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Abstract:
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The standard opt-in approach to consent in clinical trials assumes a default of non-participation and requires active engagement, yielding low accrual rates, a highly selected population, and limited generalizability. Research in behavioral economics has revealed the importance of defaults, and suggests setting the default to participation, while still allowing participants to opt out. Opt-out approaches increase accrual rates and improve representativeness of the target population, increasing generalizability. Both willingness to consent and responsiveness to treatment may be a function of internal "motivation." If barriers to participation in opt-out settings are reduced, less motivated subjects may participate; such participants may also be less responsive to treatment. The tradeoff between the more representative population and the smaller treatment effect, in terms of study power, is currently unknown. We conducted simulations to evaluate the effect of different consent approaches; varying proportions of motivated and unmotivated participants in the target population; different rates of consent and different treatment effects in motivated and unmotivated participants.
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