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Clinical endpoint. 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 ...
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 ...
The Autism Diagnostic Observation Schedule ( ADOS) is a standardized diagnostic test for assessing autism spectrum disorder. The protocol consists of a series of structured and semi-structured tasks that involve social interaction between the examiner and the person under assessment. The examiner observes and identifies aspects of the subject's ...
Timothy Francis Leary (October 22, 1920 – May 31, 1996) was an American psychologist and author known for his strong advocacy of psychedelic drugs. [2] Evaluations of Leary are polarized, ranging from bold oracle to publicity hound.
Julie Schwartz Gottman. Julie Schwartz Gottman (born April 7, 1951) is an American clinical psychologist, researcher, speaker, and author. Together with her husband and collaborator, John Gottman, she is the co-founder of The Gottman Institute – an organization dedicated to strengthening relationships through research-based products and programs.
Adaptive design (medicine) 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. [1] [2] [3] Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint. [2] This is in contrast to traditional single-arm (i ...
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [2] as:
A serious adverse event ( SAE) in human drug trials is defined as any untoward medical occurrence that at any dose. Results in death. Is life-threatening. Requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. May have caused a congenital anomaly/birth ...