?? CoLab #2 EU HTA 2025, Biden Administration to Cover GLP-1 Agonists, Will Germany’s Hospital Reform Tank Patient Recruitment in Trials and More
?? Hey, there!
In times where every industry is interconnected, it’s important to understand the impact of global news on clinical research.?Here's what’s been on our radar:
?? 1. New year, new regulation: EU HTA launches January 2025?
?? On 12 January 2025, the EU Health Technology Assessment Regulation (EU HTA) takes effect, marking a significant shift for healthcare across Europe’s 27 Member States. This long-awaited reform centralizes health technology assessments (HTAs), promising faster, more equitable access to innovative treatments for nearly 450 million people.
?? What Does This Mean?
?Are You Ready For The New EU HTA Regulation?
Our team created an easy-to-listen audio summary. If you want to receive it let us know in the comment section ??
?? 2. Biden administration proposes GLP-1 agonists coverage: a public health turning point?
The Biden administration has proposed expanding Medicare and Medicaid coverage for GLP-1 agonists, potentially bringing these transformative drugs to 7.4 million more Americans by 2026. While promising, the initiative carries an estimated $36 billion price tag over 10 years, raising critical questions about cost, access, and long-term sustainability. With the new administration set to take over, the future of this proposal remains uncertain.
?? Are we witnessing a paradigm shift in public health?
By reframing obesity as a chronic condition rather than a lifestyle issue, the proposal could not only accelerate the decline in obesity rates but also ease the burden of diseases like diabetes and heart disease. The US National Health and Nutrition Examination Survey reports a 2% drop in obesity rates between 2020 and 2023, signaling potential progress
The US obesity rate fell in 2023, Source: FT Analysis of US National Health and Nutrition Examination Survey. FT graphic: John Burn-Murdoch /@jburnmurdoch
Meanwhile, in the UK, the NHS is exploring the broader societal impacts of GLP-1s, including their role in addressing unemployment.?
This rapid adoption of GLP-1s demonstrates the power of pharmaceutical innovation to tackle entrenched health challenges, but their social, financial, and political implications remain to be seen.
?? ????3. Germany’s €50 billion hospital reform and what it means for clinical trials
Germany has approved a €50 billion hospital reform to modernize infrastructure, enhance care quality, and address inefficiencies in its healthcare system.?
??? Key Highlights:
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The reform, set to roll out in 2025 aims to address inefficiencies, ensure sustainability, and create a more patient-focused healthcare system.
But what are the implications for clinical trials? Will the closing down of smaller hospitals reduce the number of potential trial sites patients can access? And how will centralization impact recruitment, given that one of the biggest obstacles to patient participation is travel distance to site? Share your predictions in a comment ??.
?? 4. Webinar You Can’t Miss
Navigating FDA’s Diversity Action Plan Draft Guidance: From Strategic Planning Through Study Success
??? December 4 | 10am EST / 3PM GMT (UK)
Learn how clinical trial sponsors and CROs can approach compliance with FDA’s guidance on developing and implementing diversity action plans.
?? 5. Looking for New Opportunities?
Check out these jobs in clinical research:
?? Specialist, Regulatory Affairs at Novo Nordisk
?? “Missing” clinical trial results and data transparency: where are we failing?
A recent article by TranspariMED highlights four key lessons from the growing issue of missing clinical trial results, which threatens the integrity of scientific research.
One of the most critical points highlighted is the mess that are clinical trial registries and the need for better, more meticulously structured data. It is the responsibility of the sponsoring institution to ensure that all reporting is complete, accurate and up to date.?
?? Metascience fail: Four lessons from inaccurate data on "missing" clinical trial results by Till Bruckner
?? PODCAST: More on data transparency in clinical research with Till Bruckner
?? Stay Tuned That’s it for this issue. Got any thoughts or questions? Drop them in a comment ??. Let’s discuss!
COO & Co-founder @ FindMeCure??find innovative treatments & TrialHub ??plan successful clinical trials
2 个月Germany moving (partially) from payment for procedures performed to fixed costs, makes sense for reducing unnecessary surgeries/procedures. Then again it begs the question of wether it's possible to have payments based on results, i.e. health outcomes and prevention, rather than cost base or work being done. Unfortunately, this is likely unrealistic. Let's see how this will unfold. On the other end of the spectrum, reimbursement of drugs that lower obesity will have a ripple effect. Even at this price tag, it would still result in 10x more savings for the healthcare systems, let alone lives saved and improved. Again, it begs the question can we *just* be more mindful of what we eat and how we live... Ofc. this is a generalization, I am not talking about the people with actual medical condition, but for those who feel victim to the environment or their own habits.
Let’s Bring Research Closer to Patients
2 个月I am very interested to see this reform in Germany and its impact on clinical trials. This is coming at a time when the entire Europe is rethinking HTA processes so kind of feels like a mini storm coming before getting to a great new process with more transparency and efficiency. I wonder what Leif Kuse Martin Krauss and Andreas Beust think about it?
?Are you ready for the upcoming EU HTA changes?Our team created an easy-to-listen podcast audio summary. Comment or react to this post if you want to have a listen.