Akesa’s Post

🔍 #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 🌟

Patient experience is key to decision-making for clinical trial design and operationalization. Sponsors focused on engaging research participants as partners and providing them with options. Decentralized clinical trial (DCT) elements provide patient flexibility. However, they are not widely used in all therapeutic areas. Have you explored Transcelerate's solutions for DCT elements in your clinical trials? Check it out the value story for the Modernizing Clinical Trials Conduct initiative about O-CAT. Hope you find this interesting and consider implementing in your clinical trials. Enjoy reading!

What Happens In Phase III Clinical Trials? What Happens In Phase III Clinical Trials? Phase III clinical trials involve large-scale testing to evaluate the effectiveness of a new drug or treatment. These trials typically include thousands of participants to determine how well the treatment works in diverse populations. The primary goal is to confirm whether the treatment offers a significant benefit over existing therapies. For students pursuing an MSc in Clinical Research at Shriram Medical College, understanding how to conduct these trials is crucial. The skills developed in this program are essential for coordinating and managing such large, complex studies. **Confirms Safety and Side Effects** A major component of Phase III trials is ensuring the safety of the treatment. After initial safety is established in earlier phases, Phase III trials focus on confirming the absence of major adverse effects. Researchers carefully monitor participants for side effects and ensure the treatment remains safe when administered to a broader population. Shriram Medical College’s MSc Clinical Research program teaches students to rigorously evaluate data for safety concerns, providing them with the knowledge required to oversee these critical trials. **Involves Diverse Participant Groups** Phase III clinical trials aim to test the treatment on a diverse range of participants to better understand its efficacy across different demographic groups. This includes varying ages, genders, ethnicities, and medical conditions. Shriram Medical College’s MSc Clinical Research students are trained to recruit and manage a wide spectrum of participants. They learn the ethical considerations involved in ensuring all groups are fairly represented, which is vital for creating treatments that benefit everyone. **Final Evaluation Before Approval** The final phase of clinical testing, Phase III, provides critical data before a new treatment can be approved by regulatory authorities like the FDA. Researchers must demonstrate that the treatment is both effective and safe to gain approval. At Shriram Medical College, the MSc Clinical Research program equips students with the expertise needed to compile, analyze, and present this data to regulatory bodies, preparing them for careers in regulatory affairs or clinical trial management. **Statistical Analysis of Trial** Phase III trials rely heavily on robust statistical analysis to interpret the outcomes. By using statistical methods, researchers assess the treatment’s effectiveness and compare it to existing therapies. Shriram Medical College’s MSc Clinical Research curriculum includes extensive training in biostatistics, ensuring that graduates can handle the complex data analysis needed in Phase III trials. This training helps students contribute meaningfully to large-scale clinical research projects, ensuring accurate and reliable results.

Site Feasibility, Country Feasibility...what about Patient Feasibility? 👀 👨⚕️ 👩⚕️ Patients are at the core of every clinical trial. It's planned with them and for them. Yet how can we conduct truly impactful trials without #amendments and failures because we failed to understand the patients? Patient data is complex and often can't be reduced to quantifiable insights— but not with TrialHub. 👇 We came up with Patient Feasibility for that exact purpose -> to quantify the patient burden. Let's see together what are the 5 steps you can take to perform patient feasibility, and have you been doing it all this time? #clinicaltrials #clinicalresearch #patientburden #patientsfirst #understandpatient #healthtech #pharma #pharmacompany #clinicalresearchorganizations #sitefeasiblity #countryfeasibility

Patient Focus is a corporate, enterprise imperative and flows through clinical development from there. One approach that holds great promise for development stage companies is for Program Team leadership to take the lead and develop and commit to a patient/ advocacy engagement plan with shared development and corporate reputational objectives. Corporate Communications can be a great partner. Companies can start by making sure program teams are intimately connected with the patient experience.

It's easy for drug development companies to say they're committed to supporting the patient engagement movement – but research shows otherwise. A recent survey from Tufts University shares that of several hundred companies polled, only 27% are routinely soliciting patient input into protocol design decisions. Aside from that, a recent CISCRP study found: ◾ Only 35% of clinical trial volunteers report receiving a formal verbal or written “Thank You." ◾ Less than 30% of clinical trial volunteers report receiving any information about the results of their clinical trial. If you want to become more patient-centric but don't have the bandwidth, resources, or know-how, we'd love to help. You can connect with us here: https://lnkd.in/gt6hD3Mn #patientsupport #patientcentricity #patientfocused 

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 FDA Guidance Unveiled: Blueprint for Breaking Barriers Big and exciting clinical trial update: The FDA has recently issued its draft guidance on clinical trial diversity, detailing requirements for racial and ethnic diversity action plans. This comprehensive document outlines how to format and submit these plans, emphasizing recruitment goals aligned with disease prevalence. Companies are expected to set recruitment goals for various racial groups, categorized by age and gender, and to explain their rationale and strategies for achieving these goals. This initiative aims to improve representation in clinical trials and enhance the validity of safety and efficacy studies. In what ways do you think the FDA's new draft guidance on clinical trial diversity will influence the development and approval processes of medical products in the future? How can companies adapt their recruitment strategies to align with the FDA's new guidelines? “Participants in clinical trials should be representative of the patients who will use the medical products,” says Robert Califf, the FDA commissioner. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.” Read more in the article in the comment below. #FDA #ClinicalTrials #DiversityInResearch #HealthcareEquity #MedicalResearch #FDAguidance #InclusiveTrials #PatientRepresentation #HealthcareDiversity #ResearchDiversity #TrialRecruitment

As of January 17, 2024, close to half a million clinical trials were registered globally. Clinical trials are the cornerstone of medical research, ensuring that new treatments, medicines, and therapies meet rigorous standards of safety and efficacy before reaching the public. Read the blog to learn about the types and phases of clinical trials and how clinical laboratory management software bolsters the entire spectrum of clinical trials. https://zurl.co/CMdn #LIMS #clinicallabmanagementsoftware #clinicalresearch

Are decentralized clinical trials needed for all studies?