Medicines and Healthcare products Regulatory Agency’s Post

Folks...!!! Excited to share my latest achievement! I am thrilled to have successfully completed the "Clinical Trials" from NDAT CTN Clinical Coordinating Center" Course✅ The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is based on several key principles and objectives are: ✅ Collaboration: The CTN promotes collaboration among researchers, clinicians, and diverse community-based treatment programs. ✅Pragmatic Trials:CTN emphasizes conducting pragmatic clinical trials that evaluate interventions in real-world settings, such as community treatment centers. ✅Patient-Centered Research: The network prioritizes research that addresses patient-centered outcomes and concerns. ✅Implementation Science:CTN incorporates principles of implementation science to study methods for integrating evidence-based practices into routine clinical care. ✅ Diverse Populations: There is a focus on including diverse populations in research studies to ensure that findings are applicable across different demographic groups, including racial and ethnic minorities, and individuals with co-occurring disorders. ✅ Dissemination and Training: The CTN aims to disseminate research findings to practitioners, policymakers, and the public, and provides training and education to enhance research capacity within community treatment programs. On: 26th July 2024 Organized by :- Eve Jelstrom Principal Investigator, NDAT CTN Clinical Coordinating Center, University of Washington in Seattle, Washington, USA #National_institute_Drug_Abuse #Clinical Trials #medicine

On May 20th, we are honoring 🎉 International Clinical Trials Day, a day dedicated to raising awareness 📢 and recognizing the tireless efforts of everyone involved in clinical trials. This date pays tribute to one of the first randomized clinical trials, initiated on the same day in 1747 by James Lind (1716–1794). Representing 10 statistical associations across Europe, we at #EFSPI are committed to maintaining professional statistical standards, especially in the context of clinical trials and their methodologies. Quantitative decision-making is an integral part of clinical trials, but the quality of the analysis and interpretation of the evidence are directly tied to the quality of the data. Healthcare professionals, researchers, and all staff at clinical trial facilities work tirelessly each day to gather and provide high-quality data that meets the objectives set out in the clinical trial protocol. Their role is fundamental in the process, often undertaken in demanding circumstances. We also want to acknowledge the patients who participate in these trials. Their trust, courage and resilience are vital to the progression of medical science. Their participation in clinical trials paves the way for improved treatments and therapies, ultimately enhancing patient care worldwide. We invite you to take a moment to reflect on the importance of clinical trials and express your gratitude for those who dedicate their days to this important work. Their contributions are key to improving patient outcomes. 🙏 #ClinicalTrialsDay #collaboration #gratitude

💡 New ECRIN Publication 💡 We are proud to have participated in the publication of this article: "Mapping of Data-Sharing Repositories for Paediatric Clinical Research - A Rapid Review" in Data, published by MDPI. 📰 This paper explores the landscape of data-sharing repositories for paediatric clinical trial data, highlighting the need for targeted initiatives to promote awareness and establish common standards. Get all the details here: https://lnkd.in/eYsT_Gsj 👀 #Paediatric #DataSharing #ScientificPublication

📑 I've seen hundreds of patient information sheets and informed consent forms as a medical translator, and I believe this template is a huge improvement in terms of flow and readability. They've used bold formatting of keywords, added icons to level 1 headings, used more lists and tables than usual — and magic happened.✨ Even the text about data protection and confidentiality looks friendlier than usual. #clinicaltrials #informedconsentform #clinicaltrialdocuments #patientinformationsheet #patientinformation #plainlanguage #informedconsent #ICF #consentform #writing #medicalwriting

Our Clinical Research Network (CRN) has announced its annual research statistics for 2023/24. The key stats provide insight into how we're supporting health and care research nationally. 🔵 1 in 4 people who participated in research in England last year were recruited via primary care with over 56% of GP practices supporting CRN Portfolio studies, making research easier to access and take part in for participants. 🔵 11% of care homes in England took part in research that will improve adult social care, including studies on isolation for residents with sight loss and alcohol use in care homes. 🔵 Another fantastic year for recruitment with more than 1 million participants taking part in health and care research studies across England in 23/24. This means that participation is up on pre-pandemic levels for the fourth year in a row. 🔵 There was also a record performance for our annual Participant Research Experience Survey (PRES), with 35,519 responses from people who had participated in research - 9% increase on the previous year. These responses help us improve participant experience of future research. Thank you to everyone who contributed to supporting the delivery of health and care research across England last year. Read all our results here ➡️ https://lnkd.in/eUrAFdN8

Ensuring representation and inclusion is critical to effective, impactful clinical trials. A recent article in STAT highlighted the unfortunate failure of an NIH pilot project that aimed to increase diversity in clinical trials. Read the article here: bit.ly/4er5xtS The outcome of this project highlights the need for everyone involved in clinical trials to commit to improving, and sustaining, equitable and inclusive practices for underrepresented populations. Looking to learn more?  The 3CTN offers an Equity, Diversity and Inclusion Framework and Toolkit to support sites, clinical research staff, sponsors, and funders at https://lnkd.in/g4bJvK5W

📢 Calling our Patient Organisations: Your help is crucial in shaping the future of pediatric clinical trials across Europe! The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) needs your input for their new research project. They're gathering insights from Clinical Research Units and parents of children living with diseases to understand: 1️⃣ How language barriers affect access to cross-border pediatric clinical trials. 2️⃣ Preferences from those with no clinical trial experience. Your feedback will help create guidelines that ensure all children, regardless of their mother tongue, can participate in clinical trials. Thanks to the important dedication of the working group, volunteers, and EUPATI Fellows, this survey is available in all European official languages to ensure everyone gets a say on the matter🗣️ 📝 Take the survey here: https://lnkd.in/dqcFYha4 ⏳ Deadline: September 30th, 2024 #EMA #EUPATI #ClinicalTrials #Survey #Shareyourinput

Such a pleasure to contribute and add my insights to this article for the BMJ https://lnkd.in/dSSMMeNC

Reposting these texts from the patient-lex issue of the BMJ This as they provide some most insightful reading about the role of patients in research ...and more

Delighted to share that our Site Engagement work has once again been recognised at the Communique Awards. 'Saving a Place for Patients', our drive to place patients at the heart of a phase 1 investigator meeting, was a standout winner in the 'Excellence in Global Education Meetings / Stand-Alone Events' category. This project shed light on a clear, unmet need. While clinical research sites play a vital role in trial recruitment and retention, historically, investigator meetings focused on the science, data, and procedures - rather than how best to communicate the trial to patients and support them through consent and participation. Central to 'Save a Place' was the experience of people living with moderate to severe asthma, which resonated with attendees and Communiqué judges both: "The storytelling was brilliant, and it was a really important topic to improve diversity in clinical trials," commented the judges. "They put patients at the heart of the whole project, which was fantastic." If you would like to hear more about the project, please don’t hesitate to reach out April Campbell Chloe Gower-Page Roland Barter #PatientEngagement  #ClinicalTrials #InvestigatorMeetings