• Sao Paulo Med J · Jan 2023

    What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study.

    • Rafael Leite Pacheco, Ana Luiza Cabrera Martimbianco, and Rachel Riera.
    • MSc. PhD. Physician and Researcher, Centre of Health Technology Assessment, Hospital Sírio-Libanês, São Paulo (SP), Brazil. Researcher, Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. Professor, Centro Universitário São Camilo, São Paulo (SP), Brazil.
    • Sao Paulo Med J. 2023 Jan 1; 142 (1): e20220634e20220634.

    BackgroundAlthough the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway.ObjectiveTo analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources.Design And SettingThis meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil.MethodsWe performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials.ResultsWe identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study.ConclusionThe concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

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