Clinical Trials Arena’s Post

The recent £400m investment into clinical trial infrastructure in the UK is a game-changer for so many reasons. The investment is in line with the findings of the O'Shaughnessy review of commercial clinical trials published last year, which called for a doubling in trial recruitment by 2025 and another doubling by 2027. The ambitious initiative, led by the Department of Health and Social Care, NHS England, and The Association of the British Pharmaceutical Industry (ABPI) will establish up to 18 new Commercial Research Delivery Centres, enhancing the NHS's capacity to conduct cutting-edge research. This has enormous potential to: ➡️Increase opportunities for patients to participate in clinical trials, significantly improving health outcomes ➡️Speed up access to cutting-edge treatments, providing a lifeline to patients where no approved treatment options are available ➡️Bring research closer to communities, with trials conducted across various healthcare settings ➡️Increase access to the latest equipment and technology for researchers ➡️Improve efficiency and reduce waste and emissions, with sustainable manufacturing initiatives supported ➡️Boost economic growth and enhance the global competitiveness of the UK’s life sciences sector This investment represents a significant vote of confidence in our nation's ability to drive medical breakthroughs and ensure faster access to innovative treatments for patients. It’s a reminder that by strengthening our research capabilities, we're not just improving health outcomes—we're also fuelling economic growth and ensuring the NHS remains fit for the future. Read more: https://lnkd.in/etyECXyf    

🔍 #ClinicalTrialsDemystified 💉 Did you know? Every year, thousands of clinical trials worldwide are pivotal in advancing medical therapies! They're not just checkboxes; they're critical stages in drug development, offering invaluable insights into treatment effectiveness and safety. 💡 Curious about what goes into a clinical trial? Dive deeper into their indispensable role in healthcare innovation through this post and learn how they're paving the way for new treatments to reach those in need. #HealthcareInnovation #MedicalResearch 🌟

DEMYSTIFYING CLINICAL TRIALS ▸ Every year, thousands of clinical trials across the globe play an essential role in advancing our understanding of medical therapies. These trials are not merely regulatory requirements; they are crucial phases in the lifecycle of drug development, providing key insights into the efficacy and safety of prospective treatments. 💡But what's actually involved with a clinical trial? Discover more below about the vital role of clinical trials in healthcare innovation and how they pave the way for new treatments to reach those in need. The article explores questions and topics like: 🌐 What is a clinical trial? 🎯 Why are clinical trials important? 🌍 The global landscape of clinical trials and key areas of focus 🔄 The phases of clinical trials 🔗 The future of clinical trials including the impact of technology #ClinicalTrials #MedicalResearch #PatientCare #Innovation #Healthcare #Akesa #ClinicalTrialSupplies

It’s important patients, clinicians and government scrutinise potential unintended outcomes of some HTA review options paper proposals that could have long term consequences for patients.   One of these is the proposed requirement for cost minimisation submissions to include a lower price or incentivise offers for lower pricing.   This will stymie patient choice and disincentivise innovation.    When a pharmaceutical company develops a new medicine with similar health outcomes to an existing PBS medicine, the company can apply to list the medicine on the PBS through a cost-minimisation pathway. This means that the new medicine with similar outcomes is usually given the same price as the existing medicine.   Cost-minimisation can speed up patient access.   Applications using this pathway sometimes involve medicines with an advantage for patients compared with existing medicines. For example, a tablet taken at home instead of an intravenous drip that requires a hospital visit, or a medicine that can be taken once a day instead of three times a day, is better for patients. The research and development that goes into creating these kinds of improvements must not be devalued.   Choice in medicines can make a huge difference to patients, their quality of life and ability to participate more actively in society.   Industry has called on the Government to introduce streamlined pathways to reduce time to access for patients who need alternative options. This reform cannot include stipulations that will erode patient choice and innovation.  

Clinical Trials Market worth $73.2 billion by 2028 | CAGR of 8.7% 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐏𝐃𝐅 𝐁𝐫𝐨𝐜𝐡𝐮𝐫𝐞: https://lnkd.in/diDeUV6P The global #clinicaltrials market is projected to reach USD 73.2 billion by 2028 from USD 48.2 billion in 2023, at a CAGR of 8.7% during the forecast period of 2023 to 2028. #clinicaltrialsinnovation Clinical Trials Transformation Initiative (CTTI) Clinical Trials of Texas, A Flourish Research Site        The Clinical Trials Network, (CTNx)        Clinical Trials Ontario        Clinical Trials Arena        The Clinical Trials Guru, LLC        Clinical Trials Innovation Programme (CTIP)        Clinical Trials Team        Clinical Trials BC        Clinical Trials of South Carolina        Clinical Trials Centre, The University of Hong Kong        Clinical Trials Series        Clinical Trials Symposium        Clinical Trials Resource Group, LLC        Clinical Trials Management GmbH        Clinical Trials Research        Clinical Trials For All        Clinical Trials Packing Services        Worldwide Clinical Trials        Applied Clinical Trials Magazine       

Inato has published a study that looks at the process of selecting sites for clinical trials, and examines the relationship between the sponsor and the sites. Admittedly Inato has a vested interest in progressing change in this space, but the issues highlighted were widespread and commonplace. At a high level, there is distrust between the two groups. Sponsors talk of issues around selection timescales, and sites failing to live up to their stated capabilities, leading to sites failing to recruit patients and carry out the detailed protocols to meet the time expectations of the sponsors. Sites talk of issues of overly rigid questionnaires that fail to allow the site to communicate their abilities, and essentially manual processes that don't allow them to leverage resources they have produced in the past. Sites also talk about lack of information being shared about the detailed protocols required, and expectations on patient enrolment. The article interviews Liz Beatty, co-founder and chief strategy officer at Inato. She suggests numerous improvements that could be made that she believes would ultimately result in faster, more competitive and inclusive clinical trials. https://lnkd.in/enK5nTqD #clinicaltrials #clinicalresearch #clinicaltrialmanagement

Brief importance of Clinical Trials ⬇️ Clinical trials are crucial for advancing medical knowledge and improving patient care. They systematically test the safety and efficacy of new treatments, drugs, and medical devices before they become widely available. Through rigorous methodologies, clinical trials help identify the benefits and potential risks associated with new interventions. One of the key importance of clinical trials is ensuring patient safety. By following strict regulatory standards and ethical guidelines, clinical trials minimize risks to participants and help identify adverse effects early. This process protects the public from ineffective or harmful treatments. Clinical trials also provide high-quality evidence for medical practice. They help healthcare providers make informed decisions based on proven data, leading to better patient outcomes. Furthermore, clinical trials support regulatory approvals, ensuring that only safe and effective treatments reach the market. In addition, clinical trials contribute to scientific knowledge by uncovering new insights into diseases and their treatments. This knowledge can lead to the development of better therapies and innovative approaches to healthcare. Overall, clinical trials are indispensable for the progress of medicine, enhancing patient safety, guiding clinical practice, and advancing scientific understanding. #Clinicaltrials

⚡️NEW Blog | Rescue Studies⚡️ Have a study that's facing unexpected roadblocks? Clinical trials are vital for medical advancements, but even the most meticulously planned studies can steer off course. From resource shortages and recruitment issues to adverse events and early analysis indications that it may not demonstrate required drug efficacy - these challenges can bring even the most carefully planned trials to a grinding halt ⏱️ But there's hope! These challenges don’t have to signify the end of the road, a rescue study if executed promptly to address a trials specific needs can be the intervention required to ensure your research is resilient against unexpected setbacks moving forward, to get your study back on track and set up for success. Click below to read our new article and deep dive into rescue studies, the challenges, the additional regulatory hurdles, and how to plan to ensure efficient execution 👇 https://hubs.li/Q02pvYnL0 #ClinicalTrials #Research #RescueStudy #Healthcare #RescueStudiesinClinicalTrials #BiometricCRO

Ultimate goal is access to appropriate patient populations to improve treatment and outcomes. Employing a multi-pronged hybrid approach during this transitional period is crucial to service pharma, CRO's and patients appropriately...There is no doubt community-based trials will increase in the future for the right therapeutic areas and geographies...

Congratulations to Praxis Precision Medicines and to Marcio Souza on this innovative Ph 3 clinical trial. There are some key learnings here: Not all clinical trials require patients to visit a site for every visit and patients prefer to be at home. Ultimately this will help sponsors recruit (3-5x in this study) and retain patients in their global trials. The recent flood of FDA published Guidance around DCT, Diversity and DHT demonstrates encouragement and tailwinds for sponsors and is fuel to think differently about how they use technology to move clinical trials forward. We consistently and significantly underestimate the comfort level older people have with technology. Efficiencies are a win-win for patients and drug/device developers. #DCT #clinicaltrials AliveCor Praxis Precision Medicines, Inc. Marcio Souza