Strengthening the Medical Device Clinical Trial Enterprise

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Presentation transcript:

Strengthening the Medical Device Clinical Trial Enterprise Owen Faris, Ph.D. Clinical Trials Director (acting) Office of Device Evaluation Center for Devices and Radiological Health

CDRH Strategic Priorities 2014/2015 Strengthen the Clinical Trial Enterprise Strike the Right Balance Between Premarket and Postmarket Data Collection Provide Excellent Customer Service

Strengthening the Clinical Trial Enterprise Goal: Improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular. Goal: Increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the U.S.

The IDE Challenge The IDE review process is an important part to protecting subjects in investigational device studies We also recognize, the sooner an IDE is approved, the sooner a potentially important technology can be available to US patients The IDE process has at times led to avoidable bottlenecks in the process We can and should look for ways to improve the process of FDA’s decision making for IDEs

What is CDRH doing? Established Clinical Trials Program and Clinical Trials Director (CTD) Established SOP for CTD involvement and review of certain IDE decisions. Focus on: Ensuring CDRH is “in the right place” Ensuring flexibility is applied where appropriate Increased communication with sponsors Established Early Feasibility Study (EFS) coordinators within Clinical Trials Program

30 Day IDE Review Round 1 DSAP* IDE SOP Provisions 10 Days FDA offers a teleconference to clarify reasons for decision 30 Day IDE Review Round 1 DSAP* * For Round 1 disapproval (DSAP) and approval with conditions (APCN) decisions, the clinical trials director (CTD) may review and request to meet with review team.

30 Day IDE Review Round 1 DSAP* IDE SOP Provisions FDA offers a teleconference to clarify reasons for decision 30 Day IDE Review Round 1 DSAP* 10 Days CTD included in 10-day t-con CTD and team meet internally Round 2 DSAP or APCN * For Round 1 disapproval (DSAP) and approval with conditions (APCN) decisions, the clinical trials director (CTD) may review and request to meet with review team.

30 Day IDE Review Round 1 DSAP* IDE SOP Provisions FDA offers a teleconference to clarify reasons for decision 30 Day IDE Review Round 1 DSAP* 10 Days CTD and team meet internally CTD included in 10-day t-con Round 2 DSAP or APCN CTD notified 5 days prior to decision letter Round 3+ DSAP or APCN * For Round 1 disapproval (DSAP) and approval with conditions (APCN) decisions, the clinical trials director (CTD) may review and request to meet with review team.

Clinical Trials Program Outcomes Helps ensure consistency in decision-making Facilitates sharing of best practices across divisions Encourages higher levels of interaction Helps prepare sponsor to respond 10-day meeting

FY2014 Goals and Results By September 30, 2014, compared to FY13 performance, CDRH sought to: Reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 25% Result: 34% reduction Reduce the overall median time to appropriate full IDE approval by 25% Result: 53% reduction

FY14 Performance * Values calculated on 10/31/13 and 10/31/14 respectively

FY14 Performance * Values calculated on 10/31/13 and 10/31/14 respectively

FY2015 Goals By June 30, 2015, compared to FY13 performance, CDRH seeks to: Reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 50% Reduce the overall median time to full appropriate IDE approval to 30 days. Increase the number of early feasibility/first-in-human IDE studies submitted to each premarket Division

Clinical Trials Program: Future Plans Continued monitoring of performance for IDEs in general and EFS IDEs Draft Benefit-Risk Guidance for IDEs Development of additional clinical trials training for CDRH review staff and external stakeholders Submission quality improvements

Submission Quality Meeting our FY15 goals will require work by both FDA and IDE sponsors Many IDE submissions fail to “tell the sponsor’s story” Many others fail to provide basic information needed to support FDA’s IDE review Interaction with sponsor during IDE review can help resolve minor issues, but improvements in submission quality are a critical component as well

Some major nonclinical reasons for IDE Deficiencies Device description Mechanical testing Biocompatibility Animal testing

Types of questions that relate to submission quality Describe device components and materials Describe principle of operation and key characteristics Clarify version of device tested compared to version for clinical study Clarify what testing was done with rationale Provide adequate description of test conditions, success criteria, and results

Conclusions Strengthening the Clinical Trial Enterprise is a high priority for CDRH. We have made major progress in the past year. However, much work remains and future progress will be a joint effort between FDA and our external stakeholders.