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A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...
Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.
Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials
Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. [1] When expressed specifically, a clinical trial phase is capitalized both in name and Roman numeral, such as "Phase I" clinical trial. [1]
Clinical trials are medical research studies conducted on human subjects. [1] The human subjects are assigned to one or more interventions, and the investigators evaluate the effects of those interventions. [1] [2] The progress and results of clinical trials are analyzed statistically. [3] [4]
Randomized controlled trial [5]. Blind trial [6]; Non-blind trial [7]; Adaptive clinical trial [8]. Platform Trials; Nonrandomized trial (quasi-experiment) [9]. Interrupted time series design [10] (measures on a sample or a series of samples from the same population are obtained several times before and after a manipulated event or a naturally occurring event) - considered a type of quasi ...
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
A typical area of academic clinical trials is the advancement and optimization of already existing therapies. Thus, academic clinical trials may for instance test how a combination of registered drugs may improve treatment outcomes; or they may apply registered treatments in additional, less frequent indications.