Introducing Global Health Trials - your online specialist professional network Liam Boggs The Global Health Network University of Oxford Centre for Clinical Vaccinology & Tropical Medicine

Who we are…. Global Health Trials is a free and open access collaborative programme to support clinical trials in developing countries. The Aim…. To establish a mechanism for everyone working on clinical trials to have access to guidance, tools, resources, training – and each other What we have achieved… The site was released in May There are currently 35,000 unique visitors from over 140 developing countries using this platform. Over 20% of these have visited the site over 50 times!

 There is far too limited access to clinical research skills training in developing countries There are initiatives providing clinical trial training Few trial steps, processes, methods or issues are truly specific to one disease  Currently there is not adequate skills and knowledge training in LMIC There is a need for more disease management trials to address local questions Global Health Trials works by knowledge and methods sharing across disease areas, staff roles and geographic regions Why is this needed and how does it work?

Features of Global Health Trials Member Profile and Connect Together system Discussion forums and blogs Guidance articles, tools and resources Regional faculties E-learning Professional membership scheme Bookmarks, events and opportunities Why we think it is working All regions, all staff roles – ALL DISEASE AREAS Clear, clean and professional-looking space designed around the concept of encouraging a community Neutral, democratic – not belonging or located in any one institution; modeled on the Cochrane Group

Groups Topics Discussion Community Discussion Groups

Blogs are also very popular and help research groups find help and support

Guidance articles are a core element. These provide explanatory notes alongside all the necessary tools such as templates and examples

Most steps, processes and issues are the same Cross cutting ‘how-to’ skills training for all roles of staff, all disease areas and all regions Simple concept of taking good face to face courses and adapting them into e-learning material Sharing training material e-Learning Centre Our philosophy is quite simple…. - Take these great training resources you have all developed and share them by creating e-learning courses!

e-Learning Short Courses 1.Introduction to Clinical Research 2.ICH Good Clinical Practice Course 3.Setting the Research Question 4.The Research Protocol: Part one 5.The Research Protocol: Part two 6.Data Safety Monitoring Boards for Clinical Trials 7.Introduction to Consent 8.Introduction to Data Management For Clinical Research Studies 9.Introduction to Collecting and Reporting Adverse Events in Clinical Research 1.Introduction to Clinical Research 2.ICH Good Clinical Practice Course 3.Setting the Research Question 4.The Research Protocol: Part one 5.The Research Protocol: Part two 6.Data Safety Monitoring Boards for Clinical Trials 7.Introduction to Consent 8.Introduction to Data Management For Clinical Research Studies 9.Introduction to Collecting and Reporting Adverse Events in Clinical Research

e-Learning Short Courses Innocent Mbuagbaw

e-Seminars are available in both audio (MP3) and video (MP4) and are delivered by experienced clinical trial researchers

A f ormal record of professional skills and experience is common in other careers In Europe and the US medical research is a recognised professional career In developing countries this often goes unrecognised and unrewarded All types of clinical research studies need a range of staff in order to produce an ethical and valid study. All staff involved need to be valued for their role and responsibilities Guidance and training to develop skills and careers We need to better support, develop and retain trial staff Career Development Scheme – Why is this needed?

The Professional Membership Scheme Bill & Melinda Gates funded partnership between GHT & WHO/UN- TDR Professional membership for all levels of clinical research staff. This scheme increases professional recognition and tracks development It is free, comprehensive, validated and high quality Good for sites – provides a mechanism for staff review Good for individuals – provides own record and highly motivational Bill & Melinda Gates funded partnership between GHT & WHO/UN- TDR Professional membership for all levels of clinical research staff. This scheme increases professional recognition and tracks development It is free, comprehensive, validated and high quality Good for sites – provides a mechanism for staff review Good for individuals – provides own record and highly motivational

5. CPD as part of daily work 4. Moderation 3. Fill in other CPD Points 2. Fill in Core Competencies 1. Build CV Steps involved in awarding a professional membership

Features of the Professional Membership Scheme: Creates awareness that this is a valid career path with wide opportunities Provides feedback and recognition Allows researchers to identify appropriate and targeted training opportunities Audited and moderated (annual review) for quality and validity Information very secure Professional looking CV and training record. Helps research study leaders and institutions support, manage and develop their staff

GlobalHealthTrials.org metrics September 2012 Members3252 Visits74,634 Unique Visits35,461 Number of different developing countries of origin of visits140 Returning Visits %53% Job roles of members Professional Memberships Scheme members: 170 Most visits from LMIC Global Health Trials is engaging and supporting researchers E-Learning Courses Taken: 1341

The Trial Initiation Participatory Process Map

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We could all help each other by sharing our successes Solutions to most trial challenges can be applied globally We need to increase access to training and knowledge We need to be better at supporting ALL our trial staff Please register – please get involved! Acknowlegements: Jeremy Farrar, Rosanna Peeling, Kevin Marsh, Tracy Chantler, Sam Franzen, Tamzin Furtado, Nicola McHugh, Francois Van Loggerenburg, Trudie Lang The Global Health Network is funded by The Bill and Melinda Gates Foundation To summarise: