Globalization of Clinical Trials: Mutual acceptance of Medical Device data
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Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
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Globalization of Clinical Trials: Mutual acceptance of Medical Device data
- 1. GLOBALIZATION OF CLINICAL TRIALS: MUTUAL RECOGNITION OF CLINICAL STUDY RESULTS Annet Muetstege| CTMD, 21 September 2016
- 2. Change in Clinical Trial distribution • Proportion of clinical trials in the US down ~18% • Proportion of trials in EU up ~9% • Proportion of trials in Japan up ~7% CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 2 George M et al. Current Clinical Pharmacology, 8, 115-123, 2013
- 3. Why use foreign data? Limit redundant duplication • Resources - companies and regulators • Ethics – study participants Faster access to innovative care • Subject recruitment • Less studies CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 3
- 4. Clinical Trial execution - GCPs CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 4
- 5. GCP consistency GCPs becoming alike • Rights, safety, welfare of trial participants • Scientific integrity of trial methods • Accuracy of data • Reliability as a basis for RA decision making Non substantive/ administrative differences exist • Financial disclosure, IRB/ EC requirements, … • Take into account ISO 14155 – acknowledged as standard for medical device studies CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 5 RAPS regulatoryfocus. January 2013
- 6. ISO 14155:2011 2015-Mar-26 IMDRF Statement on Use of ISO 14155:2011 • Acknowledged by main regions can serve as global standard to medical device GCP’s Facilitates acceptance medical device foreign data Not specifically address mutual acceptance CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 6
- 7. ICH harmonised guidelines - medicine ICH E5 - Ethnic factors in the acceptability of foreign clinical data • the characteristics of foreign clinical data and the regulatory strategies to minimize duplication of clinical data and facilitate acceptance of foreign clinical data in a new region • the use of bridging studies, when necessary, to allow extrapolation of foreign clinical data to a new region A clinical study in the new region to provide information on the pharmacodynamics or clinical safety, efficacy, dosage and dose regimen in the new region CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 7
- 8. Standards on foreign data – devices US/ FDA • March 2001 – Guidance for Industry - Acceptance of Foreign Clinical Studies • April 2015 – Draft guidance Acceptance of Medical Device Clinical Data from Studies Conducted Outside the US Japan • March 1997/ 2006 - MHW 479: Handling of data of clinical studies for medical devices conducted in foreign countries Europe • June 2016 - MEDDEV 2.7/1 revision 4 CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 8
- 9. Requirements in brief United States/ Japan/ Europe 1. Clinical studies in conformance with international standards, such as Declaration of Helsinki, GCP, and ISO 14155 2. Clinical data on the applicable study population and clinical condition 3. Methodology should meet local standards, including scientific appraisal CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 9
- 10. Challenges with foreign data CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 10 Dunder. Issues on Acceptance of Foreign Clinical Data in Europe from a Regulatory Perspective.
- 11. Medical devices? ■ Anatomy ■ Constitution CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 11
- 12. Racial skin differences CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 12 DuPlesis. Dissertation. 2012
- 13. Aspects on comparability Clinical study population • General charateristics (genetic, phenotypic) • Confounding clinical conditions Clinical study methodology • Local standard of care – comparator group • Performance/ effectiveness - endpoints CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 13
- 14. Origin PMDA Clinical Data CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 14 https://www.pmda.go.jp/english/about-pmda/0004.html#clinicaldata ■ Acceptance of sole foreign data substantial ~60% ■ Decreased contribution of Japanse clinical data 0 20 40 60 80 100 2006 2007 2008 2009 2010 2011 ProportionofClinicalTrials Time period Origin PMDA clinical data Japan only Japan + foreign Foreign only
- 15. Origin PMA Clinical Data CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 15 ■ Acceptance of foreign data increased ~4% ■ > 60% US data only 0 20 40 60 80 100 M,J,J 2001 M,J,J 2006 M,J,J 2011 M,J,J 2016 ProportionofClinicalTrials Time period Origin PMA Safety & Effectiveness data US only US+OUS OUS only Muetstege. Personal analysis. 2016
- 16. What about Europe? CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 16 ■ Applicability rather than origin ■ Local implementation after CE-mark often requires additional post-market studies
- 17. Conclusion • The clinical trial as well regulatory environments favor mutual use of clinical data ■ Electronic means, standards • Changes in clinical trial execution are not reflected in similar developments in foreign clinical data acceptance • Other factors seem to outweigh the benefits ■ Population differences, local requirements/ standards • Medical device bridging studies CTMD, 21-Sep-2016 ACS Globalization Clinical Trials 17
- 18. 18 Questions? Applied Clinical Services BV Annet.muetstege@appliedclinicalservices.com