Mel Walker’s Post

Q: Why are Clinical Trial Enrollment timelines increasing across all TAs? A MUST READ for ClinOps Directors currently planning Global Clinical Trials The Clinical Research ecosystem has undergone significant evolution over the past five years due to technological, environmental, societal, regulatory, and geopolitical shifts. These changes have reshaped clinical trial activities and operations, bringing both opportunities and challenges. "Rethinking Clinical Trial Country Prioritization"📊 Our latest IQVIA Institute for Human Data Science report (source: https://lnkd.in/ea_9WeSA) explores: ✅ The emergence of new global players in clinical trials. ✅ Execution challenges, delays, capacity concerns, and uncertainties impacting clinical development timelines and patient outcomes. ✅ The critical focus on global diversification of clinical trials. ✅ Trends in enrollment timelines, trial characteristics, and country utilization. ✅ Exploration of countries with high patient recruitment potential. Authors: Murray Aitken and Nicole Connelly IQVIA accelerating innovation for a healthier world 🌍 #ClinicalTrials #GlobalHealth #HealthEquity

Xcene Research is on a mission to deliver top-tier data quality, advancing healthcare in Africa. Our commitment to precision, trust, and unwavering dedication sets us apart. Discover how we ensure exceptional results in clinical trials in our new blog post. Feel free to click the link below for an enjoyable read. https://lnkd.in/dgHyapSC #ClinicalResearch #xceneresearch #clinicaltrials #DataQuality #HealthcareForAfrica"

The attached two pages-long editorial is a nice summary for all colleagues that want to learn more on the use of #RWE. As the authors pointing out, RWE should be seen as supplementary evidence enhancing clinical trials. The authors use examples from #Ophthalmology, but the messages are applicable across TAs. There are (at least) eight cases that RWE could support pre- and post-launch activities: 1. Quantify unmet need, landscaping and prevalence of the disease, to understand market size. 2. Calibrate clinical trials inclusion and exclusion criteria in terms of expected recruitment rate and generalizability of the results. 3. Ensure that trial population follows the racial and ethnic distribution seen in real life. 4. Identify clinical sites rich in the targeted trial population. 5. Use real data to create external control arms for single arm studies. 6. Characterize the safety profile of products that have been launched in the market. 7. Understand the benefit in subpopulations of interest that are underrepresented in clinical programs, with the potential of label expansion. 8. Explore barriers to care seen in daily clinical practice that might impact clinical outcomes (like low adherence, proximity to sites, etc). The authors conclude that use of RWE can accelerate development of promising assets and make them earlier available to patients. Disclaimer: The opinions shared are solely my own and do not express the views or opinions of any of my employers.

While randomized controlled trials (RCTs) have traditionally been considered the gold standard for demonstrating efficacy and safety, it is worth noting that there has been a significant global increase in the inclusion of Real-World Evidence (RWE) in submissions for Health Technology Assessments (HTAs). In this study, which was published today and forms part of my doctoral research, our objectives were as follows: a) To evaluate the current utilization of Real-World Data (RWD) and RWE in the HTA, b) to systematically analyze the barriers, challenges and potential opportunities associated with their inclusion in the HTA process, c) to synthesize the perspectives of several stakeholders across countries regarding the inclusion of RWD and RWE in the HTA process. We hope that these findings can offer valuable guidance to policy-makers and various stakeholders. For those interested, the full-text of the study can be accessed here:

🌐 Insightful Report Alert! 🌐 Title: Rethinking Clinical Trial Country Prioritization Key Insights: In this latest report by the IQVIA Institute for Human Data Science, we explore innovative strategies for selecting optimal countries in clinical trials. The analysis considers real-world data, patient availability, regulatory environments, and healthcare infrastructure, to name a few. Clinical trials drive medical progress. This report equips us with evidence-based insights to make informed decisions. Let’s stay ahead in the race to improve patient outcomes! Get your copy of the report: https://lnkd.in/erWtB-qG

Do you have a clear picture of the UK market access landscape and the routes to market for your innovation? If not, we can help you understand the nuances of the NHS and map out the key stakeholders that you need to engage with. In this case study, our diagnostics client was looking to identify and explore current and future opportunities, as well as routes to market within the NHS. We conducted targeted desk research of NHS, market access, and regulatory policy, as well as best practice examples, before developing a stakeholder map. We then used our network of NHS Associates to validate our findings and gain further first-hand insights into current practice and opportunities for diagnostics within the NHS. The client then gave us this feedback: “The UK Diagnostic Landscape Study has proved to be really good value for money – we’re really pleased. The report has provided our UK team with a lot more detail than we had before, and we are taking learnings forward to apply to our European strategy.��� – Market Access and HEOR Director, Diagnostics and Medical Device company Read the full case study at https://lnkd.in/e4GxVc-d If you're looking for help in this area, email info@mtechaccess.co.uk today to speak to our team. #stakeholdermapping #NHSinsights #marketaccess #marketresearch #diagnostics #Pharma #medicaldevices #Medtech

BCG and BCG X recently conducted a #machinelearning analysis of over 16,000 clinical trials to reveal a fascinating parallel: Trial innovation is increasing, but so is complexity—introducing new challenges related to cost, duration, and success rates for patients and providers. Be sure to check out our new research and findings in Nature Scientific Reports: https://bit.ly/3uyEz1i #HealthCare #ClinicalTrials

BCG and BCG X recently conducted a #machinelearning analysis of over 16,000 clinical trials to reveal a fascinating parallel: Trial innovation is increasing, but so is complexity—introducing new challenges related to cost, duration, and success rates for patients and providers. Be sure to check out our new research and findings in Nature Scientific Reports: https://bit.ly/3uyEz1i #HealthCare #ClinicalTrials

BCG and BCG X recently conducted a #machinelearning analysis of over 16,000 clinical trials to reveal a fascinating parallel: Trial innovation is increasing, but so is complexity—introducing new challenges related to cost, duration, and success rates for patients and providers. Be sure to check out our new research and findings in Nature Scientific Reports: https://bit.ly/3uyEz1i #HealthCare #ClinicalTrials