Table 4.

MCED evidence study design/methods acceptable by payers.

Study design feature	Percent (n/N) of payers who would accept a study with this feature for consideration in coverage decision for MCED testing (N = 19)
RCT vs. an RWE study
Data from rigorous RWE will be acceptable	63 (12/19)
RWE alone	47 (9/19)
RWE with a smaller non-phase III RCT	16 (3/19)
RCT is needed	37 (7/19)
Data modeling methods
Modeling complementing study data may be considered	47 (9/19)
Could be used to strengthen the data from trials	26 (5/19)
Could help extrapolate study results to additional cancers or populations	21 (4/19)
Modeling would not be considered in coverage decisions	53 (10/19)
Populations to study
Start with high- or elevated-risk population	42 (8/19)
Need to test in the populations intended for the use of MCED tests	58 (11/19)
How evidence will be evaluated
Individually for each cancer included in a test	79 (15/19)
In aggregate for all cancers included in a test	21 (4/19)

Note: MCED = multicancer early-detection; RCT = randomized controlled trial; RWE = real-world evidence.