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In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [1]
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF ...
Randomized clinical trials analyzed by the intention-to-treat (ITT) approach provide unbiased comparisons among the treatment groups. Intention to treat analyses are done to avoid the effects of crossover and dropout, which may break the random assignment to the treatment groups in a study.
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
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 ...
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.
Case series have a descriptive study design; unlike studies that employ an analytic design (e.g. cohort studies, case-control studies or randomized controlled trials), case series do not, in themselves, involve hypothesis testing to look for evidence of cause and effect (though case-only analyses are sometimes performed in genetic epidemiology ...
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 ...