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Fun facts about Clinical Research: -Ethical Guidelines: The modern principles of ethical clinical research were established after the Nuremberg Trials following World War II, which exposed unethical medical experiments conducted by the Nazis. -Breakthrough Discoveries: Many breakthroughs in medical treatment, such as chemotherapy for cancer and insulin for diabetes, were made possible through clinical research. -Post-market Surveillance: Medical device clinical research extends beyond pre-market trials to include post-market surveillance studies, which monitor the device performance and safety in real world settings. Click the link below if you would like to learn more about the four phases of Clinical Trials. https://lnkd.in/gqfkJXni

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 

How valuable are digital endpoints to a clinical trial? 💭 Digital Medicine Society (DiMe)'s Sarah Valentine and Bert Hartog have the scoop on how digital endpoints can save time and money while still contributing to overall trial success. #clinicaltrials #clinicalresearch

#clinicaltrial https://lnkd.in/gYNMma2i Clinical trials are a fundamental component of #medical #research and serve as the main route to obtain #evidence of the safety and efficacy of treatment before its approval. A trial’s ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample size, and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial.

🚺 🏳️🌈 “For too long, women and SGM populations largely have been excluded from clinical trials and medical research—leading to unnecessary health inequities and negatively impacting the care these populations receive. To ensure that medications and medical devices are developed based on research that reflects their unique needs, we must increase the participation of women and SGM populations, as well as actively support the involvement of both women and SGM researchers in clinical research,” said AMA Board Member Toluwalase Ajayi, M.D. “Without this important data, there’s no way to know whether medications and medical devices are not only safe, but effective, for use in women and SGM populations.” 📌 “Under the new policy, the AMA will also support and encourage the National Institutes of Health, and other grant-making entities, to fund post-market research investigating pharmacodynamics and pharmacokinetics for generic drugs that did not adequately enroll women, and SGM populations in their clinical trials—prioritizing instances when those populations represent a significant portion of patients or reported adverse drug events.” https://lnkd.in/gW3MtMSm #healthequity #clinicaltrialequity #clinicaltrialdiversity #diversityactionplans #diversityinclinicaltrials

Understanding the Significance of Clinical Trials, part 5 In medical research, the design of clinical trials plays a pivotal role in ensuring unbiased and reliable results. ➗ In many trials, participants are divided into groups—one receiving an experimental treatment, and another undergoing standard care, placebo, or no treatment at all (sugar pill). 🕶️ Introducing the concept of "blinded" or "masked" studies, where participants remain unaware of whether they are getting the experimental drug or are placed in the control group. This strategy aims to eliminate the well-known "placebo effect," wherein patients feel better simply because they believe they are receiving a beneficial treatment. 👥 Taking it a step further, some trials are "double-blind" or "double-masked." This means that not only participants but also the study staff remain unaware of who is receiving the experimental treatment. The goal is to protect both patients and researchers from potential biases developed from their expectations. 👤👤👤 A triple-blind trial means that participants, clinicians, data collectors, and data analysts do not have access to details of group assignments. This ensures that bias for or against the tested treatment is very unlikely to occur. 🔬Blinding is particularly important in drug trials when the study is assessing subjective outcomes, such as relief of pain or anxiety. 👩⚕️👨⚕️ Treatment unblinding in a clinical trial must only be done when knowledge of the treatment is necessary to provide acute medical care or when there is safety or clinical concern. #clinicalresearch #clinicaldevelopment #qualitycultivator ------------ I'm Maria and I write about Quality in Clinical Research. If you like my content, please Connect or Follow and Hit the 🔔 on my profile to be notified about my posts. 📅 10Jan2023

Diversity & clinical trials: - Participants from different backgrounds. - A more realistic picture of the society. - Trials’ results will be more applicable to diverse populations. #clinicalresearch #clinicaltrials #regulatoryaffairs #medicalwriting

Are you looking for a comprehensive overview of #Clinical #Research? Check out Clinical Trials and Clinical Research: A Comprehensive Review https://lnkd.in/eJDsJHbn by Venkataramana Kandi and Sabitha Vadakedath. #clinicalresearch #clincialtrials #explainedclearly #reseachlandscape #ethicalconcerns, #audit, #therapeuticdrug, #efficacy, #medicalresearch

The FDA and NIH have collaboratively developed a glossary of clinical research terms to improve communication and scientific understanding within the research community. The glossary provides standardized definitions for 37 terms related to innovative clinical study designs, including the use of real-world data to generate real-world evidence. By establishing a common vocabulary, the agencies aim to help researchers better evaluate and communicate various aspects of clinical studies in a clear and consistent manner. Read the draft glossary here: https://lnkd.in/dwpJVvdn Comments are due by June 24, 2024. #clinicaltrial #drugdevelopment #RWE #RWD

I was catching up with my emails and happened to read the article: https://lnkd.in/gyKTWhXJ The incredible progress in clinical research is paving the way for novel treatments and transforming patient care. Breakthroughs in science and technology are driving unprecedented innovation, offering hope and healing to patients worldwide. The FDA's commitment to diversity, inclusivity, and patient-focused approaches is truly commendable. Enhancing the representation of underrepresented populations in clinical trials ensures that everyone benefits from medical advancements. We must remind ourselves to: 1) Stay Informed and keep up with the latest FDA guidances and initiatives to understand how these innovations can impact your work and the broader medical community. 2) Foster Collaboration by engaging with diverse patient groups and healthcare professionals to gather valuable insights and improve the generalizability of clinical trial outcomes. Together, we can harness the power of innovation to create a healthier, more equitable future for all. Let's continue to support and drive forward these transformative efforts in clinical research! #ClinicalTrials #Innovation #MedicalResearch #DiversityInScience #PatientCare