PCORI Help Center

Can one comparative-treatment intervention be a new option for patients? For example, can it be enhanced care based on the literature but not currently in routine practice?

Generally, a new option is less desirable than an option that is commonly available; however, if the new option has previously been demonstrated to be efficacious or effective in one or more controlled trials and you can provide evidence that it is likely to become commonly available, then it is legitimate to compare its real-world effectiveness with that of other available options.

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