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To illustrate the risk of inconsistency in the quality assessment of drug management program tools we selected two examples of how different methods of endpoint evaluation clearly impacted conclusions.
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Fig. 3 Choice of method of endpoint display.
To properly interpret the results of a given strategy and compare them with others, it is essential that there be agreement on the definitions and estimation methods of HSCT endpoints.
Let alone that the lack does not allow for development of predictive methods for endpoints like transformation and agglomeration potential.
The MVA plot [ 27], initially proposed by Bland and Altman [ 24, 26] to assess agreement between two methods of measuring an endpoint, is an intuitive examination of agreement that helps diagnose the magnitude and functional form of disagreements.
The FDA intends to determine the adequacy of study data to support claims in light of the prespecified method for endpoint analysis.
Finally, differing methods of displaying study endpoints can provide different views of the results.
Herein, the methods of CO2 expulsion and endpoint determination for the Boehm titration were standardized.
Topics covered include the choice of patients, choice of treatment and control groups, choice of primary and secondary endpoints, methods of randomization, appropriate use of blinding, and determination of trial size.
We report a survey of the recent HSCT literature that confirms the heterogeneity of endpoint definitions and estimation methods used.
We believe that the development of common joint register guidelines could play an important role by enabling coordination of the choice of modern statistical methods, selections, endpoints, and mode of reporting.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com