Understanding Clinical Studies Getting approval, registering the study and reporting your results
                     Understanding Clinical 
Studies: Getting approval, 
registering the study and 
reporting your results
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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.
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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.
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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.
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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.
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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.
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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.
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