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Maximizing Success in Medical Device Companies: Leveraging Public Databases

This session explores the value and potential risks of using public databases in medical device research and clinical trials. It discusses the challenges, benefits, and strategies to optimize the use of these databases for successful outcomes.

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Maximizing Success in Medical Device Companies: Leveraging Public Databases

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  1. Session IISafe PCI For Women David R Rutledge, Pharm.D., FCCP, FAHADirector, Worldwide Clinical Research Device Industry View

  2. Which Ultimately Determines a Medical Device Company’s Success? Protocol and ICF Sign-Offs SAP and mock table Sign-Offs EDC Build with Edit Checks Achieving FPI goal LPI/LPV goals ahead of timeline Database Lock ahead of timeline IFU Updates Timely, Valid and Positive Data NEJM, JAMA, and LANCET Articles Final Report Large data sets with tens of thousands of patients 2013 Abbott Vascular29JUL13 2

  3. TREATExperience with a Large Public Databases • Tiptoe into a public database • Anonymized patient data back to the patient’s source documents • New way of thinking shifting our thinking about a Sponsor’s commitment to “Innovation” • Designing trial then building the database • Accessing the database then designing the trial 2013 Abbott Vascular29JUL13

  4. Medical Device Companies Issues For Further Discussion Today 2013 Abbott Vascular29JUL13

  5. Tipping Point For Investment What’s our value proposition? • Venture Capitalist “You bet on the Jockey not the Horse” • Determine the “Tipping Point” between what Device companies can get from a public database and a Sponsor’s willingness to invest 2013 Abbott Vascular29JUL13

  6. Ability to Tweak a Public Database • On Demand (Response from Regulator or IRB/EC) • Product specific entry, e.g., expiration date, times • Clarify a safety field • Change in a clinical definition • Concomitant drug therapies • Early On During Enrollment • Inclusion/Exclusion criteria • Device line extensions/updates become available • Newer accessories become available • Scientific data become available during the trial, e.g., company or competitor, safety or efficacy TREAT IVTransradial WorkshopFourth Thinktank at FDA Headquarters 2013 Abbott Vascular29JUL13

  7. Initial EDC Build versus Amendment Releases*** Simulation = Set Targets and Negotiate *** 2013 Abbott Vascular29JUL13

  8. Is There an Appetite to Waive Portions of GCP ICH-E6 5.5.3a-g?    5.5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: (a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation). (b) Maintains SOPs for using these systems. (c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail). (d) Maintain a security system that prevents unauthorized access. (e) Maintain a list of the individuals who are authorized to make data changes (see 4.1.5 and 4.9.3). (f) Maintain adequate backup of the data. (g) Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing). 2013 Abbott Vascular29JUL13

  9. Medical Device Approval Trials Value of Large Public Databases Construct PerformanceGoals or ObjectivePerformance Criteriafor smaller, single-arm studies Medical Device companies prefer to focus on“Out of Control Group” 2013 Abbott Vascular29JUL13

  10. Issues For Further Discussion Standard DefinitionsOnce you go beyond one database, there are no standard definitions for data elements, e.g., sex/gender/gender at birth, MI, Race/Cultural Origin, Renal Failure/SrCr, Date of Birth/Day of Birth Research CommunityBy the time the DB gets large and robust, the research community has gone forward, e.g., “Practice lags behind research.” PARTNERSHIPWhat does “partnership” mean? Strategic Partnerships? What is the legal framework? 2013 Abbott Vascular29JUL13

  11. Audit Readiness? No clear ownership and accountability of database 2013 Abbott Vascular29JUL13

  12. Issues For Further Discussion(cont.) • How do we improve site relationships/management? • Sites get upset too • They are busy • Are screening failures more easily accessible? • Is this a real aid to site selection? • Experience and expertise of the interventionalist • PI resources to conduct study • Cross discipline expertise for the interventionalist • Is this a real aid to patient selection? 2013 Abbott Vascular29JUL13

  13. Benefits vs. Risks: Public Database Risks to Medical Device Companies High Low Moderate +/-- +++ ++++ High Benefits to Companies --- +++ ++/-- Moderate ++/- --- ---- Low Can FDA, public databases, and medical device companiesmitigate factors for cost-effective IDE approvals? TREAT IVTransradial WorkshopFourth Thinktank at FDA Headquarters 2013 Abbott Vascular29JUL13

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