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Understanding Clinical Studies: Getting approval, registering the study and reporting your results Group: pubrica.com Email: sales@pubrica.com
What Are Clinical Studies? Clinical studies are research involving human participants to improve prevention, diagnosis, and treatment of diseases. Each study is guided by a structured protocol that defines objectives, methods, and outcomes, and participants may include both patients and healthy volunteers. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica
Types of Clinical Studies Clinical studies can be interventional, where participants receive a treatment, or observational, where outcomes are only monitored. They may also be prospective, tracking subjects forward in time, or retrospective, analyzing past data to identify relationships. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica
Case-Control vs Cohort Studies Case-control studies compare individuals with a disease to those without, looking back to identify possible risk factors, while cohort studies follow groups over time to observe disease development. Both designs help establish associations and causes in medical research. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica
Obtaining Approval Before starting, studies must be reviewed by an Institutional Review Board (IRB) to ensure ethical conduct and participant safety. FDA-regulated and government-funded trials require approval, and the IRB ensures that potential risks are justified by anticipated benefits. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica
Study Registration Clinical trials must be registered before recruiting participants to ensure transparency and accountability. Registries such as ClinicalTrials.gov and the WHO ICTRP provide public access, and ICMJE mandates registration for publication, making results more accessible and trustworthy. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica
Reporting Results Reporting study results is vital for advancing medical practice and policy. Researchers should follow established guidelines, such as those recommended by the EQUATOR Network, to ensure accuracy and transparency, thereby enhancing the reliability and impact of their findings. sales@pubrica.com +44 161 394 0786 +91 9884350006 pubrica.com Copyright © 2025 pubrica
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