Combined Clinical Studies
Wien, 10.12.2024 – Text: Catarina Carrão Combination products Combination products are progressively integrating cutting edge, novel technologies that hold great promise for advancing patient care. Such innovative drug, biological product, device combinations have the potential to make treatments safer, more effective, or more convenient to patients. For example, drug-eluting stents may reduce the need for repeated […]
Harmonised European Standards
Wien, 18.11.2024 – Text: Catarina Carrão The General Framework for harmonised European Standards (hES) Under the MDR 2017/745 and IVDR 2017/746 regulations, harmonized European standards (hES) play an important role. The legislation only sets out the basic requirements that products must meet to be sold in the European Union (EU). The technical details and specific product features needed to meet these […]
Clinical Performance Studies of IVDs
Wien, 11.10.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) devices: clinical performance studies Despite extended transition periods and multiple guidelines, IVDR remains difficult to interpret and bringing devices into compliance requires additional efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance studies with the device and its analytes. As […]
eConsent
Wien, 01.09.2024 – Text: Catarina Carrão Introduction eConsent refers to the process of obtaining informed consent from participants in clinical trials using electronic systems and processes. This method involves using electronic tools, such as tablets, computers, or smartphones, to present information about the trial and to collect signatures from participants. Misconceptions eConsent and remote consent are often confused, […]
Clinical evidence: essential for both investors and regulators
Wien, 09.07.2024 – Text: Catarina Carrão Medical technology start-ups: popular demand The need for innovative healthcare solutions is high, as such medical technology start-ups are increasingly popular. Whether developing new technologies, devices, and/or software that has the ability to improve patient outcomes and reduce healthcare costs, the incentive is there to identify a niche and develop something new. However, […]
Is the Clinical Trials Enterprise broken and how can we fix it?
A report of the inaugural JAMA Summit Wien, 17.06.2024 – Text: Catarina Carrão The inaugural Journal of the American Medical Association (JAMA) Summit 1 was held last October and focused on clinical trials, the basis of evidence-based medicine. It was meant to address the provocative questions: Is the Clinical Trials Enterprise Broken? And How Can It Be Fixed? As such, an international group of invited clinical researchers, funders, regulators, policymakers, […]
International Clinical Trials Day: Data Centric Clinical Research
Wien, 20.05.2024 – Text: Catarina Carrão International Clinical Trials Day In May 2005, the European Clinical Research Infrastructures Network (ECRIN) begun celebrating the International Clinical Trials Day. This celebration yearly brings together patients, health policy actors, health authorities, clinical researchers, health professionals and citizens from across Europe and beyond to discuss issues related to multinational […]
Implementing the EU Health Technology Assessment Regulation (EU HTAR)
Wien, 24.04.2024 – Text: Catarina Carrão The development of health technologies is a key driver of economic growth and innovation in the European Union (EU), since health technologies constitute an innovative sector of the economy and form part of an overall market for healthcare expenditure that accounts for 10 % of the EU gross domestic […]
EU CTR: Transparency
Wien, 15.04.2024 – Text: Catarina Carrão In the end of January 2022, the EU CTR (EU/536/2014) came into effect within the European Union (EU), replacing the EU Clinical Trials Directive (2001/20/ EC). Under the EU CTR, a new EU database – the Clinical Trials Information System (CTIS) was created to provide a single-entry point for […]
EU MDR and The Need For Clinical Evidence
Wien, 12.03.2024 – Text: Catarina Carrão Since the establishment of the EU Medical Devices Regulation (MDR EU 2017/745), Notified Bodies (NBs) have their hands full evaluating the clinical evidence for such products as a critical step for manufacturers to renew or obtain a green door to the European Economic Area (EEA) market. Clinical evaluation: where […]
