Abstract
BackgroundClinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis.ResultsOver the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01).ConclusionsThe CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC’s ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.
Highlights
Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices
Seven compensation events occurred during the oncology registration trials, and one was associated with a non-oncology trial
The basic tasks of clinical research coordinator (CRC) do not differ, the present findings indicate that CRC should pay close attention to the serious adverse events in oncology clinical trials due to the potentially higher frequency of serious complications in these types of studies
Summary
Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is widely recognized. Clinical research plays an important role in improving the quality of medical practice. The contribution of CRC must engage in the scientific and ethical pursuit of registration trials, and in assuring standards of quality by coordinating the activities and conduct of participants, investigators, sponsors, and various hospital staff. Among these duties, adverse event management, including proper and timely reporting to sponsors, is a key responsibility. CRC, as well as investigators, should pay close attention to serious adverse events, partly because these events may lead to compensation events which require additional resources and the involvement of administrative officers
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