Data monitoring committees: Promoting best practices to address emerging challenges

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene.

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...

Best practices for animal care committees and animal use oversight.

Regulatory authorities around the world with oversight responsibility for the welfare of research animals have placed heavily reliance on local oversight committees. These animal care committees (ACCs) are part of an institutional animal welfare team that includes the institutional administration, principal investigators, attending veterinarian and animal care staff, as well as regulatory organ...

Promoting better integration of health information systems: best practices and challenges

This report addresses the current trends in Member States of the European Union (EU) and European Free Trade Association (EFTA) on how to promote better integration of health information systems (HISs). To understand what better integration means from a pragmatic perspective, we conducted interviews with experts from 13 EU Member States, the results of which were combined with the findings from...

Licensing Challenges and Best Practices in China

For companies seeking to operate and expand in China, as in any market, numerous permits, approvals, and reviews are required before they can proceed. From selling products to creating new manufacturing facilities, these processes—often referred to generally as “administrative licensing”—are necessary steps to invest, expand and conduct commercial operations in China. While administrative licen...