Maurizio Scarpa’s Post

There is increasing momentum behind the Joint Clinical Assessment before it is implemented next January in the European Union. Read the latest updates and what the JCA could mean for patients in member states at https://hubs.li/Q02n2h3v0 #PatientsFirst #EMA #PatientAccess #MarketAccess

**The Future of Clinical Trials in the EU: ACT EU Initiative Gets Underway** Exciting news for clinical research in Europe! The Accelerating Clinical Trials in the EU (ACT EU) initiative has officially launched its multi-stakeholder platform (MSP) designed to revolutionize the clinical trial landscape across the EU. What is ACT EU? This collaborative effort between the EMA, Heads of Medicines Agencies (HMA), and the European Commission (EC) aims to streamline and enhance every aspect of clinical trials in the EU. This includes everything from initiation and design to conducting and running the trials themselves. Why is the ACT EU MSP Important? As highlighted by María Jesús Lamas, co-chair of the MSP advisory group, this platform fosters crucial collaboration among various stakeholders. This open dialogue will address challenges and leverage opportunities arising from advancements in clinical trial regulations, methodologies, and technology. Ultimately, this benefits EU citizens by ensuring access to innovative medical research. My Take on ACT EU and the EU Clinical Trial Regulation (CTR): The ACT EU initiative aligns perfectly with the goals of the EU CTR (Regulation (EU) No 536/2014), which came into effect in 2016. The CTR emphasizes patient safety, transparency, and efficiency in clinical trials. The ACT EU MSP will likely focus on these areas as well, leading to: More Efficient Trials: Streamlined processes can expedite trial approvals and participant recruitment. Enhanced Patient Engagement: The platform can explore ways to better inform and involve patients in the research process. Improved Transparency: Increased data sharing and public access to trial results can foster trust and scientific progress. In summary, the ACT EU MSP is a significant step towards a more robust and efficient clinical trial environment in the EU. This will undoubtedly benefit patients, researchers, and the development of life-saving medicines. Source: https://lnkd.in/dPxAaV7U

🔔 Exciting Update from the FDA! 🔔 We are proud to support and champion the FDA's latest draft guidance on Diversity Action Plans in clinical trials. At Medovation Clinical Research, we believe that inclusivity is essential for innovation in healthcare. 🌟 Why is this important? The new FDA draft guidance outlines crucial steps to ensure diverse participation in clinical trials, enabling better representation of all communities in the development of groundbreaking treatments and therapies. This is a significant step forward in making healthcare advancements accessible to everyone, regardless of their background. Our Commitment to Diversity: Partnering with Community-Based Physicians: We work closely with community-based physicians who understand and serve diverse patient populations. Enhancing Access:  Our efforts are focused on bridging gaps and ensuring that ALL patients have the opportunity to participate in clinical research, gaining access to novel treatments. Supporting Sponsors and CROs: We bring together community-based healthcare providers and Sponsors/CROs to foster a collaborative environment for inclusive research. Together with our partners, we are dedicated to creating a more inclusive and equitable future in clinical research. 📢 Learn more about the FDA's new draft guidelines here. #DiversityInResearch #ClinicalTrials #InclusiveHealthcare #MedovationClinicalResearch

Integrating RCTs into Routine Clinical Practice This draft guidance from the FDA aims to streamline the integration of randomized controlled trials (RCTs) into routine clinical practice. The core idea is to make clinical trials more accessible and integrated with real-world settings, similar to how decentralized clinical trials (DCTs) work by enabling trial-related activities in more convenient locations, such as patients’ homes. Key aspects include: 1. Streamlined Protocols: The guidance promotes simplified protocols and essential data collection to reduce the burden on participants and speed up trial timelines. 2. Engagement of Local Health Care Providers (HCPs): Local HCPs can be engaged in specific tasks such as collecting routine data (e.g., vital signs) and performing basic medical procedures without requiring trial-specific training. 3. Real-World Data (RWD): There’s an increasing reliance on RWD from routine clinical visits and electronic health records (EHRs) to support drug development and post-approval monitoring. This can enhance trial efficiency by utilizing already-existing clinical data. 4. Quality by Design (QbD) Approach: The guidance encourages employing a QbD framework to ensure trial reliability and patient safety. This includes designing trials that integrate naturally into clinical practice and align with the routine visits patients already undertake. 5. Simplified Eligibility and Data Collection: For trials integrated into practice, eligibility criteria and data collection should align with the routine clinical care processes, helping to reduce trial costs and improve participant engagement. 6. Blinding and Randomization: These remain critical to trial integrity, though they can add complexity. When blinding isn't feasible, measures should be implemented to control bias. 7. Safety Monitoring and Adverse Events: Continuous monitoring of patients' electronic health records (EHRs) or follow-up calls by trial personnel can help track adverse events, especially serious ones, without the need for dedicated trial sites. Comments for Pharma Leaders: This guidance aligns with the direction many of us are already heading in decentralized trials, making clinical research more adaptable to everyday clinical settings. By incorporating elements such as local healthcare provider involvement and leveraging real-world data, we are looking at faster trial enrollment and broader participation from a more diverse population, which ultimately increases the generalizability of our results. https://lnkd.in/eEQ4eMwt

📢 News: Australia’s Clinical Trials Sector More Valuable Than Ever Before Figures from a new MTPConnect report reveal that the clinical trials sector generated $1.6 billion for the Australian economy in 2022. The outcome, detailed in MTPConnect’s upcoming clinical trials sector snapshot report, represents growth of more than 4 per cent on 2019 and has been achieved in spite of the 2020 pandemic downturn. MTPConnect CEO, Stuart Dignam, says it’s an outcome worth recognising as we celebrate World Clinical Trials Day this week. Australia’s clinical trials capabilities and expertise will be a key focus for the Australian delegation heading to the BIO International Convention in San Diego early next month. The full report, Australia’s Clinical Trials Sector 2024, will be released next week. 💻 Read on for more information... Stuart Dignam | Hon. Jaala Pulford | David Lloyd | Department of Industry, Science and Resources | Ed Husic MP | Mark Butler MP | Australian Government Department of Health and Aged Care | Australian Trade and Investment Commission (Austrade) | David Chuter | ARCS Australia | David Wilks | Ana Svensson | Kylie Sproston FTSE GAICD | Melanie Gentgall | Steve Webb | Janelle Bowden | Duncan Macinnis | Jo Close | Tracey Wilkinson | Lisa Dubé

With International Clinical Trials Day just passed, it’s great to be able to celebrate the value of clinical trials to the Australian economy and Australian patients. Looking forward to the full report! #Australia #clinicaltrials #value #hope #whyclinicaltrialsmatter #clinicaltrialsday

Having just celebrated #InternationalClinicalTrialsDay it is timely to share an upcoming #clinicaltrials report from MTPConnect, that reveals the clinical trials sector in #Australia is more valuable than ever. The sector generated $1.6B for the Aussie economy in 2022, representing more than 4% growth on 2019. Importantly, a vibrant and growing clinical trials sector translates to increased opportunities for innovative new treatment options and clinical approaches for our Australian patients! We're looking forward to sharing the findings from the full report, soon to be released. #clinicaltrials #economy #healthcareoutcomes #patientoutcomes #opportunity #clinicalresearch #clinicaltrialssector #medicalresearch #innovation

I disagree with the premise that “patient centricity” is the key for clinical trial optimisation. Clinical trials involve multiple stakeholder groups, each with their own objectives and interests. Like any system, optimum performance depends on alignment and interaction between parties. Focusing on any one party as the central focus, may seem beneficial at first glance, but is ultimately self limiting. Why grease only one cog? A more powerful approach is stakeholder collaboration and alignment around three guiding principles: A shared objective: Regardless which area of the clinical trial process we operate, we all need to take accountability for promoting and affirming the fact that our shared objective is to advance human health. We all have unique roles to play with their own challenges; however we need to remember we are all part of a big team pulling and pushing in the same direction. Of course this is also true patient centricity. Innovation and Flexibility: The clinical trial landscape is constantly evolving. A commitment to exploring innovative approaches, and new ways of doing things, is critical to our success. I don’t just mean focusing on the latest trends like adaptive trial designs, DCT or AI. Instead adopting and fundamental commitment to doing the simple things in a better way. This means continuously seeking out efficiencies, streamlining processes, and eliminating unnecessary burdens for all stakeholders. By constantly questioning the status quo and embracing a culture of continuous improvement, we can optimise the entire clinical trial process. Transparency and Trust: Open communication and clear expectations throughout the trial process build trust and foster a collaborative environment. Regular updates, transparent reporting of progress and challenges, and ensuring all stakeholders are informed and involved in decision-making processes are crucial. Transparency helps mitigate misunderstandings, aligns everyone’s efforts toward the common goal, and creates a sense of shared responsibility and trust among all parties. If we all commit to focusing on these three principles it will allow us to make real, sustainable progress…together. Outsourcing in Clinical Trials Event Series #clinicaltrials #health #clinicalresearch #biotech

“Expect delays!” It’s bad enough if you’re driving on a busy motorway, but what about the effect on clinical trials? Potentially millions of dollars/euros/pounds in lost revenue and more importantly patients not getting access to life-saving medicines. Clinical trial delays are bad news. But there are some things you can action, and this article, co-written by our Business Development Director Ian Hoban and GlobalData provides some useful tips. Click here https://bit.ly/3xtBIs6

Are you looking for the right CRO to run your early phase clinical trials? Read our latest blog on the benefits of working with smaller sized Clinical Research Organisations Ask us how we can help https://lnkd.in/dWnXvADq