Clinical Trial Baseline

A Clinical Trial Baseline is a Dataset that contains information and/or measurements gathered at the beginning of a clinical trial.

AKA: Medical Baseline, Clinical Research Baseline, Clinical Trial Reference Point.
Example(s):
- participants' physical exams recorded at the beginning of a clinical trial,
- participants' laboratory tests recorded at the beginning of a clinical trial,
- participants' medical assessment recorded at the beginning of a clinical trial,
- …
Counter-Example(s):
- Interferometer Baseline Vector,
- Baseline Model.
See: Clinical Trial Audit Trail, Clinical Trial Management System, Electrocardiogram, Medicine, Baseball Baseline.

References

(Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Baseline_(medicine) Retrieved:2021-11-19.
- A baseline in medicine is information found at the beginning of a study or other initial known value which is used for comparison with later data. The concept of a baseline is essential to the daily practice of medicine in order to establish a relative rather than absolute meaning to data. The meaning of baseline in medicine is very similar to that of the running baseline (baseball) being the direct path that a baserunner is taking to the base he is in route to. If the baserunner is outside the 3 foot margin around his running baseline, then he is considered out. Whereas if a patient with kidney failure (whose creatinine is usually 3.0 mg/dL) suddenly has a creatinine of 5.0 mg/dL, then his creatinine is out of his normal. For that person with kidney failure, absolute normal no longer applies because he will never again be able to obtain an absolutely normal creatinine level (0.5–1.2 mg/dL) with kidneys that no longer function properly.

(Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-19.
- QUOTE: Baseline
  - 1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. (NLM)
  - An initial measurement that is taken at an early time point to represent a beginning condition, and is used for comparison over time to look for changes. For example, the size of a tumor will be measured before treatment (baseline) and then afterwards to see if the treatment had an effect. (NCI)

(MedicineNet, 2021) ⇒ https://www.medicinenet.com/baseline/definition.htm Retrieved:2021-11-19.
- QUOTE: Baseline: Information or data gathered at the beginning of a period from which variations that subsequently develop are compared.

(NIA/NIH, 2021) ⇒ https://www.nia.nih.gov/research/dgcg/nia-glossary-clinical-research-terms Retrieved:2021-11-19.
- QUOTE: Baseline – The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.

(ClinicaTrials.gov, 2021) ⇒ https://www.clinicaltrials.gov/ct2/about-studies/glossary Retrieved:2021-11-19.
- QUOTE: Baseline characteristics
  - Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).