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Table 2 List of IRDiRC task force report design and analysis topics and synonyms (topics in italics are not addressed in IDeAl’s publications)

From: Lessons learned from IDeAl — 33 recommendations from the IDeAl-net about design and analysis of small population clinical trials

adaptive design; adaptive/flexible design/study/trial
adaptive randomisation
adaptive selection
allocation ratio
ANCOVA
Bayesian method; method/analysis/design
benefit-risk
bias
biomarker; bio/genetic
clinical endpoint; endpoint/outcome
composite endpoint; endpoint/outcome/measure/response measure
cross-over
decision analysis, analysis/theory/making/process
disease mechanism
disease model
double-blind
drop-out
drug-disease model; model/modelling
early escape design
enhanced trial design
epidemiological study
extrapolation
factorial-design
group-sequential
high-risk allocation design
historic data
in-silico model; model/modelling/clinical trial
interim analyses
level-of-evidence
longitudinal data; longitudinal/repeated measures, model/data/outcome
micro-dose trial; trial/study
missing data; midding data/missingness
multi-arm design; multi arm/multiple treatment arm, design/study
multicenter
multiple endpoint; endpoint/outcome
multiple testing; multiple testing/multiple hypotheses testing
natural history
n-of-1; n-of-1/single-subject design
non-clinical data
non-randomised
parallel group
patient preference trial
patiet-centerdness, centerdness/centered
PCOM; patient-centered outcome measures
PD model; PD/pharmacodynamic
PIP; paediatric investigation plan
PK model; PK/pharmacokinetic
platform design; design/trial
post marketing
post-hoc
power
pragmatic trial; trial/study
prior data; data/distribution, informative Bayesian prior distribution
prognostic model; model/factor
public health strategy
randomisation procedure
randomised withdrawal
RCT; randomised controlled trial/study/design
registry
regulatory decision; decision/strategy
re-randomisation
response-adaptive method; method/design
sample size
sample size re-assessment; reassessment/re-estimation
seamless adaptive design
single-arm
SMART design; SMART/snSMART
subgroup; group/population
sufficient evidence
surrogate endpoint; endpoint/outcome/marker
time-to-event; survival endpoint/outcome/trial/study
trial simulation
validity