Four Practical Approaches To Managing A More Effective Device Trial

Four practical approaches to managing a more effective device trial Blair Keagy, MD, CEO, Medical Products Analytics David Levin, Vice President, Clinipace June 10, 2009

Sponsors Commercial Feasibility Analysis | Clinical Development Digital Clinical Research Organization (dCRO)

Device and drug trials are not all alike ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],Reasons devices fail to achieve commercial success

Objects in the mirror are farther than they appear ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

FDA approval doesn’t guarantee reimbursement Pre-IDE meeting is very important

{Great} reimbursement ideas from the government Prospective Payment System Inpatient Outpatient

HCPCS (Healthcare Common Procedure Coding System) Level I ,[object Object],[object Object],[object Object],Level II ,[object Object],[object Object],SADMERC ,[object Object],[object Object],DMEPOS ,[object Object],[object Object]

2,800 Level II HCPCS Codes A Codes Miscellaneous services and supplies B Codes Enteral or parenteral treatment C Codes Drugs and biologics (pass-through) D Codes Dental codes E Codes Durable medical equipment H Codes Alcohol and drug abuse treatment J Codes Drugs that cannot be self-administered Q Codes Biologics such as dermagraft

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Reimbursement considerations when designing a trial

Product use impacts trial design and operations Hospitals ,[object Object],[object Object],Physician Offices ,[object Object],[object Object],Inpatients ,[object Object],[object Object],Outpatients ,[object Object],[object Object],Laboratories ,[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Clinical efficacy must be proven

AHRQ Analysis of Aortic Endografts

Hospitals make purchasing decisions

Yet, device and drug trials are alike ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Clinical trials are a major investment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Technology is more efficient, but requires more planning Technology-Driven Trials [1997 - ] Design Conduct Analysis Low High Cost 30% Reduction

Successful technology deployment requires focus on process Management Operations Strategy & Planning Design Enrollment Data Capture/Mgt Analysis Regulatory Modeling/Simulation Site/Patient Recruitment Submission Protocol Design Electronic Data Capture [EDC] IVRS PRO Study/Project Management Reporting / Analytics CDM Clinical Trial Portfolio Management IIR / Grants Management

Visibility is king Management Operations Strategy & Planning Start - Up Conduct Close - Out Project Milestones Queries Patient Accrual CRF Status Monitoring Activities

Questions & Answers Commercial Feasibility Analysis | Clinical Development Blair Keagy, MD [email_address] www.mpanalytics.com Digital Clinical Research Organization (dCRO) David Levin [email_address] www.clinipace.com

Four Practical Approaches To Managing A More Effective Device Trial

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