Advarra’s Post

Enhance trial planning and success! Understand the evidence generated in your areas of interest, pinpoint optimal trial locations, and gain insights on ongoing trials. Stay ahead with IQVIA Trial Link. Request a demo today! #ClinicalTrials #ResearchAndDevelopment https://bit.ly/3yqGQ0H #IQVIATrialLink #ClinicalTrialLocations

I was so honored to speak at #DIA2024 today as part of the panel “Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-making.“ A big thank you to Steffen Thirstrup and Robyn Bent for organizing and leading the discussion and to Dr Solange Corriol-Rohou, MD, Juan Garcia Burgos, and Maria Apostolaros for fantastic insights and lessons learned. Some of the key take-away for me : - we have come such a long way in patient engagement and patient experience data, in particular for #rarediseases; yet, we have a long way to go. - patient experience data means a lot of different things to a lot of different people, and that diversity of use cases is great, but it can also be really confusing! - patient experience data must be fit for purpose. What that looks like is not always clear though. Standardization through efforts at FDA, European Medicines Agency, and through international bodies like #ICH is really important, and we need to get these guidance documents right. - we now have a LOT of success stories where patient experience data informed study design, endpoint selection, recruitment strategies, informed consent and assent, benefit-risk-consideration, labeling, and so much more. We need to capture these wins and the best practices and approaches that led to success. We also need metrics, measurement, and better transparency in how patient experience data is used to inform #drugdevelopment and #regulatorydecisionmaking - despite all the progress most #raredisease #PFDD meetings and listening sessions still occur too late in the drug development process; we need to disbunk assumptions that these meetings require high production and costly consultants; - we need to talk about the resources and tools needed to support patient experience data collection - for sponsors as well as FDA and patient groups! -we need public-private partnerships and a long view, changing minds and practices will not happen overnight. And we need to keep showing the impact and ROI! What a great discussion! Thank you for including the National Organization for Rare Disorders in this discussion!

Please check out this informative article on Clinical Trial Design written by my colleague Sugato De.

In this video clip, Nick (Domenico) Palumbo of Takeda explains that with feasibility in clinical trials, it has to be a “two-way street” between the sponsor and sites. He and Mireille Ermens (Mimi Ermens) of CSL talk about the types of questions that need to be asked and the kinds of data that need to be shared by each stakeholder. https://lnkd.in/gn78u2dy #clinicaltrialfeasibility #clinicaltrials #clinops

When it comes to clinical trials, Patients Can't Wait. That’s why LabConnect's team of technical and scientific experts quickly coordinate all laboratory-related needs to accelerate the development of new medicines across a wide range of therapeutic areas. Get the ⭐ Top Takeaways from our webinars ⭐ on how we are addressing key clinical trial challenges.  = > https://bit.ly/3tcdErC Learn more and explore how we can partner together to accelerate the development of new medicines. #LabConnect #LivesDependOnIt #ClinicalTrials 

As I said in this article, I firmly believe that adaptive trials hold the potential to dramatically increase the efficiency and effectiveness of drug development. Along these lines, adaptive enrichment can be a cornerstone in the precision medicine transformation! #clinicaltrialdesign #drugdevelopment #regulatoryapproval #adaptivedesign #clinicalresearch #healthcareinnovation #drugapproval PhaseV | Meri Beckwith | Lindus Health | Jytte van Huijstee | myTomorrows

Implementing efficient #randomisation adaptations in master protocols is one of Almac’s many solutions for increasing flexibility and efficiency in your clinical trial. What to know more about Almac's randomisation capabilities? Check out this latest whitepaper! https://okt.to/UhkwoX #clinicaltrials #drugdevelopment

In this upcoming webinar, discover several alternative clinical supply models available today. Catalent experts will also help attendees identify key considerations when planning to adopt these models in their trials. Register today! https://ow.ly/iHVZ50Rfnq0

With a growing focus on learning how diverse patients respond to treatments administered outside of the clinical trial setting, #RWE is recognized as a supplement to traditional RCTs. Read more about the considerations – including how RWE can be used to fill evidence gaps for clinical, regulatory, and payer decision-making. https://bit.ly/3R8bCSi

If you’re heading to DIA 2024, don’t miss IQVIA’s Barbara Arone and WEP Clinical’s Ana Tediosi as they discuss the complexities of Pre-Approval Access (PAA). Focusing on key decisions and success factors, this session will highlight pragmatic decisions that play into the development of efficient Pre-Approval Access programs, and address considerations and challenges for the provision of investigational products to patients outside of clinical trials. https://bit.ly/3yCE5cd #DIA2024