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John Kilmartin IMDA Regulatory Steering Committee Chair Senior Regulatory Affairs Director Medtronic Ireland. Overview of the Current Global Regulatory and Clinical landscape. Today (An Industry Perspective). MedTech sector at a glance Clinical trial infrastructure
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John Kilmartin IMDA Regulatory Steering Committee ChairSenior Regulatory Affairs Director Medtronic Ireland Overview of the Current Global Regulatory and Clinical landscape
Today (An Industry Perspective) • MedTech sector at a glance • Clinical trial infrastructure • Are we on the right path ? • Current environment for clinical studies • Global trends in clinical studies • What are other countries doing ? • Conclusions/thoughts
Are We on the Right Path ? • MedTech cluster (indigenous and multinationals) • Its happening on the commercial and R&D fronts • Small country, ability to network • Can do attitude, make it happen • The pieces of the jigsaw seem to be here
Clinical Trial Infrastructure • Competent Authority ICRIN Ethics Academic institutions Patients Industry CRF’s IMDA Clinicians ??? • Can we put all the pieces together ?
Thoughts • 10 years of good intentions/reports! • Past 2-3 years have shown real progress/willingness • KEY: Need each stakeholder to look at themselves • A few small wins will make a big difference • Needs impetus and examples that we can share • How do we promote a culture of clinical research ?
Lets look at the Current Environmentfor Clinical Studies Increasingly stringent safety requirements (increased patientnumbers, more trials, longer follow-up etc.) High level of scrutiny to ensurereturn of investment Challenge for regulators to keep pace with rapidly developing technologies
Lets look at Global Trends in Clinical Trials Conduct Observation (Cause?) • 1980’s – Increased regulation in US (FDA) • FDA Acceptance of European clinical data (2008) • Development of regulations & clinical trial infrastructure in Europe (+ others) Observation(Effect?) • Migration of clinical trials to Europe • Migration of Clinical trials to CEE, Lat Am, India, China & Australia/New Zealand etc.
Data from Clinicaltrials.gov • Global – 12,373 Medical device clinical trials • US – 5,338 • Europe– 3,756 • Ireland – 44 Germany - 1076 France - 790 UK - 570 Italy – 500 80% !!
US FDA: Reversing the trend ? • April 9, 2012, launch of "Innovation Pathway 2.0" - tool for FDA to evaluate FIH clinical trials • Evolving system with the goal of making the regulatory process more efficient and timely • Improving collaboration between FDA and innovators early in the process, prior to pre-market submission • Currently 9 device companies selected into the early feasabilitypilot program
So what is happening in the rest of the world? • What are other countries or regions doing that we need to be aware of?
Slide taken from a US presentation (focusing on Regulatory burden) • Where to conduct a clinical trial? Western Europe: Moderate Regulatory Burden North America: High Regulatory Burden Greater Asia: Growing Area of Interest Japan: High Regulatory Burden Africa: Challenging Politically and Varied Regulations South America: Complicated & Varied Regulations Australia / New Zealand: Low Regulatory Burden
Australia • Language:English ispeaking, little/no communication problems and little (if any) translation needs • Health Care: 1st world health care system, clinical outcomes are easily translatable to European and US populations • Population: Australia is a big country but its major cities are densely populated which provide a good patient population • Well established CRO network • Favorable place to conduct research, Fast activation time • HREC’s – pivotal role in reviewing scientific and ethical aspect of trial proposals • Reasonable regulatory environment: • CTN – HREC and hospital review & approval, TGA notification only • CTX – TGA review & approval, HREC and hospital approval
Central and Eastern Europe 29 countries , total population over 400 million people (including Russia) Benefits: • Attractive destinations for clinical trials - low cost & cultural barriers • Deliver high quality data and more efficient regulatory processes when compared to other emerging markets • Working to bring their regulations in line with EU requirements- clearer rules & greater stability in fee requirements Challenges: • Timelines • Document requirements by regulatory bodies • Costs of process • Language barrier • Lack of understanding of international regulations ?
Latin America • Becoming a preferred destination for clinical trials • 2005 to 2008: 30% increase in participation in clinical trials Benefits: • Large subject pool concentrated in urban areas - Lower costs • Well-qualified medical professionals • Reliable, quality data - high compliance and completion rates • Less competition due to less clinical trials • US: growth rate 7% / * trial density - 120 • Brazil: growth rates 16% / trial densities - 4 Challenges: • Inconsistent legal environment • Cultural and national differences • Different regulatory environments • Intellectual property concerns • Post study requirements *(number of recruiting sites divided by country population in millions)
Fast growinghealthcare economy(annual rate of 15%), huge population, and large pool of well-educated, English-speaking medical professionals Benefits Well-qualified investigators and well-run sites Low cost (40-60% cheaper than US) and rapid implementation of trials Make-up of the patient population (genetic diversity) The regulatory environment Proven data quality India
Conclusion • Many countries are available/open for business • Trends in certain countries can vary (e.g. FDA – early feasibility programme) • Within Europe, lots of opportunities STILL exist • Ireland punches below its weight ? • What do we need to do to promote future investment in ClinicalTrials in Ireland? • Acknowledge FIM vs. pre-market vs. post-market • PATIENT ACCESS TO NEW TECHNOLOGIES • Serious of small steps – today is another step in the right direction
Thank You Enjoy today Questions ? Acknowledge – Tanja Lennon and Taragh Keily
Europe - what is changing ? CURRENT SITUATION • Medical Devices Directive • Amendments via 2007/47/EC • Today: Proposed Revisions to the existing Directives WHAT MIGHT CHANGE ? • Introduces concept of ‘sponsor’ ? • New role of Member States in ensuring ethical reviews ? • Single application via the database for multi country investigations ? • Lead/ Co-ordinating CA appointed ? • Notification of Post Market Studies (if additional patient burden, interventional)?
EU clinical data requirements To support CE marking requirements, device must be • Safe • Perform as intended • Positive risk/benefit ratio • lower risk devices • relevant scientific literature to support the ER’s • combination of data - clinical investigations and relevant scientific literature. • higher risk devices • expectation is that CI is conducted unless it is duly justified to rely on existing clinical data
US clinical data requirements 2 phases – pilot/feasibility and pivotal studies Pilot/feasibility: • Establish safety • Assist in design of the pivotal trial • Generally less than 100 patients, small number of sites Pivotal: • Demonstrate that device is safe and effective • Prospective, randomized controlled study, high patient numbers / multiple sites For class III devices • Demonstrate reasonable safety and effectiveness • Premarket approval required to support device claims For class II devices • Increased demand for clinical data For both classes, if device is not exempt, IDE application is required