Ad-hoc Analyses

Ad-hoc or Post-hoc Analyses are usually performed once a database is locked and serve as supplementary investigations beyond the planned analyses (ie, those included in the protocol or statistical analysis plan). These analyses are typically conducted in response to unexpected findings or to gain further insights into the study data. Therefore, these additional analyses are more exploratory in nature. Examples of such analyses include subgroup analyses, correlations between endpoints, or trying different statistical methods (from those planned).

 

While acknowledging the potential for bias, Ad-hoc or Post-hoc Analyses play a vital role in deepening the understanding of the study data. It is essential to delineate these analyses clearly in study reports, to maintain transparency and ensure the findings are properly interpreted. The expertise of an Emtex Statistician can guide the adequate application and execution of statistical approaches.

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We would like to thank you thoroughly and emphasize that we very much appreciated your review. Both we and the sponsor have repeatedly stressed during the meetings that your review has been a great value to the quality of our documents. Thank you for this collaboration!

Clinical Research Associate