Standard 3: data monitoring committees.
نویسندگان
چکیده
Children are generally regarded as “vulnerable individuals.” There has long been reluctance to perform research in children except in limited settings such as pediatric cancer and vaccine development. However, avoidance of trials in children has resulted in uncertainty regarding efficacy, safety, appropriate formulations, and dosages of treatments in pediatric populations, a situation now recognized as problematic.1 As more pediatric clinical trials are undertaken, it is timely to focus on special issues in their design and conduct. One such issue is the monitoring of accumulating data from ongoing clinical trials.
منابع مشابه
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and condu...
متن کاملفلسفه وجودی کمیته‌های اخلاق بیمارستانی
In order to improve service quality, there are various committees in hospitals including ethics committees, which may be among the most important and necessary establishments within the health care system. Hospital ethics committees are designed to ensure proper clinical decision-making and are responsible for monitoring the ethical provision of services in hospitals. They also aim to assist pa...
متن کاملData sharing among data monitoring committees and responsibilities to patients and science
Over the past three decades it has become increasingly recognized that systematic assessment of as high a proportion as possible of relevant research evidence is needed to protect the best interests of patients and the public. For example, this principle is manifested in clinical guidelines and, increasingly, in the design and monitoring of new research. For scientific and ethical reasons, thos...
متن کاملMonitoring Board Committee Structure and Market Valuation in Large Publicly Listed South African Corporations Monitoring Board Committee Structure and Market Valuation in Large Publicly Listed South African Corporations
We examine the association between the presence of monitoring board committees (i.e., audit, nomination, and remuneration) and market valuation in South Africa using a sample of listed corporations. We find a significant positive connection between the presence of monitoring board committees and market valuation, but only in corporations that have independent monitoring board committees and/or ...
متن کاملMonitoring Board Committee Structure and Market Valuation in Large Publicly Listed South African Corporations
We examine the association between the presence of monitoring board committees (i.e., audit, nomination, and remuneration) and market valuation in South Africa using a sample of listed corporations. We find a significant positive connection between the presence of monitoring board committees and market valuation, but only in corporations that have independent monitoring board committees and/or ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- Pediatrics
دوره 129 Suppl 3 شماره
صفحات -
تاریخ انتشار 2012