Data Monitoring Committees: Current issues

Standard 3: data monitoring committees.

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 recog...

Data monitoring committees: history and their future

Data Monitoring Committees (DMCs), sometimes referred to as Data & Safety Monitoring Boards, have had a successful history over four decades in both government and industry sponsored trials. Their primary mission is to independently evaluate the accumulating data in an on-going clinical for the risks and benefits on behalf of trial participants, investigators, sponsors and regulators. DMCs can ...

Bioethical committees and data protection issues in Poland

In Poland there are only Regional Bioethical Committees. Unlike most EU countries Poland has no coordinating centre on bioethics for human research. However, the Ministry of Health and Welfare has established a Bioethics Appeals Committee.The functioning of the Bioethical Committees in Poland is regulated in detail by the Regulation of the Ministry of Health and Welfare of 1999. All regulations...

Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees.

This is a commissioned report by a writing committee formed by the Society for Clinical Trials. The committee was formed with the objectives of 1) reviewing data monitoring guidelines for confirmatory (phase III) trials published by the National Institutes of Health, US Food and Drug Administration, Veterans Administration, and the International Conference on Harmonisation and 2) proposing corr...

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene.