Applying Sound Research Practices in Development of Medical Devices

Medical device and diagnostic companies face greater demand to provide clinical evidence of product efficacy than ever before. Scrutiny not only from regulators, but from healthcare systems, physicians, and even patients, has prompted more device companies to perform clinical trials to meet regulatory requirements, differentiate their products, and improve the likelihood of commercial success. While these are similar to well-established pharma clinical studies, there are significant differences. This webinar will look at best practices for running medical device clinical trials.

To understand this trend, it’s vital to understand the rationale for development of ISO 14155:2011, which addresses the design and conduct of device clinical trials, in comparison with the ICH good clinical practice standards. We will survey the regulatory landscape in the U.S. and Europe and examine study start-up procedures and the need to develop a clinical investigational plan with clear inclusion and exclusion criteria. These provide an absolute standard for defining the study population and ensuring subject safety.

Choosing the best sites and investigators and engaging the right subjects — especially when studying small populations —is fundamental to successful trials. Vendor selection and staff training are critical as well. Investing time in getting it right from the beginning is foundational to the quality-by-design principles that are increasingly prevalent in the clinical research industry.

Additionally, safety reporting is essential to identifying device deficiencies, adverse effects, and factors that could affect device operators. Good documentation practices, including version control, dating, and signatures, require careful consideration. We will discuss how these practices apply to consent forms, conflict-of-interest documentation, trial master files, monitoring plans, data protection, translations, and risk assessments.

Speakers

Joanne Emmett, Vice President, Medical Device, Premier Research

Joanne Emmett has been part of the clinical research industry for 20+ years with a keen focus on operational design and delivery. Ms. Emmett started her career in academia within transplant research and proceeded on to cardiovascular research involving valve and imaging trials. Once joining the CRO business space in 1995, she was engaged as a CRA, LCRA and Project Manager working on trials in CNS, Oncology, Respiratory, Cardiovascular Device and several diagnostic programs. Ms. Emmett took her front-line delivery experience to the next level and moved into oversight and department leadership specializing in Clinical and Project Management Delivery, spending time at PRA and joining Premier Research in early 2011.

Since then, Ms. Emmett, has been responsible for the operational delivery structures and planning for both clinical and project management. She has focused on the key needs and standards within therapeutic and medical device and ensuring core process designations for staffing and oversight, including the unique regulatory and scientific avenues required for medical device.

Ms. Emmett has been engaged over her career with ACRP, chairing the Poster Committee in 2006 and moving onto Chair the Annual ACRP meeting in 2007. She also spent time with development and implementation of the Post Graduate Clinical Research Program at Humber College in Toronto. Ms. Emmett has her PMP designation, Management and Business Administration Certificate from the American Management and Business Administration Institute, CCRA from ACRP, Post Graduate Clinical Research Certification and BSc from the University of Western Ontario in London, Canada.

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Nicky Dodsworth, Vice President, Global Quality Assurance, Premier Research

Nicky Dodsworth is currently Vice-President Quality Assurance, Risk & Compliance for Premier Research with responsibility for Pharmaceutical and medical device studies.

Nicky is an active member of European Forum for Good Clinical Practice (EFGCP), in 2011 she was appointed Chair of the Education Working Party and is a member of the Audit Working Party. Nicky has conducted widespread training for various groups and has presented in 14 different countries. During 2010, she started to run the recently accredited EMWA Workshop on Quality Awareness in CSR Development. She is a Senior Associate Member of the Royal Society of Medicine. In 2009 Nicky became a Chartered Scientist, an award from the Science Council in the UK which is awarded to individuals who are professional scientists practicing and/or advancing science and for whom this is an integral part of their daily work. Nicky has worked closely with the Institute of Clinical Research since 1996, she is currently Co-Chair of the GCP Forum and she also works closely with the Ethics Forum. In July 2011, Nicky became a member of the Research Quality Assurance, West & Wales Organising Group which promotes information exchange at a regional level.

Nicky has written many publications, including addressing risk mitigation in clinical research, quality by design and risk management, risk based approaches, training and education, auditing and inspections, fraud and misconduct, ISO 14155, implementing quality in times of change, improving quality through metrics, standards for Ethics Committees in Europe, Standard Operating Procedures and running trials in Eastern Europe and Russia. Nicky has assisted in preparation of the 4th Edition of Fraud and Misconduct, Royal Society of Medicine Press, by writing the chapter on enhanced audits. More recently she has written a chapter on audits and inspections for the Oxford Handbook of Clinical and Healthcare Research. She has given over 60 lectures and presentations with various audiences globally, many from academia and the NHS on clinical trials, good clinical practice, quality, risk assessment, informed consent, audits and audit findings, fraud and misconduct as well as on Ethics Committees.

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