NESTcc adds laboratory and patient engagement experts to Governing Committee CONTEXT: The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), Continue Reading
Implications of the upcoming changes to French ATU (Autorisation Temporaire d’Utilisation) programme CONTEXT: From July of 2021manufacturers will be required to make all early access authorisation requests to the HAS Continue Reading
CONTEXT: Opinion piece on decentralised trials. Interesting timing ahead of the DIA making the topic a major platform for this year’s get together. IMPACT: Low READ TIME: 2 mins Continue Reading
CONTEXT: A report on how innovation in the MedTech business is enabling health care providers to transform patient care to a more de-centralised model | US only IMPACT: Low READ Continue Reading
CONTEXT: “Data monetisation in the Med Tech environment”. I have to be honest – I’ve read this article twice and still not entirely sure what this actually means in real Continue Reading
CONTEXT: Mostly advert for cox platform, but interesting EMR based use of RWD – stretching the definition of a decentralised study though, US Only IMPACT: RWE insights based on de-identified Continue Reading
CONTEXT: BMJ article describing a framework for RWE study design toencourage reproducibility. The framework is intended for use in studieslooking at effectiveness and safety of medical products and claims to Continue Reading
COMMENTS: Good story on use of RWE / RWR in oncology. READ TIME: 2 mins *1. “Sir Mick Peake, clinical director for the Centre for Cancer Outcomes within UCLH’s Cancer Continue Reading
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others Continue Reading
EXPERT NOTES: CONTEXT: EU, Commercial RWD Data Source IMPACT: Access to EU RWD, drive cutting edge improvements in patient outcome Time Taken = 3 mins QUOTES FROM SOURCE: 1. “NEW Continue Reading
