Henry, B.M.; Lippi, G.; Nasser, A.; Ostrowski, P. Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data. Curr. Oncol.2023, 30, 5932-5945.
Henry, B.M.; Lippi, G.; Nasser, A.; Ostrowski, P. Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data. Curr. Oncol. 2023, 30, 5932-5945.
Henry, B.M.; Lippi, G.; Nasser, A.; Ostrowski, P. Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data. Curr. Oncol.2023, 30, 5932-5945.
Henry, B.M.; Lippi, G.; Nasser, A.; Ostrowski, P. Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data. Curr. Oncol. 2023, 30, 5932-5945.
Abstract
Abstract: Our research analyzed the characteristics of phase IV clinical trials in oncology using data from the ClinicalTrials.gov registry. The included trials were conducted between January 2013 and December 2022 and were examined for key characteristics, including outcome measures, interventions, sample sizes, and study design, different cancer types, and geographic regions. Our analysis included 368 phase IV oncology studies. We found that 50% of these studies aimed to examine both safety and efficacy, while 43.5% only reported efficacy outcome measures, and 6.5% only described safety outcome measures. Only 16.9% of studies were powered to detect adverse events with a frequency of 1 in 100. Targeted therapies accounted for the majority of included studies (53.5%), with breast (32.91%) and hematological cancers (25.82%) being the most frequently investigated malignancies. Most phase IV oncology studies lacked sufficient power to detect rare adverse events due to their small sample sizes and instead focused on effectiveness. To ensure that there is no gap in drug safety data collection and detection of rare adverse events due to limited phase IV clinical trials, there is a significant need for additional education and participations by both health care providers and patients in spontaneous reporting processes.
Keywords
postmarketing surveillance; pharmacovigilance; registry data
Subject
Medicine and Pharmacology, Oncology and Oncogenics
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
