who can implement adaptive design can account for uncertainty in device studies – such as safety problems, unexpected treatment effects and high variance – by propspectively planning for modifications in aspects of the study design.

2. Incorporate Technology Solutions

Incorporating an EDC solution into your medical device trial can provide immediate feedback and more accessible trial information. This is essential when implementing an adaptive design approach so statisticians can make quick decisions.

Industry reports have indicated that the implementation of cloud computing technologies could speed up studies and possibly result in up to $400 million USD in savings. Cloud-based EDC systems allow for real-time data, immediate feedback and real-time data transfer for query management and faster data cleaning. In addition to better data quality, cloud-based systems allow for global, multi-center and multi-language studies to be organized in one single database. This becomes extremely efficient for statisticians studying metrics in real-time. Cloud service providers can implement security measures, including user and password protections, and HTTPS connections to ensure secure and private data transfers to meet tough data privacy laws.

3. Strategic Outsourcing Model

One way to reduce costs is to consider a centralized clinical data approach in which all data is kept with one specialized CRO. With potential cost savings of up to 40% due to the use of global libraries, all data management and biostatistics activities are centralized with the same vendor.

Medical Device companies should also consider a Functional Service Provision model in which scalable teams of resources in specific functions are available at daily or hourly rates. This may be an ideal option for medical device companies which, in addition to cutting costs, are looking for statistical expertise.

CROS NT and 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.