Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
Yap C., Solovyeva O., de Bono J., Rekowski J., Patel D., Jaki T., Mander A., Evans TRJ., Peck R., Hayward KS., Hopewell S., Ursino M., Rantell KR., Calvert M., Lee S., Kightley A., Ashby D., Chan A-W., Garrett-Mayer E., Isaacs JD., Golub R., Kholmanskikh O., Richards D., Boix O., Matcham J., Seymour L., Ivy SP., Marshall LV., Hommais A., Liu R., Tanaka Y., Berlin J., Espinasse A., Dimairo M., Weir CJ.
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.