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