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  2. Phases of clinical research - Wikipedia

    en.wikipedia.org/wiki/Phases_of_clinical_research

    A Phase IV trial is also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test. [1] Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives regulatory approval to be ...

  3. Outcome switching - Wikipedia

    en.wikipedia.org/wiki/Outcome_switching

    Changes in primary outcome metrics are present in nearly one in three studies. [5] Outcome switching also occurs frequently in follow-up studies. [ 6 ] In an analysis of oncology trials, outcome switching was more common in studies with a male first author, and in studies funded by non-profits. [ 7 ]

  4. Adaptive design (medicine) - Wikipedia

    en.wikipedia.org/wiki/Adaptive_design_(medicine)

    Schematic block diagram of an adaptive design for a clinical trial [1] In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis. [2] [1] [3] Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint. [1]

  5. Design of experiments - Wikipedia

    en.wikipedia.org/wiki/Design_of_experiments

    An experimental design or randomized clinical trial requires careful consideration of several factors before actually doing the experiment. [32] An experimental design is the laying out of a detailed experimental plan in advance of doing the experiment.

  6. Clinical study design - Wikipedia

    en.wikipedia.org/wiki/Clinical_study_design

    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 ...

  7. Outline of clinical research - Wikipedia

    en.wikipedia.org/wiki/Outline_of_clinical_research

    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

  8. Clinical trial - Wikipedia

    en.wikipedia.org/wiki/Clinical_trial

    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 ...

  9. Monitoring in clinical trials - Wikipedia

    en.wikipedia.org/wiki/Monitoring_in_clinical_trials

    Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...