KAPLAN-MEIER CURVE
A graphical representation of survival probabilities over time in a clinical trial.
HAZARD RATIO
A measure comparing the risk of an event occurring in two groups over time.
COX PROPORTIONAL HAZARDS MODEL
A statistical method to explore the relationship between variables and time-to-event outcomes.
DOSE-RANGING STUDY
A study to determine the optimal dose of a drug by testing various dosages.
DOSE-ESCALATION STUDY
A study where doses are gradually increased to find the maximum tolerated dose.
MAXIMUM TOLERATED DOSE (MTD)
The highest drug dose that does not cause unacceptable side effects.
MEDIAN EFFECTIVE DOSE (ED50)
The dose at which 50% of the population experiences the desired therapeutic effect.
THERAPEUTIC INDEX
The ratio between a drug’s effective dose and its toxic dose, indicating safety.
ON-TREATMENT ANALYSIS
Analysis of data from participants who adhered to their assigned treatment regimen.
EXPLORATORY ENDPOINT
A secondary outcome used to generate hypotheses for future research.
PRE-SPECIFIED ANALYSIS
Analyses planned before the trial begins to avoid bias.
POST HOC ANALYSIS
Analyses conducted after data collection to explore unexpected findings.
SENSITIVITY ANALYSIS
Testing how robust the results are to changes in assumptions or methods.
GENERALIZABILITY
The extent to which trial results apply to broader populations outside the study.
EXTERNAL VALIDITY
The applicability of trial results to real-world settings.
INTERNAL VALIDITY
The degree to which a study’s results are trustworthy and free from bias.
INTERIM ENDPOINT
An outcome measured during the trial to guide decisions, like continuing or stopping the study early.
EARLY STOPPING
Halting a trial before completion due to clear evidence of benefit, harm, or futility.
WITHDRAWAL RATE
The percentage of participants who leave the study before it ends.
LOST TO FOLLOWUP
Participants who stop providing data during the trial for unknown reasons.
ATTRITION BIAS
Bias introduced by participants dropping out, affecting the study’s results.
SELECTION BIAS
Bias caused by differences in the baseline characteristics of treatment groups.
OBSERVER BIAS
Distortion of outcomes due to the researcher’s expectations or knowledge of treatment assignments.
DETECTION BIAS
Bias introduced by differences in how outcomes are assessed between groups.
PERFORMANCE BIAS
Differences in care or treatment other than the intervention being tested.
REPORTING BIAS
Selective reporting of results based on their nature, often omitting unfavorable outcomes.
Read also:
- Clinical Trial Terminologies | Part-1
- Clinical Trials with Decentralized Elements
- Effective Design of Clinical Trials | FDA
Resource Person: Brindha Chandrasekaran