MAC Clinical Research’s Post

Celebrating Innovation and Dedication on Clinical Trials Day 2024 🎉 Today, we honour the incredible contributions of clinical researchers and participants around the world on Clinical Trials Day. Their unwavering commitment to advancing medicine has played a pivotal role in enhancing healthcare for us all ❗ Clinical trials are the backbone of medical progress, providing us with valuable insights and leading to breakthroughs that save lives. The journey from the laboratory 🔬 to the patient’s bedside 🛏 is long and complex, but it’s through the dedication of countless individuals that we can turn possibilities into realities. Here are some impactful statistics that highlight the significance of clinical trials: ✔ The Association of Clinical Research Professionals (ACRP) has more than 16,500 members globally, representing a diverse and dedicated workforce. ✔ Clinical Trials Day is a tradition since 2014, celebrating the achievements and progress made through clinical research. ✔ The 2024 theme, “Trailblazers Among Us,” emphasizes the relentless pursuit of knowledge and the exacting application of best practices by clinical research professionals. Let’s take a moment to appreciate the hard work, innovation, and collaboration that go into every study. It’s through these efforts that we can look forward to a healthier future for everyone. 🙏 Thank you to all the researchers, healthcare professionals, and trial participants who make this possible. Your work does not go unnoticed, and the impact of your contributions will be felt for generations to come. #WeAreIQVIA #ClinicalTrialsDay #cFSPCares #SMSupports #HealthcareHeroes If you'd like to explore more about clinical trial conducted at IQVIA click on the link!

🗓️SAVE THE DATE🗓️ Workshop To Enhance Clinical Study Diversity - Public Workshop - Request for Comments November 29 and 30 from 10AM-2PM The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled “Workshop To Enhance Clinical Study Diversity.” This public workshop will satisfy a mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) for FDA to convene one or more public workshops to solicit input from various stakeholders on enhancing diversity in clinical studies.The public workshop will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative and will solicit input from interested parties on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence or incidence of the disease or condition among demographic subgroups, where appropriate. https://lnkd.in/gyzWNRpX Register at: https://lnkd.in/gjedn5wD National Center for Advancing Translational Sciences (NCATS) CTSA CCOS Center Cleveland Clinic Case Western Reserve University School of Medicine Case Western Reserve University School of Dental Medicine Weatherhead School of Management at Case Western Reserve University Case School of Engineering at Case Western Reserve University The University of Toledo Northeast Ohio Medical University (NEOMED) University Hospitals University Hospitals Clinical Research Center Louis Stokes Cleveland Vamc #healthequity #healthdisparities #translation #translationalresearch #translationalscience #diversityactionplans

International Clinical Trials Day 2024! Celebrate Clinical Trials Day this year, on May 20, 2024, by raising clinical trial awareness and honoring clinical research professionals across the globe. On Clinical Trials Day, take a moment to recognize the accomplishments of clinical research professionals in public health and medicine by recognizing their efforts in clinical trials. It is also a day to express gratitude to clinical research experts for their contributions to the advancement of public health through their work. The goal is to make this a primary focus for international communication activities, meetings, discussions, and celebrations of clinical research over this period as well. It is important to recognize that behind every breakthrough and every milestone, there are the people who make it possible – the trial participants / volunteers and clinical research employees – whose passion and commitment drive progress. As we look to the future, let’s continue to celebrate and support these trailblazers, for they are the pioneers of change. This year the theme is The Trailblazers Among Us, in celebration of modern-day trailblazers: clinical research professionals. They are the people who push the advancement of human health, and their dedication is what makes medical breakthroughs possible. #AXISClinicals #AXISINDIA #AXISUSA #AXISMEXICO #ClinicalTrials #Bioequivalence #Biostudies   #CDM #ClinicalDataManagement #ClinicalResearch #505B2 #VCStudies #PhaseI #PhaseII #PhaseIII   #PhaseTrials #PhaseItoIV #FirstInHuman #Regulatory #ClinicalDevelopment #axishyderabad   #axisahmedabad #AXISGlobalCRC #ClinicalTrials #InternationalClinicalTrialsDay2024 #ClinicalTrialsDay #Trailblazers

Today, the U.S. FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. Enhancing diversity within clinical studies not only facilitates broader applicability of results across a broad spectrum of patient populations, but also enhances understanding of the disease or medical product under study, thus providing valuable insights to inform the safe and effective use of the medical product among patients. #genomics #clinicaltrialdiversity #fda Draft Guidance: https://lnkd.in/eHUw3hVS

PHASE 1 CLINICAL TRIALS (PART 2) We did a post on Phase 1 clinical trials last week. Here's the concluding part of that post👇👇👇 Significance of Phase 1 Clinical Trials: Phase 1 trials serve as the foundation for subsequent phases of clinical development. Their significance lies in: Safety Validation: Identifying potential safety concerns at an early stage allows researchers to refine the intervention or, in some cases, discontinue development if safety issues are insurmountable. Dose Selection: Establishing the appropriate dose range is vital for maximizing therapeutic benefits while minimizing adverse effects in later phases. Advancing to Phase 2: Positive outcomes from Phase 1 trials pave the way for larger Phase 2 trials, where researchers further assess efficacy and safety in a broader participant group. Regulatory Approval: Data from Phase 1 trials are submitted to regulatory authorities as part of the approval process for advancing to subsequent phase. In conclusion, Phase 1 clinical trials are an integral and essential stage in the journey of medical innovation. By meticulously evaluating the safety and tolerability of new interventions, researchers lay the groundwork for the development of groundbreaking treatments and advancements in medical science. The dedication of both researchers and participants in Phase 1 trials fuels hope for improved healthcare and better quality of life for patients worldwide. #clinicaltrials #clinicalresearch #clinicaltrial #clinicalresearch #clinicalskillset #clinicalstudy #clinicaltrialmanagement

Did you know you can learn about the clinical trial outcomes of the original IMT on our website? Learn more about the following clinical findings: ↪️Improved vision ↪️Improved quality of life ↪️Visual Gains Are Long-lasting https://lnkd.in/ehvXNWp6 #Ophthalmology #MedicalDevice #ClinicalResearch 

"When FMVs Collide: Coming to Terms with Fair Market Value” Applied Clinical Trials Online, January 19, 2024 Norman M. Goldfarb With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value. As one of several experts cited in this informative article, Alethea Wieland, CEO and founder of Clinical Research Strategies, weighs in on the conflation of cost and value in the clinical research industry. https://lnkd.in/eTGmp6ni

Explore the Future of Clinical Research with Innovative Trial Designs. Learn how Single Arm Trials are reshaping the Life Sciences landscape in our latest blog. Read now!

📆 Today is International Clinical Trials Day! Clinical trials are used to assess the safety, efficacy, and use of treatment in humans so that a new medicine can be put on the market. One important aspect when initiating a clinical trial is making sure that the sample group is representative of the patient population. Recruiting patients from a variety of backgrounds allows us to refine the results in terms of treatment efficacy and safety according to the patient profile. At Servier, the clinical trials are managed by expert teams in 15 clinical development centers 🔬 divided into 3 hubs in the North and South America, Europe, and Asia-Pacific. According to Marta Garcia, Chief Patient Officer R&D at Servier, 🗣 “Our global geographic footprint, local teams’ high degree of expertise, and our new hybridized trial models are what put us in a position to improve our clinical developments every day – improvements not only in the diversity of the patients in our trials, but also in our understanding of local characteristics. It likewise allows us to forge stronger ties with the health care professionals and investigator centers involved.” Read more about Servier’s clinical trials 🗣 https://swll.to/dYA5g #CTD2024 #InternationalClinicalTrialsDay #ClinicalTrials #MovedByYou

Explore the Future of Clinical Research with Innovative Trial Designs. Learn how Single Arm Trials are reshaping the Life Sciences landscape in our latest blog. Read now!