Joanne Emmett, Vice President, Medical Device, Premier Research
Nicky Dodsworth, Vice President, Global Quality Assurance, Premier Research
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.