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

A prospective, qualitative, multi-site study investigating the barriers and enablers to locally-led clinical trial conduct in Ethiopia, Cameroon, and Sri Lanka; here the protocol, methods and instroduction are available for readers. 

6th April 2017 • comment

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

New articles from the African Society for Laboratory Medicine (ASLM).

13th November 2015 • comment

Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.

19th October 2015 • comment

Professor Bongani M Mayosi from the Department of Medicine, Groote Schuur Hospital & University of Cape Town describes the transofmation of the science cohort in South Africa.

14th May 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

UK EQUATOR Centre Publication School: Writing research articles fit for purpose - Learn the secrets of success in writing, publishing, and disseminating your research. 6th Julay 2015, University of Oxford.

27th March 2015 • comment
2nd February 2015 • comment

Discussing the study protocol part 2

by D. Shamley, N.Kramer, E.Allen, L.Workman, W.Smythe, C.Ovenstone, C.Reddy
30th January 2015 • comment

Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.

14th October 2014 • comment

Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:

  • CONSORT Statement (reporting of randomized controlled trials)
  • STARD (reporting of diagnostic accuracy studies)
  • STROBE (reporting of observational studies in epidemiology)
  • PRISMA (reporting of systematic reviews)
  • MOOSE (reporting of meta-analyses of observational studies)

26th October 2012 • comment
19th July 2012 • comment

It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.

9th June 2011 • comment

This paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.

24th January 2011 • comment

The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

5th January 2011 • comment

A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.

29th November 2010 • comment

This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.

5th November 2010 • comment

An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.

1st November 2010 • comment

What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.

2nd February 2010 • comment

An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.

21st November 2009 • comment

Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.

21st November 2009 • comment

Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.

21st November 2009 • comment

Ticking the last box: once the trial has ended it is important to ensure correct site closure and archiving of study files.

21st November 2009 • comment

Considerations for pharmacovigilance and safety reporting.

21st November 2009 • comment

Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.

21st November 2009 • comment

The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.

21st November 2009 • comment

What is the definition of a clinical trial? Is there an international consensus? Read on to find out.

21st November 2009 • 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

Clinical trial regulations can be confusing and unwieldy to researchers. The intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.

21st November 2009 • comment

The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.

21st November 2009 • comment