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Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.

 

Comments:

Thank you for providing information about the CONSORT-DEFINE guidance. CONSORT-DEFINE is indeed an extension of the CONSORT statement, which provides guidelines for reporting randomized trials. This extension specifically addresses early phase dose-finding trials that involve interim dose escalation or de-escalation strategies. These trials play a crucial role in determining the safety, tolerability, and activity of new treatments, as well as recommending dosing and scheduling regimens for further clinical development.

Inadequate reporting of such trials can hinder the understanding of their results and impact evidence-based decision-making in the field of medicine. CONSORT-DEFINE aims to address this issue by offering a set of recommendations for essential items that should be reported in early phase dose-finding trials. By following these guidelines, researchers can promote transparency, completeness, reproducibility, and clarity in the reporting of their studies. This, in turn, enhances the informativeness and usefulness of the trial results, facilitating better interpretation and application of the findings in clinical practice and future research.

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