Tom Chwe OD, Dipl ABO’s Post

5 things you should know about clinical trials 1. Clinical trials are tests where doctors study new medicines or treatments by working with people. They do this to find answers to important health questions. 2. You choose to join a trial - it's never forced. If you start and then change your mind, you can stop at any time. 3. Sometimes, clinical trials need people who aren't sick to help. This lets doctors compare results between healthy people and those with illnesses. 4. Keeping you safe is very important. Researchers have to follow strict rules and safety guidelines set by the government to protect everyone in the trial. 5. Before you decide to join, the researchers will explain everything about the study to you. This is called "informed consent" - it means you understand what will happen before you agree to take part. Want to know if a clinical trial could be a good fit for you? Here's what to do: 1. Have a chat with your doctor about it. 2. Look for trials near you by visiting www.clinicaltrials.gov. 3. For more information:   - Watch some helpful videos https://lnkd.in/gCNbxJBe   - Find a list of questions you can ask the researchers You can get both of these at https://lnkd.in/gXMXFWkN. These steps can help you learn more and decide if joining a clinical trial is right for you.

Please involve patients in clinical trials! Patients should be involved in the clinical trial design, clinical trial cycle, eligibility requirements, and patient study information (websites/brochures). I just called about an asthma study. I wanted to know where the study locations were and if I met eligibility requirements. I was told I could not be given that information and that I needed to sign up and have my medical information reviewed. Took a look at Clinical trials. gov......there is not a study location close to me and based on medications that I am on, I meet exclusion criteria. Two simple questions that could not be answered by viewing the studies website or via the study information phone line. I did not want to waste my time or the study coordinators time by starting the process. Everyone's time is valuable. Patients can provide feedback on all aspects of a clinical trial. Patients want to be involved! #clinicaltrials #patients #Right2Breathe

🌐 Webinar Recap: Clinical Trial Management in Academic Medical Centers 🌐 We had the pleasure of hosting Dr. Tony Succar in our recent #OCRA-DG webinar! With experience across three major institutions, Tony Succar, PhD, MScMed(OphthSc) shared insights from his work on a bionic eye and a virtual vision rehab program, highlighting the essential role of clinical trials in developing new treatments. Key takeaways: 🔹 Over 500,000 trials registered on ClinicalTrials. gov underscore the need for effective trial management. 🔹 Strategies for participant retention, managing drug vs. device trials, and the unique challenges of pediatric trials. 🔹 Practical tips for improving trial success and participant experience. 📅 Looking ahead to 2025: #Join OCRA to access our exclusive webinars all year long and stay ahead! https://lnkd.in/gBeUJtGc #ClinicalTrials #WebinarRecap #JoinOCRA #ProfessionalDevelopment

Ultragenyx will add a fourth study group (also known as Cohort 4) to the Transpher A clinical trial. Ultragenyx is planning this new cohort to generate additional experience with UX111 to inform clinical practice. Key details include: • Up to eight patients will be enrolled. • There will be two trial sites. Both are in Spain and have prior experience with cross border international enrollment. • Travel and extended stay support will be available, if a patient is deemed eligible to enroll after evaluation by the site and if allowed by local regulations. More info: clinicaltrials.gov: https://lnkd.in/g3wFhduh

The journey of clinical trials is one of dedication, hope, and tireless effort. Recently, we had the privilege of having a couple of the PIs we work with visit the Clinibase office, and share the outcomes of their trials and the touching patient stories that highlight the true impact of this work. One story shared was about a patient with full-body, itchy atopic dermatitis, unsolvable by any existing treatments. After participating in a clinical trial, their life transformed from unbearable discomfort to normalcy - even a wedding! These moments remind us why we all do what we do. Working in clinical trials means dedicating countless hours with no guaranteed results. Yet, when breakthroughs happen, they are nothing short of miraculous. It’s a testament to the relentless effort and commitment of everyone involved—from the PIs and site teams to sponsors and CROs. Open, two-way communication is crucial in this field. Ensuring stakeholders understand each other’s processes and needs is key to success. From the recruitment perspective, the collective dedication and collaboration are what have led to outcomes, even for trials deemed “un-recruitable”. We are grateful to be part of this journey and to witness the incredible impact clinical trials have on people’s lives. Together, we are changing lives and advancing healthcare 🌟 #ClinicalTrials #HealthcareHeroes #PatientStories #MakingADifference #ThankYou

Why Sponsors Should Partner with Physician-Owned Clinical Research Sites 🤝🔬 Physician-owned sites offer unique benefits that can significantly enhance the success of clinical trials. Here's why partnering with them is a smart move: 🔹 Increased Patient Trust: Patients inherently trust us as their physicians, resulting in higher and quality enrollment rates and improved trial retention. 🔹 Better Compliance: Trust in physicians fosters adherence to study protocols, leading to accurate, high-quality data crucial for any trial success. 🔹 Enhanced Data Quality: Our passion for patient health enables early issue detection and personalized care, ultimately enhancing trial outcomes. 🔹 Stronger Patient-Physician Relationships: The existing connection boosts participant engagement, reduces dropout rates, and ensures reliable long-term data. 🔹 Streamlined Operations: Physician oversight ensures efficient communication and fewer protocol deviations, contributing to smooth trial operations. Partnering with physician-owned clinical research sites like HMG Clinical Research can truly elevate the quality and success of your clinical trials. #ClinicalResearch #Healthcare #PhysicianOwnedSites #ClinicalTrials #Chronicpainmanagement #CompassionateCare #Qualitydata

⏳ 5th September - Your chance to listen live to experts from Greenphire Timothy Dorsey, Steven Geffon, Dave Hine + Jaleeysa King https://lnkd.in/exixXBHA Recruiting and retaining patients for clinical trials can be challenging, dropout rates are around 30%. Sponsors are increasing payment and offering travel services to improve access, engagement, and diversity. How much should be budgeted for these critical solutions? Reserve your spot now to get the chance to learn more about: ☀ The burden associated with participating in a clinical trial ☀The best mix of clinical trial support ☀The tools to forecast and budget trial costs across phases, therapeutic areas and country ☀The ability to negotiate contracts with confidence

Let's talk about the importance of clinical trial transparency and the situation in Europe/US.    🔍  Weekly Bite-Size RA:  Clinical Trial Transparency: Why does it matter?     Clinical trial transparency is crucial for medical progress and public trust. Here's why making trial information and results publicly accessible is so important: 🌟 Key Benefits: • Fulfills ethical obligation to volunteer participants. • Enhances public trust in medical research. • Reduces bias in reporting of trial outcomes. • Accelerates scientific advancement and discovery of new treatments. • Supports better decision-making by clinicians and patients.   Europe: • New EU Clinical Trial Regulation 536/2014 came into force on January 31, 2022, replacing the Clinical Trials Directive. • Introduces a single EU portal for clinical trial applications and information. • Mandates publication of results summary within one year of trial ending.   UK: • Health Research Authority mandates registration and timely reporting of results. • Transparency is a condition of ethical approval for clinical trials.   United States: • FDA monitors compliance with ClinicalTrials.gov registration and results submission. • Results must be posted within 1 year of trial completion. • FDA takes regulatory action against non-compliance.   🌍 Global Trends: • Growing focus on sharing both positive and negative trial outcomes. • Increasing pressure on academic sponsors to improve reporting compliance.   💡 Why It Matters: "Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health." - European Commission, EMA, and HMA Joint Letter (2019)     #ClinicalTrials #Transparency #MedicalResearch #DrugDevelopment #RegulatoryAffairs #ResearchEthics #PatientSafety #DataSharing #OpenScience #RegulatoryCompliance #PharmaIndustry #HealthcareResearch #EvidenceBasedMedicine #MedicalEthics #ScientificIntegrity #PatientEngagement #Biopharma #DrugApproval #HealthPolicy

CLINICAL TRIAL DELAYS IMPACT LIVES—CAN WE DO BETTER? Clinical trials are the bridge between discovery and delivery. But nearly 80% of clinical trials are delayed due to recruitment challenges. These delays don’t just impact timelines—they affect patient access to potentially life-saving treatments. At TASK, we make it our focus to tackle these challenges head-on with tailored recruitment strategies and patient-centric solutions. Our drive? We understand that timely research is crucial for bringing hope and healing to those who need it most. https://task.org.za/ #ClinicalResearch #PatientEngagement #ResearchMatters #TASKSolutions

🌟 Celebrating #ClinicalTrialsDay – May 20th 🌟 Today, we celebrate Clinical Trials Day, a yearly occasion to acknowledge and honor the remarkable contributions of all individuals involved in the clinical trials ecosystem. From courageous patients and dedicated researchers to healthcare professionals, study sponsors, and regulatory bodies, each entity plays an indispensable role in advancing medical science and fostering the emergence of new treatments. 🙌 Patients: Your participation is priceless. By opting to join clinical trials, you propel medical progress, benefiting society at large. 👩⚕️ Researchers and Scientists: Your unwavering pursuit of knowledge and innovation propels the development of life-altering therapies. 🩺 Healthcare Professionals and Clinicians: Your expertise and compassion ensure that trials are conducted with utmost care and ethical standards. 🤝 Regulatory Bodies: Your guidance and oversight uphold the integrity and success of clinical trials. Together, we stride towards a future with reduced illness and enhanced quality of life for all. Let's persist in innovating, collaborating, and reshaping healthcare for the generations to come! #ClinicalTrialsDay #thankyou #healthandwellness #pharma #pharmanews #awarenessday