Risk-adjusted Phase II clinical trial
A risk-adjusted Phase II clinical trial is an early-phase efficacy design that incorporates patient baseline risk strata — such as disease severity, prognostic score, or comorbidity burden — directly into the trial's stopping rules and sample size calculations. By conditioning response targets and futility/efficacy thresholds on risk group membership, the design avoids the bias that arises when a new therapy is evaluated in a population whose prognostic mix differs from the historical control on which the null hypothesis was based.
Izvorni zapis
Citati kopirani doslovno iz izvornog zapisa metode. Ne impliciraju nikakvu provjeru na razini tvrdnje.
- Thall, P. F., & Simon, R. (1994). Practical Bayesian guidelines for phase IIB clinical trials. Biometrics, 50(2), 337–349. · DOI 10.2307/2533377
- Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10(1), 1–10. · DOI 10.1016/0197-2456(89)90015-9
Uređene tvrdnje
Tvrdnje pohranjene u knjigu dokaza, svaka s vlastitom procjenom.
Ovaj prikaz ne izmišlja procjenu tvrdnje kada knjiga dokaza nema nijednu.
Povezane metode
Generirano iz grafa metode i prikazano kao strojno predložene relacije — ne implicira se nikakva tvrdnja dokaza.
Generirani graf relacija nema izlaznu relaciju za ovu metodu.