Exact(1)
As such, in this context, it is evident that the availability of data from two PK and two efficacy studies of a protein pump inhibitor (PPI) for the treatment of heartburn complaints in adolescents should not be used to waive studies on the efficacy of a PPI for respiratory symptoms related to gastroesophageal reflux disease in preterm infants.
Similar(59)
In their paper, these authors propose that the availability of empirical data from two pharmacokinetic (PK) and two efficacy studies in children is enough to waive additional studies.
We agree with de Wildt et al. on the need to take children's developmental changes into consideration when assessing the clinical evidence in order to waive additional studies.
Read-across approaches and waiving of studies can also be justified.
In accordance with UK National Research Ethics Service guidance (National Research Ethics Service, 2008), ethical approval for the study was waived as the study was carried out retrospectively on routinely acquired data available to the principal investigator by virtue of his clinical role.
Written informed consent was waived in retrospective studies of anonymized patient data in under Ethical Guidelines for Medical and Health Research Involving Human Subjects.
Written informed consent was waived in retrospective studies of anonymized patient data under Ethical Guidelines for Medical and Health Research Involving Human Subjects.
According to the Dutch Medical Research Involving Human Subjects Acts (see http://www.ccmo.nl) approval by a medical-ethics committee is waived for such studies.
Since the TAASTIC trial is an observational study, a formal ethical approval was waived for this study by the OLVG Medical Ethics Committee.
Informed consent was obtained from the patient, but written consent was waived because this study was an anonymized case report.
The institutional human research board approval was waived for this study as it consisted of an educational quality initiative.
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