A Guide to Efficient Trial Management

by The Trial Manager's Network

This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 5th Edition (2016)

13th May 2018 • comment

There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required.

30th January 2017 • comment

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).

17th November 2016 • comment
28th September 2016 • comment

Professor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.

20th July 2016 • comment

Global Health Glossary

by The Editors

This glossary provides definitions of some common terms encountered in clinical research.

23rd February 2016 • comment

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

19th October 2015 • comment
22nd September 2015 • comment

This article provides a helpful introduction to statistics as it relates to clinical research, explaining common terms and theories with examples and case studies. Powerpoint presentation also attached for further explanation.

24th July 2015 • comment

Field trials of interventions against disease in low and middle income countries (LMICs) may be complex and expensive undertakings. This 3rd edition of the Field Trials Toolbox has been compiled by over 30 contributors with extensive direct experience in the design, conduct, and analysis of field trials in LMICs, and it attempts to document their accumulated experience for the guidance of those who might undertake field trials of health interventions. It can be read in its entirety as an introduction to the field and/or can serve as a reference volume during each of the different stages of planning, conducting, and analysing a field trial.

13th July 2015 • comment

Las solicitudes para fondos o apoyos difieren substancialmente dependiendo de la organización a la que se esté aplicando, ya que cada una de ellas tiene sus propios objetivos organizacionales, los cuales es importante entender cuando se está considerando a que fondo o apoyo aplicar. En este artículo ofrecemos consejos prácticos e información para escribir solicitudes para fondos o apoyos, los cuales pueden ser aplicados a solicitudes de todo tipo, desde becas hasta solicitudes para financiamientos grandes.

7th July 2015 • comment

Grant applications differ substantially depending on the individual funding organisation, and each funding organisation has its own organisational aims, which are important to understand when you are considering which grant to apply to. In this article we provide practical tips and information for writing grant applications, which can be applied to grant applications of all sorts, from fellowships to large funding applications.

7th July 2015 • comment

Are you a research scientist working in Global Health? Or an institution looking for partners to run a clinical trial? Site Finder is for you.

5th June 2015 • comment

In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.

3rd June 2015 • comment

Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked. 

2nd June 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

Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.

31st March 2015 • comment

Research Administration and Grant Management

by Research Administration Tools.org

Links to resources provided by iRIM (the Initiative on Research and Innovation Management) - free online presentations and tutorials relating to how to manage grants and perform administration of clinical research projects effectively.

26th March 2015 • comment

Managing clinical trials

by Barbara Farrell, Sara Kenyon, Haleema Shakur

Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field.

25th March 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

Discussing the study protocol

by D. Shamley, C. Heiberg, N. Kramer, B. Wright & C. Reddy
13th 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

ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs. 

18th December 2013 • 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

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

Requirements for high impact diagnostics in the developing world

by Mickey Urdea, Laura A. Penny, Stuart S. Olmsted, Maria Y. Giovanni, Peter Kaspar, Andrew Shepherd, Penny Wilson, Carol A. Dahl, Steven Buchsbaum, Gerry Moeller, Deborah C. Hay Burgess
9th August 2012 • comment
19th July 2012 • comment

Five seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.

30th November 2011 • 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

During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.

13th May 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

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

The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH

10th August 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

Laboratory data is crucial in ensuring subject safety and determining the effectiveness of an investigational medicinal product. Here are some issues to consider for clinical trial laboratories in resource-poor settings.

21st November 2009 • comment

Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!

21st November 2009 • comment

Project management ensures that the project does not veer off its intended pathway. This begins in planning, all the way through initiation to completion. Read the full article to learn more.

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

The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.

21st November 2009 • comment

Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.

21st November 2009 • comment

Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.

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