DSMBs and clinical trial safety

by Global Pharmacovigilance

The Data Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC – these are synonymous terms) is a group of individuals put together by the sponsor or CRO (if contracted out) with relevant expertise to carry out the important role of monitoring the safety of a clinical trial study.

1st June 2017 • comment

Epidemic curves are an important component of the public health and global health toolbox. Learn more about creating and interpretting them.

9th January 2017 • 2 comments

Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.

23rd December 2016 • comment

Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.

24th October 2016 • comment
1st December 2015 • comment
22nd September 2015 • comment

Healthcare associated infections (HAI) are of important concern in patient care. This talk discusses Visual Analytics techniques which have been developed to help detect, monitor, analyse and understand trends, clusters and outbreaks of HAI.

22nd July 2015 • comment

In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.

8th May 2015 • comment

Researchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial.  

10th May 2013 • comment

Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.

3rd April 2013 • comment

In this article, the authors illustrate five basic statistical concepts that can significantly impact the interpretation of the medical literature and its application to the care of patients, drawing examples from the vaccine literature: (i) consider clinical and statistical significance separately, (ii) evaluate absolute risks rather than relative risks, (iii) examine confidence intervals rather than p values, (iv) use caution when considering isolated significant p values in the setting of multiple testing, and (v) keep in mind that statistically nonsignificant results may not exclude clinically important benefits or harms.

26th March 2013 • comment

Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.

20th February 2013 • comment

A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.

9th August 2012 • comment

An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.

6th October 2010 • comment

Good data management practices are essential to the success of a trial because they help to ensure that the data collected is complete and accurate. This article contains some tips to help you get started with data management.

21st November 2009 • comment