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CDRH Offers Peak Into Plans for Early Feasibility Studies, Use of External Evidence

Posted 06 September 2018 | By Ana Mulero 

CDRH Offers Peak Into Plans for Early Feasibility Studies, Use of External Evidence

Officials from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration during a forum on Wednesday touted a new pilot program on external evidence use and an early feasibility studies (EFS) report that help chart the course of action to follow.

New initiatives have been aimed at further integration of external evidence into regulatory decision-making, as compelled by law, in support of greater and more timely patient access to devices. This goal involves stressing the benefits of conducting US-based EFS, with guidance released in 2013 to encourage program participation.

External evidence and EFS came under the spotlight during the Medical Device Innovation Consortium (MDIC) annual public forum, pointing to some progress but more hard work ahead.

An FDA/MDIC pilot program set to be launched sometime this year seeks to break down current barriers on conducting domestic EFS, which provide early insights into device performance in proposed patient populations for achieving cost and time savings and hep familiarize agency staff with a device earlier in the total product lifecycle. 

This work is essential to enable more EFS, including first-in-human clinical studies, in the US so that patients can have access to innovative and potentially lifesaving devices earlier in the process overall, said Chip Hance, CEO of private equity firm Regatta Medical. Progress on this front is depicted in the MDIC-developed graphic below.
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This pilot program falls under an MDIC-led demonstration project already underway, which aims to tackle common issues related to EFS administrative processes, including approval of investigational device exemption (IDE) applications, Institutional Review Board approval, contract execution and first subject enrollment. 

Yet a recent MDIC analysis on EFS performance metrics—obtained from about 22% of all IDEs for EFS between 2015 and 2017—suggests the three non-regulatory processes were more time-consuming among the responding 13 company sponsors and 50 clinical sites, compared to those performed within CDRH. The findings reflected in the graphic below were discussed at a forum session, raising concerns over site contracting and patient enrollment issues in particular.
 
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A new master contract agreement resource, a perfomance metrics report onand a blueprint for ensuring US EFS success were developed and published under the MDIC project. 

The FDA/MDIC pilot program, for which more than 50 sites have already applied to participate, will be expanded to other disease areas beyond its initial cardiovascular focus. This work will be crucial to drive early innovation throughout the entire device sector, David Holmes, a Mayo Clinic cardiologist, told Focus

A total of "seven major sponsors who were conducting EFS in the second half of this year and said they will take on the MDIC templates, processes and network" to "demonstrate that these are advantages" to what has been historically done and can be used as a learning environment moving forward, Hance said, adding that FDA Commissioner Scott Gottlieb has supported not just the significance, but also the feasibility of the objectives.

The proposed goal for addressing the non-regulatory issues associated with EFS is for each one of these three processes to be completed within 60 days based on a streamlined contracting process, among other deliverables.

External Evidence

Meanwhile, a separate pilot program on incorporating external evidence into pre- and postmarket regulatory decision-making will be launched this fall. This collaboration between MDIC and CDRH, among others, seeks to support the community needed to ensure long-term success of virtual trial designs using Bayesian-designed tools, building off of FDA guidance finalized in 2016. 

It seeks to create a regulatory paradigm shift to keep pace with innovation, though it is not the only proposal of its kind within CDRH. Another involves regulation on digital health products.

The project provides an opportunity to create a digital library for the sharing of information between firms and regulators using computer modeling and simulation, said Ted Lystig, director of corporate biostatistics at Medtronic.

The library infrastucture proposed by MDIC as part of this project is illustrated in the graphic below. 
 
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This project could alllow for the combination of data from various different sources in a quantitative and quantifiable shared framework, which could in turm help reduce patient exposure to clinical trials and achieve cost savings, said Kyle Myers, director at CDRH's Division of Imaging Diagnostics and Software Reliability. 

The working group for this pilot program will initially focus on issue such as device characterizations and the potential roles of Medical Device Development Tools and the National Evaluation System for health Technology (NEST)—an MDIC-run program.

It would be helpful to use NEST as the foundation for the pilot to create a common data-sharing framework that can be applied on an international scale for purposes such as developing product portfolios, Lystig told Focus.

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