Applied Clinical Trials
Initiative designed to boost understanding of medical device development in Europe.
The MedTech Europe Medical Technologies Working Party of the European Forum for Good Clinical Practice (EFGCP) has produced a roadmap that is designed to boost understanding of medical device development in Europe.
This initiative is aimed at answering the central question of what constitutes a high quality of clinical evidence for medical technology, in particular from an ethical, patient, clinical, and regulatory perspectives.
"New regulations under consideration in the EU focus on new technologies such as novel in vitro diagnostics (IVDs), companion diagnostics, and on the development of healthcare apps, all of which rely on information to deliver positive health outcomes," noted the EFGCP in a statement. "Gathering clinical evidence and knowing when and how to conduct clinical investigations for these new technologies is a challenge which still needs to be addressed."
The Working Party is determined to address these open questions and investigate the generation of clinical evidence for IVDs, companion diagnostics, and healthcare apps from the point of view of clinicians, patients, regulators, and product developers. To start the process, it is organizing a multi-stakeholder workshop on establishing best practices in clinical development of devices in this area. Called "Barriers and Pathways to Success," the event will take place in Belgrade, Serbia, May 7-8 at the Chamber of Commerce and Industry of Serbia.
This will be followed by a two-day workshop on "Ethics, Quality and Oversight in the Clinical Development of Medical Devices," to be held at University College London June 15-16. The Working Party is organizing another workshop on risk management and regulation at the Central Hospital of Luxembourg in October, and then a roundtable on combination drug/device products in Leiden, Netherlands, in January 2016. "A constructive and energetic year is planned, to make sure the medical technology sector has its own spotlight and that concrete solutions are found for the well-being of patients," said EFGCP chair Ingrid Klingmann, MD.
For more information, visit www.efgcp.eu.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.