Monitoring in clinical trialsClinical 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) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise.
Matching (statistics)Matching is a statistical technique which is used to evaluate the effect of a treatment by comparing the treated and the non-treated units in an observational study or quasi-experiment (i.e. when the treatment is not randomly assigned). The goal of matching is to reduce bias for the estimated treatment effect in an observational-data study, by finding, for every treated unit, one (or more) non-treated unit(s) with similar observable characteristics against which the covariates are balanced out.
Simple random sampleIn statistics, a simple random sample (or SRS) is a subset of individuals (a sample) chosen from a larger set (a population) in which a subset of individuals are chosen randomly, all with the same probability. It is a process of selecting a sample in a random way. In SRS, each subset of k individuals has the same probability of being chosen for the sample as any other subset of k individuals. A simple random sample is an unbiased sampling technique. Simple random sampling is a basic type of sampling and can be a component of other more complex sampling methods.
Validity (statistics)Validity is the main extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world. The word "valid" is derived from the Latin validus, meaning strong. The validity of a measurement tool (for example, a test in education) is the degree to which the tool measures what it claims to measure. Validity is based on the strength of a collection of different types of evidence (e.g. face validity, construct validity, etc.) described in greater detail below.
Patient recruitmentPatient recruitment includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $19 billion per year. Patient enrollment is the most time-consuming aspect of the clinical trial process. The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline.
MEDLINEMEDLINE (Medical Literature Analysis and Retrieval System Online, or MEDLARS Online) is a bibliographic database of life sciences and biomedical information. It includes bibliographic information for articles from academic journals covering medicine, nursing, pharmacy, dentistry, veterinary medicine, and health care. MEDLINE also covers much of the literature in biology and biochemistry, as well as fields such as molecular evolution.
Cochrane LibraryThe Cochrane Library (named after Archie Cochrane) is a collection of databases in medicine and other healthcare specialties provided by Cochrane and other organizations. At its core is the collection of Cochrane Reviews, a database of systematic reviews and meta-analyses which summarize and interpret the results of medical research. The Cochrane Library aims to make the results of well-conducted controlled trials readily available and is a key resource in evidence-based medicine.
Clinical trialClinical 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 study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.
Altered state of consciousnessAn altered state of consciousness (ASC), also called altered state of mind or mind alteration, is any condition which is significantly different from a normal waking state. By 1892, the expression was in use in relation to hypnosis, though there is an ongoing debate as to whether hypnosis is to be identified as an ASC according to its modern definition. The next retrievable instance, by Max Mailhouse from his 1904 presentation to conference, however, is unequivocally identified as such, as it was in relation to epilepsy, and is still used today.
Nonprobability samplingSampling is the use of a subset of the population to represent the whole population or to inform about (social) processes that are meaningful beyond the particular cases, individuals or sites studied. Probability sampling, or random sampling, is a sampling technique in which the probability of getting any particular sample may be calculated. In cases where external validity is not of critical importance to the study's goals or purpose, researchers might prefer to use nonprobability sampling.