Table 2.

Simulation conditions, assumptions, and trial design parameter space

	MAMS		BAR
Parameters	Phase IIc	Seamless II/III	Phase IIc	Seamless II/III
Maximum patients	100 per arm	400 per arm	100 per arm	400 per arm
Recruitment rate	10 patients/week		10 patients/week
Culture and data lag time	6 weeks		6 weeks
Proportion of easy/moderate/hard to treat sub-populations	0.33 | 0.33 | 0.33		0.33 | 0.33 | 0.33
Intermediate and surrogate endpoints evaluated	TCC HR	TCC HR TS-52	TS-8 TS-24	TS-8 TS-24 TS-52
Number of interim analyses	1–2*	2–3*	–	–
Timing of interim analysis	10–100 patients*	100–400 patients*	–	–
Interim criteria	TCC HR threshold: 1.1–2.3* Relapse % threshold: 4–20%*		–	–
Equal recruitment period (before adaptive algorithm is initiated)	–	–	10 patients per arm	10–50 patients per arm*
Bayesian adaptive randomization tuning parameters	–	–	Nonaggressive–Aggressive ɣ = 1–25* η = 0.1–2.0*
Trial stopping rules	–	–	4 Arms reach max N	3 Arms reach max N
Priors	–	–	–	Optimistic* Skeptical*

*Indicates trial design parameters that were explored, and optimized