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Like clinical trials, outcomes research seeks to provide evidence about which interventions work best for which types of patients and under what circumstances. However, the evaluation methodology of outcomes research may include both experimental and non-experimental designs: further, the "intervention" being evaluated is not limited to ...
The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (NLM) Arm Any of the treatment groups in a randomized trial.
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 ...
Educational or Clinical Practices concern the provision of student-facing trauma-informed clinical interventions and educational practices. This can include trauma-informed teaching pedagogy or curriculum design; or trauma-specific clinical services such as trauma screening, mental health referrals, and multi-tiered intervention practices.
Discipline-based education research (DBER) is an interdisciplinary research enterprise that "investigates learning and teaching in a discipline [normally from the STEM fields] from a perspective that reflects the discipline's priorities, worldview, knowledge, and practices."
Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ...
Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.
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.