Navidence的动态

Want to simultaneously create your operational definitions, value sets and code lists as you create your RWE Study protocols? RWE Sherpa can help you. Here is a taster of an overview given by our CEO Aaron Kamauu MD MS MPH on how RWE Sherpa can model your RWE Studies, collapse the timelines to align your study design elements with operational definitions, value sets and code lists, and export them all to help you move rapidly to RWD Assessment. Click here to get access to our learning resources. https://hubs.ly/Q02RtVXz0

Want to simultaneously create your operational definitions, value sets and code lists as you create your RWE Study protocols? RWE Sherpa can help you. Here is a taster of an overview given by our CEO Aaron Kamauu MD MS MPH on how RWE Sherpa can model your RWE Studies, collapse the timelines to align your study design elements with operational definitions, value sets and code lists, and export them all to help you move rapidly to RWD Assessment. Click here to get access to our learning resources. https://hubs.ly/Q02RD8c50

I attended a (really enjoyable) industry conference recently and have been reflecting on a couple of themes that emerged during the presentations & discussions. ? 'Real World Evidence' (RWE) is often claimed to be something that is not readily accepted by decision-makers in a cost-effectiveness analysis (CEA). This sentiment baffles me somewhat as RWE (i.e. observational evidence) is used extensively in almost every CEA (e.g. to inform resource utilisation rates, general population mortality, long-term OS and PFS and so on). I suspect some commentators may mean, specifically, that RWE is not so readily accepted as an evidence source for relative effectiveness. Such hesitance among decision-makers seems the height of reasonableness to me. An RCT is undoubtedly a more reliable basis for relative effectiveness estimates compared to RWE (e.g. as an external control arm) and it is important that decision-makers highlight this. In my experience, decision-makers do generally accept the realities of an evidence base even if relative effectiveness is ultimately based partially on RWE, but they quite rightly need to account for the (often significant) resultant uncertainty when making resource-allocation decisions. Relatedly, it is sometimes claimed that there is a reluctance among decision-makers to consider alternative pricing/payment models (IPMs) and that they just want to 'keep it simple' with price discounts. There may be truth in this, I can imagine for administrative reasons if nothing else. But the key point in my view is that whatever the mechanism for payment (and some of these IPMs indeed may help to address issues of uncertainty and upfront affordability), we still must, first and foremost, calculate an average cost per QALY gained and if this is not below a suitable threshold, then adopting the treatment would do more harm than good. There's nothing more simple than that.??

How are RWE integrate in the regulatory process? Learn more here!

Check out the article and fireside chat Matt Veatch had with David Thompson about his important survey highlighting whether the explosion in data and solutions is making is easier or harder to generate RWE. If you’re interested in connecting in Barcelona feel free to reach out. #ISPOReurope

Based on similar market feedback, we at Navidence agree with the insightful findings of David Thompson who queried over 50 anonymous researchers in the RWE space to rank their difficulties using secondary data sources to generate RWE. Do their experiences resonate with yours? Click the link below to read the full article in the latest edition of the ISPOR Value & Outcomes Spotlight publication. https://hubs.ly/Q02TqgMr0

From regulators to payers, more stakeholders are requesting immediate, relevant evidence to demonstrate product value. With increasing interest from regulators, developing #realworldevidence to communicate value of the product is not just a ‘good-to have’ anymore, it's a must! Join our upcoming webinar and listen to our expert as he takes you through the latest concepts on Health Economics and Outcomes Research (#HEOR) and Non-interventional Studies (NIS) and how to utilize the evidence to communicate value to payers and regulators. Register here: https://bit.ly/4al5gpM

Want to learn about IQVIA’s Real World Evidence (#RWE) training programs on pharmacoeconomic modelling, valuing health outcomes, HTA submissions, NIS planning and designing, and more? Join our upcoming webinar and listen to our expert as he takes you through the latest concepts on Health Economics and Outcomes Research (HEOR) and Non-interventional Studies (NIS) and how to utilize the evidence to communicate value to payers and regulators. Register here: https://bit.ly/4b1Bt6d

While recent real-world evidence (RWE) frameworks have extensively covered considerations for the assessment of fitness of data in RWE studies, why is there little to no consideration of methodological approaches to guide the transportability of RWE across regions? Join us for an exploration of this topic at an ISPOR short course scheduled for March 27-28. https://ow.ly/hav150QW4tO #RWE #RWD #HTA

It is essential to develop a well thought-out protocol in order to conduct a meaningful RWE study. Please read our introductory summary on RWE study protocol. #mdr #clinicalevidence #RWE