Can significant results in the primary outcome of a pilot RCT (n = 50) with prespecified confirmatory analysis be interpreted as class 1 evidence as it would have been in a full scale trial? That means, is it possible to conclude from a pilot trial that a significant effect in the primary outcome means that the intervention improves the targeted outcome or is it still necessary to run a larger full-scale trial to confirm the hypothesis again?
Significant results obtained in the primary outcome of a pilot RCT (n = 50) with prior confirmatory analysis cannot be interpreted as sufficient evidence as would be the case in a full trial. Pilot trials are primarily designed to assess feasibility, methods and procedures. If the result is positive, a larger, definitive trial may then be considered. Pilot trials are not intended to provide definitive conclusions about the effectiveness of an intervention.
To obtain sufficient evidence, it is necessary to conduct a large, full trial that includes a sufficient sample size (and therefore sufficient power) to validate the results and reduce sampling bias. The results of a pilot trial may indicate a promising trend, but they must be confirmed by a more rigorous and larger trial to be considered conclusive.
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