The Evidence Base®’s Post

Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. by Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://lnkd.in/dMTE_tis Paper Url: https://lnkd.in/dvFjUS7C

🚀 Insights from Akrivia Health's Tina Marshall on RWE in Clinical Trials! 🧑💼 Had an enlightening conversation with Tina Marshall at Akrivia Health. Here are some key takeaways: 📊 RWE Revolutionizing Clinical Trials: Understanding patient characterization and disease burden is crucial. Tina emphasizes the role of unstructured NHS clinical trials data in the UK. 🤖 Innovative Solutions with Akrivia Synapse™: Their AI-driven tool is a game-changer, extracting vital information from a vast volume of free text in patient records. 🔍 Patient Journey & Drug Development: Tina highlights how longitudinal NHS data aids in developing disease-modifying medications, stressing the UK's unique position in global healthcare. 🌍 Collaboration for Better Outcomes: The potential of RWE is immense, and collaboration across stakeholders can lead to targeted product profiles and more effective clinical trials. 🔬 The Future of RWE in Regulatory Decision-Making: Positive shifts in regulatory attitudes towards RWE signal a bright future for clinical research, especially in the UK. 🇬🇧 The UK: A Life Sciences Powerhouse: With its diverse population and digitally mature healthcare environment, the UK is poised to be a key player in clinical trials. Stay tuned for more insights on how RWE is shaping the future of healthcare! #ClinicalTrials #RealWorldEvidence #HealthcareInnovation #AkriviaHealth #UKHealthcare

Our latest blog post explores the indispensable role of Health Economics and Outcomes Research (HEOR) consultancies in guiding pharmaceutical, biotechnology, and medical device companies through the intricate processes of product development, regulatory approval, and market access. As the healthcare industry evolves to become more outcomes-focused and cost-conscious, HEOR consultancies are more critical than ever. Highlights from the Post: - Strategic Development: From the early stages of product development, HEOR consultancies integrate economic and clinical data to build compelling value propositions that resonate with regulators and payers. - Evidence Generation: HEOR experts employ sophisticated methodologies to demonstrate the economic and health benefits of new technologies, supporting key decisions from pricing strategies to reimbursement negotiations. - Stakeholder Engagement: Effective communication with stakeholders, including payers, healthcare providers, and patient groups, is facilitated to align product benefits with market needs and expectations. Learn how HEOR consultancies not only support compliance and facilitate market access but also ensure that new healthcare innovations deliver real value, improving patient outcomes and enhancing system efficiencies. Dive into the full article for a comprehensive look at how HEOR consultancies drive success in the dynamic landscape of global healthcare. https://lnkd.in/eNXDqzQE #HEOR #reimbursement #costeffectiveness #pharmaceuticals #HTA #marketacces #HealthEconomics 

"You almost can’t start early enough when looking at how to optimise patient access for innovative medicines. In the specialised, personalised, and advanced medicines spaces, this work should start very early — as early as Phase I or Phase II of clinical development." - Dr. Heather McDonald, AstraZeneca This profound insight from Dr. McDonald resonates deeply with our experiences at GENerX Life. In our conversations with clients, we consistently emphasise the critical importance of early-stage planning in HEOR and market access strategies. The journey of bringing groundbreaking therapies from the lab to the market is intricate and multifaceted. In this rapidly evolving landscape, establishing robust HEOR and market access frameworks is not just an end-stage consideration but a foundational step that should parallel clinical development. At GENerX, we are at the forefront of this paradigm shift. We partner with life sciences companies to build and integrate high-caliber HEOR and market access teams right from the early phases of clinical development. Our approach ensures that innovative treatments are not just clinically effective but also economically viable and accessible to those who need them the most. Dr. Heather McDonald's interview with additional insights can be found here: https://lnkd.in/et6w3YYM. It's a compelling read for anyone involved in the journey of transformative healthcare solutions. #HEOR #MarketAccess #LifeSciences #ClinicalDevelopment #PatientAccess #InnovativeMedicines #HealthcareSolutions

- Unlocking the Value of HEOR in Healthcare Innovation - Discover the crucial role of Health Economics and Outcomes Research (HEOR) in our latest blog post. HEOR is pivotal for guiding pharmaceutical, biotechnology, and medical device companies from product development to market access. It evaluates the economic impact and patient outcomes, ensuring products not only meet regulatory standards but also gain payer acceptance and fit into clinical guidelines. Learn how HEOR, through cost-effectiveness analysis and real-world evidence, supports robust pricing strategies and helps products perform effectively in real clinical settings. Dive deeper into how HEOR is shaping sustainable healthcare solutions by reading the full article on our website. https://lnkd.in/eU_mVeWa #HEOR #reimbursement #costeffectiveness #pharmaceuticals #HTA #marketacces #HealthEconomics 

Real-world evidence (RWE) continues to command the spotlight in Health Economics and Outcomes Research (HEOR) as highlighted in the recent ISPOR trend reports. This reflects RWE's critical role in transforming healthcare decision-making, by providing insights that are not attainable through traditional randomized controlled trials (RCTs) alone. RWE studies offer a comprehensive view of patient outcomes in real-world settings, capturing data from a broad and diverse patient population. This inclusivity and the speed at which RWE studies can be conducted present a pragmatic alternative for evaluating the safety and effectiveness of healthcare products. As the healthcare industry seeks more inclusive and efficient evidence-generation methods, RWE stands out for its ability to deliver timely and relevant insights. The significance of RWE is further underscored by the evolving regulatory landscape. Key healthcare agencies, including the FDA, EMA, NICE, and CADTH, have recently provided guidance on RWE generation and use, focusing on aspects such as data quality, fit-for-purpose use, and methodologies supporting reliable causal inference. A landmark example of RWE's regulatory impact is its use in 2021 for a new indication of tacrolimus in lung transplant rejection prevention in the United States. This case marked the first instance of RWE serving as primary evidence of efficacy, highlighting RWE's potential to support new indications and therapies based on real-world data. The future RWE in HEOR is marked by its pivotal role in enhancing drug approval processes, supporting the shift towards value-based healthcare, personalizing patient care, and informing health policy and clinical guidelines. As technological and analytical capabilities advance, RWE will increasingly inform and improve healthcare quality, efficiency, and outcomes, ensuring that healthcare decisions are grounded in comprehensive and real-world patient experiences.   #HEOR #reimbursement #costeffectiveness #pharmaceuticals #HTA #marketaccess #RealWorldEvidence #HealthcareDecisionMaking #PatientOutcomes #ISPOR #EvidenceBasedHealthcare ISPOR—The Professional Society for Health Economics and Outcomes Research You can read the full ISPOR 2024-2025 Top 10 HEOR Trends Report here: https://lnkd.in/dPGqxZU

Read our blog about a conversation with Kristijan Kahler, executive director of innovation evidence at Novartis, that explored the value of synchronizing a clinical trial subject to real-world data (RWD). Clinical trials, as traditionally designed, have limitations and pose challenges that RWD can solve. Read our blog to learn more. https://hubs.ly/Q02k8rlV0

Check out our conversation with Kristijan Kahler, executive director of innovation evidence at Novartis, on the value of synchronizing a clinical trial subject to real-world data (RWD) and learn his views on how RWD can address the limitations and challenges posed by traditional clinical trials https://hubs.ly/Q02lDbw-0

Traditional clinical research can be slow and complex. Real-world evidence (RWE) has brought a fresh perspective, but its full potential remains untapped. Only 1% of Phase IV trials use RWE, and around 3% focus on drug-specific data. Enter Prospective Real-World Studies (PrwS), a game-changer. 🔷 What Are PrwS? - PrwS intentionally collect new, comprehensive data on top of existing real-world data (RWD). This includes detailed outcomes, patient-reported data, and more. They seamlessly fit into routine clinical practice, requiring minimal additional technology or training. 🔷 The Benefits - PrwS can revolutionize clinical research. For example, the Prospective Clinico-Genomic (PCG) Study achieved remarkable success in patient enrollment, addressing selection bias. 🔷 The Promise Ahead - PrwS studies offer biopharma companies a significant opportunity. By incorporating prospective real-world data, they can execute post-marketing studies efficiently and enhance RCT control arms at a fraction of the cost without compromising data quality. With investments in technology and infrastructure, PrwS studies are poised to reshape clinical research. #ClinicalResearch #RealWorldEvidence #ProspectiveStudies #HealthcareInnovation #Biopharma

𝑰𝒏𝒅𝒖𝒔𝒕𝒓𝒚 𝑩𝒍𝒐𝒈 In the expansive shade of healthcare, Unmet Medical Needs form intricate knots, representing challenges awaiting resolution. These needs span a wide spectrum, from the intricacies of rare diseases, affecting only a small fraction of the population, to the pervasive impact of widespread ailments lacking efficacious treatments. 𝐑𝐞𝐚𝐝 𝐅𝐮𝐥𝐥 𝐁𝐥𝐨𝐠: https://bit.ly/3XaJmBS 𝐄𝐦𝐚𝐢𝐥 𝐮𝐬 𝐚𝐭: [email protected] #drugdiscovery #leadership #drugdiscovery #innovation #genomics #sciencestudent #steam #scientist #biologics #medicinalchem #drugdiscovery #oncology #bioinformatics #genomics #innovation #toxicology #structuralbiology #licensing #drugdiscoveryconference #ddip #ddipeu #worldbievents #scienceresearch #ddip24