With the increasing demand from various regulatory agencies for prospective clinical data as part of the clinical evidence for market access of medical devices, the financial burden of medical device companies continues to increase significantly. Simultaneously, however, the acceptance of foreign data by those regulatory agencies has also become more common, provided that certain levels of compliance can be demonstrated and elements, such as local standard of care or particular race-induced differences, are being carefully considered. But is it really that simple?
For certain devices it may indeed remain a challenge to go down the route of “one clinical investigation fits all.” However, for many devices, upfront research and planning toward global use of clinical data may pay off both in reduced time and costs to get your product to market.
Carefully outlining the intended use and claims for the medical device remains a vital step prior to diving into research and planning for the globalization of clinical data. The claims and preliminary hypotheses related to such claims provide the basis for a potential study design. Several questions still need to be answered. Does one given study design cover all regulatory requirements? Do we need to include patients from different parts of the world or can we concentrate the clinical investigation in one region? Are there marketing or reimbursement elements that make it important to include sites in different markets?
However, a single clinical investigation cannot always fit multiple regulatory purposes. Using other methods can help create sub-groups in a clinical investigation or conducting interim analyses for various regulatory objections are alternative solutions that still allow manufacturers to reduce premarket costs.
Some markets with high patient volumes have recently changed their regulatory requirements. China is one of them. And looking at the recently announced changes from the China Food and Drug Administration (CFDA), including Chinese sites in a global study may become feasible. Indeed, the CFDA’s acceptance of foreign preclinical data may reduce the burden of the currently mandatory local type-testing prior to ethics committee submissions and bring new opportunities for expanding global clinical studies into China earlier than previously thought.
A point not to be taken lightly, though, is global Good Clinical Practice (CGP) compliance. The TC 194 WG 4 on ISO 14155 has been focusing a lot on getting global acceptance, thereby making it easier for medical device manufacturers to have one standard methodology applied throughout the world. There will always remain some subtle national differences such as language requirements, reporting requirements and others, however conducting a clinical investigation under one set of GCP requirements has become more of a reality by using ISO 141555.
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Reprinted with the author's permission. Giroud presented this topic at Brandwood Biomedical’s Asia Pacific Device Summit earlier this year. Visit www.asiapacificdevicesummit.com for 2019 dates being confirmed soon.
Danielle Giroud has over 30 years of industry experience and is founder and senior faculty board member of the World Medical Device Organization (WMDO). She is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.
Giroud is also currently the organizer for the expert group on clinical investigations, TC 194 WG4 for the ISO 14155 as well as liaison with the European Union Commission’s Clinical Investigation and Evaluation (CIE) task force.