BLINDED ADJUDICATION
A process where an independent committee reviews and classifies study outcomes without knowing which treatment group the participants belong to.
SUBGROUP ANALYSIS
An analysis conducted on specific subsets of participants (e.g., by age or gender) to explore differences in treatment effects.
NON-INFERIORITY TRIAL
A trial designed to demonstrate that a new treatment is not worse than an existing one by a predefined margin.
SUPERIORITY TRIAL
A trial aimed at showing that one treatment is more effective than another or a placebo.
EQUIVALENCE TRIAL
A trial that seeks to prove that two treatments have no clinically significant difference in efficacy.
MULTICENTER TRIAL
A clinical trial conducted at multiple locations to increase the diversity and generalizability of the results.
REGISTRY STUDY
An observational study that collects long-term data on participants with specific conditions or receiving specific treatments.
POST-MARKETING SURVEILLANCE
Studies conducted after a drug is approved to monitor its long-term safety and effectiveness.
PLACEBO CONTROLLED TRIAL
A trial where the test treatment is compared against a placebo to assess its true efficacy.
ACTIVE CONTROLLED TRIAL
A trial that compares the new treatment to an already approved and active treatment.
WITHDRAWAL DESIGN
A study design where participants are withdrawn from treatment to observe the effects of stopping the therapy.
RUN-IN PERIOD
A pre-trial phase where all participants receive the same treatment to ensure eligibility and compliance.
ENDPOINT DETERMINATION
The process of defining and measuring specific outcomes to evaluate the success of a clinical trial.
COMPOSITE ENDPOINT
A combined measure of multiple outcomes used to increase the efficiency of a trial.
SURROGATE ENDPOINT
A substitute measure, like a biomarker, used to predict clinical outcomes.
RISK-BENEFIT ANALYSIS
The assessment of a treatment’s potential benefits compared to its risks.
ALLOCATION CONCEALMENT
A technique to prevent bias by hiding the treatment allocation sequence from participants and researchers.
RANDOMIZATION SEQUENCE
The predetermined order of assigning participants to treatment groups, ensuring randomness.
CLUSTER RANDOMIZATION
A randomization method where groups (e.g., hospitals) are randomized instead of individuals.
STRATIFIED RANDOMIZATION
Randomization that ensures balance among treatment groups for specific participant characteristics.
BLOCK RANDOMIZATION
A method ensuring equal numbers of participants in each group within predefined blocks.
DYNAMIC RANDOMIZATION
A flexible method that adapts the allocation process to balance treatment groups as the trial progresses.
EVENT-DRIVEN TRIAL
A study where the duration depends on the occurrence of a specific number of events (e.g., deaths).
TIME-TO-EVENT ANALYSIS
Statistical analysis of the time until a specific event occurs, often used in survival studies.
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Resource Person: Brindha Chandrasekaran