全球市场进入：如何建立医疗器械临床试验以满足全球监管要求

Global Market Entry:How to set up medical deviceclinical trials to meet globalregulatory requirements KENNETH RAYL, Director of Clinical Affairs, IQVIA MedTechNIMA AKHLAGHI, Ph.D., Director, Digital Health & Imaging Center Lead, IQVIA MedTechHAMIDREZA ALIDOUSTI, MENG, Ph.D., Director, Regulatory Affairs – Europe, IQVIA MedTechMICHELLE BULLIARD, Vice President, Real World Solutions, IQVIA MedTechCHAVA ZIBMAN, Ph.D., Principal Statistician, IQVIA MedTech Develop regulatory and clinical strategiesin parallel Global Market Entry: Howto set up medical deviceclinical trials to meet globalregulatory requirements For efficiency and to ease the submission process, werecommend medical device manufacturers integrateregulatory strategy into clinical development as earlyas possible. These two teams must continue to work inparallel throughout the product lifecycle. Regulatory authorities worldwide have raised the bar onmedical device clinical data requirements. Compared to adecade ago, agencies such as the U.S. FDA, the EuropeanCommission, the UK’s Medicines and Healthcareproducts Regulatory Agency (MHRA) and Japan’sPharmaceuticals and Medical Devices Agency (PMDA)all demand more robust data on long-term safety andeffectiveness, among other areas. Manufacturers must determine the product’s intendeduse, indications for use, regulatory pathway, andregulatory requirements before running a clinical study.Clinical information impacts regulatory strategy, whilethe regulatory pathway dictates requirements aroundstudy design, data collection methods, and patientpopulation, among others. Waiting to factor in regulatoryconsiderations later often leads to costly rework to resolvedata discrepancies, to collect additional data, or to amendstudy protocols mid-execution. Many regulatory agencies offer formal programsthat allow manufacturers to engage in earlydiscussions which helps clarify the regulatory pathand expectations. The FDA’s Q-Submission programenables manufacturers to receive specific feedbackon regulatory pathways and regulatory requirements,including study design and submission preparation.1The European Commission (EC) offers scientificadvice in advance of clinical investigations for ClassIII and Class IIb active medical devices intendedto administer or remove medicines.2In Japan, thePMDA’s Pre-Submission Consultation Program includesgeneral and preliminary meetings, several types ofpre-submission consultations for new and/or high-risk devices, and an RS General Consultation forprocedural questions and development planning.3 Data used to secure regulatory clearance in the U.S.may also support market authorization in other regions.Because regulatory requirements vary by country, aproactive approach to data collection helps bridge gapsacross multiple markets, including the EU and Japan. In this white paper, IQVIA MedTech and MCRA expertsshare their expertise on how to design clinical studiesto support a global regulatory strategy. Topicsdiscussed include: •How to meet global regulatory requirements with onestudy design These programs are particularly valuable forcomplex or novel devices without a clear predicate orestablished regulatory precedent. Early engagementhelps align data requirements across multipleagencies, increasing the likelihood that a single well-designed study can support submissions in more thanone market. •The role of real-world evidence across pre- and post-market activities •Key statistical considerations when evaluatingregulatory data •How to build a clear regulatory pathway across yourproduct’s lifecycle The U.S., EU, Japan, and regulatory bodies in otherregions, including the UK and Canada, all havemechanisms to provide regulatory and scientific advice.Engage with these officials as early as feasible to get asolid understanding of their respective requirements forbringing a device to market. Before requesting a meeting, have at least the followingin place: •Intended use and indications for use •Device descriptions and workflow •Proposed regulatory pathway •A study design synopsis, including primary objective,endpoints, and intended patient population A three-step framework for a global regulatory strategy 2.Identify where requirements overlap and wherethey diverge.Most major market requirementsshare common ground; the gaps are manageablewith the right upfront analysis. A harmonizedevidence generation plan that addresses theoverlaps efficiently and fills the gaps deliberatelyreduces the risk of repeat studies. Clinical data collection for multiple regulatory bodiesrequires a prospective approach with ongoingcollaboration between regulatory and clinical teams. 1.Define intended use and map your marketsearly.Know where you’re going — and in whatsequence — before designing your study.A precise intended use statement dictatesdevice classification, regulatory pathway, andevidence requirements in every target market.A clear picture of the clinical claim and deviceworkflow helps ensure