National Organization for Rare Disorders’ Post

⚡Last Thursday, we held a regular meeting of the Clinical Trials Subcommittee. We discussed with the community the results of the Subcommittee's work for the first half of the year, the status of current projects, and further actions to improve the conditions for conducting clinical trials in Ukraine. 🙌Sincerely grateful to the CTS Board and all representatives of the EBA Clinical Trials Subcommittee member companies for their active participation in the Subcommittee's activities. #clinicaltrials #clinicalresearch #CTS #EBA #ClinicalTrialsSubcommittee

The NHS and our wider health system, supported by NIHR, have done an incredible job to achieve this progress. While strong recruitment is a sign of recovery since the pandemic, it’s just one facet of a healthy and thriving clinical research system. The needs of UK citizens and our health research system are broad and diverse. We are committed to maintaining a rich and balanced portfolio to best address patient and system needs across the UK, with: 💷 Commercial and non-commercial studies 🕙 Early and late phase studies 🩺 Studies focusing on rare and common diseases 🎯 Range of complex, intensive studies in small, highly targeted populations to pragmatic population health research in large cohorts 💡 Variety of methodologies and methods as appropriate to the research questions A well-rounded clinical research system is a healthy clinical research system.

Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) is excited to share a publication titled ""𝗙𝗶𝗿𝘀𝘁, 𝗱𝗼 𝗻𝗼 𝗵𝗮𝗿𝗺: 𝗔 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 𝗼𝗻 𝗗𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆 𝗮𝗻𝗱 𝗜𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻 𝗶𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀." This piece underscores the essential role of diversity in clinical trial enrollment, emphasizing that inclusive approaches are vital for ethical, robust, and actionable research findings. In the US, the Food and Drug Omnibus Reform Act 2022 (FDORA) mandates clinical trial sponsors to submit "diversity action plans" for many trials, detailing their enrollment goals and strategies. This shift means diverse recruitment is now a legal requirement for those seeking US market approval. However, this raises questions about the impact on multi-regional clinical trials. How will these new requirements shape global studies? The conversation around global diversity in clinical trials is just beginning, and this publication is a crucial step forward. #ClinicalTrials #InclusiveResearch #HealthEquity #ResearchEthics Click here to access the article: https://bit.ly/3V8pGNH

With the introduction of the new Clinical Trials Regulation (CTR), concerns loom regarding the potential impact on Belgium's competitive edge for early-phase clinical trials. 🔍 Our question of the week explores if Belgium remains the perfect choice for your next early-phase clinical trial. 👇 Answer in the comments 👉 Read the full report https://lnkd.in/eMYz3bKq #clinicalresearch

Without a cross sponsor and cross therapeutic database registry like Verified Clinical Trials ™ there is no way to detect and prevent duplicate and professional research subjects right at the time of screening. The protections follow the subject the entire duration of the clinical trial. Verified Clinical Trials prevents many other important protocol violations too. Check out our new video here: https://lnkd.in/earHidc7 Or learn more at https://lnkd.in/etwhixy

Duplicate subjects can be a real problem in vaccine clinical trials and other therapeutic areas. Verified Clinical Trials ™ has the solution! The VCT global cross-sponsor research subject database registry detects and prevents duplicate subjects and other important protocol violations immediately at the time of screening. This protection follows the subject for the entire duration of the clinical trial, saving time and money for all stakeholders. VCT also reduces the placebo response and improves research subject safety, helping prevent clinical trial failure. Learn more at https://lnkd.in/etwhixy or watch one of our videos: https://lnkd.in/earHidc7 #professionalresearchsubjects #duplicatesubjects #verifiedclinicaltrials

Duplicate subjects can be a real problem in vaccine clinical trials and other therapeutic areas. Verified Clinical Trials ™ has the solution! The VCT global cross-sponsor research subject database registry detects and prevents duplicate subjects and other important protocol violations immediately at the time of screening. This protection follows the subject for the entire duration of the clinical trial, saving time and money for all stakeholders. VCT also reduces the placebo response and improves research subject safety, helping prevent clinical trial failure. Learn more at https://lnkd.in/etwhixy or watch one of our videos: https://lnkd.in/earHidc7 #professionalresearchsubjects #duplicatesubjects #verifiedclinicaltrials

The COVID crisis tested ECRIN’s capacity to respond to health crisis and showed how our network can unite to provide timely information to the European research community. While it strongly impacted our regular clinical study activity it also enabled ECRIN to evolve and take on new responsibility including among other a unique mechanism that coordinates some activities across the EU COVID19 platform trials and helps orient SME and other drug developers to the most appropriate open trial. #ECRIN10years #COVID19

Duplicate subjects can be a real problem in vaccine clinical trials and other therapeutic areas. Verified Clinical Trials ™ has the solution! The VCT global cross-sponsor research subject database registry detects and prevents duplicate subjects and other important protocol violations immediately at the time of screening. This protection follows the subject for the entire duration of the clinical trial, saving time and money for all stakeholders. VCT also reduces the placebo response and improves research subject safety, helping prevent clinical trial failure. Learn more at https://lnkd.in/eRK5k36 or watch one of our videos: https://lnkd.in/eHbTAMXa #professionalresearchsubjects #duplicatesubjects #verifiedclinicaltrials

Exciting News! Introducing the newly approved nonproprietary name for our lead therapeutic candidate ACU193: “sabirnetug"! What's a nonproprietary name for, anyway? Simply put, it's a drug’s universal unique name granted by the International Nonproprietary Names (INN) Programme and United States Adopted Name (USAN) Council to promote accurate identification, safety, and communication among health professionals and scientists worldwide. And, what’s in a name? The nonproprietary naming conventions represent a compound by its action, structure, or use. In effect, it helps tell the drug’s scientific story or mechanism of action to clinicians.