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Baseline characteristics. Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
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The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries.
In Section 5, important elements of clinical study design are described that reflect the variety of designs used in drug development as well as the range of data sources available. Section 6 addresses study conduct, ensuring the safety of study participants, and study reporting.
20 cze 2023 · Drug trials are clinical research trials conducted to evaluate the safety and efficacy of various drugs in human subjects. The purpose of drug trials is to search for new and improved medications for the prevention and treatment of different medical conditions, as well as to examine known drugs that warrant further study and comparison.[1]
26 cze 2024 · Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and ...
The ICH guideline 'General considerations for clinical studies' is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities, provide guidance on the consideration of quality in the design and conduct of ...
23 gru 2022 · Nature Medicine asks leading researchers to name their top clinical trial for 2023, from cervical and prostate cancer screening to new drugs for Parkinson’s disease and Alzheimer’s disease.
