Clinical Trials in East Africa: a One-Day Skills Sharing Workshop Report

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REPORT ON A ONE-DAY SKILL SHARING WORKSHOP FOR IMPROVED CLINICAL TRIALS & RESEARCH IN EAST AFRICA HELD AT THE SANCTUM HOTEL IN ENTEBBE, UGANDA (14TH FEBRUARY 2013)

Authors: George Miiro, Emily Nyanzi
Date: 15th February 2013

n.b. The slides from the workshops, and the picture taken outside the venue, can be downloaded from the right hand side of the screen.

Preamble
UVRI/MRC in partnership with the EACCR secretariat and the Global Health Network organized a one-day workshop in Entebbe to facilitate the sharing of knowledge and experience in order to promote best practices in support of improved clinical trials and health research in Uganda and East Africa.

This aimed at opening more opportunities for promising and prospective young professionals and health practitioners to interact with senior African researchers to pursue fruitful professional career pathways in health research. Such interactions would be across disease-specific specializations, disciplines, institutions, borders and level of seniority.

It was attended by 51 participants from: UVRI, its on-campus partners, Makerere College of Health Sciences, Global Health-Uganda, Amsterdam Institute for Global Health & Development, International Biometric Society-Uganda, MUTHI, KEMRI, Joint Clinical Research Center and Bwindi Community Hospital. Conventional medicine practitioners interacted with traditional medicine practitioners; basic scientists with clinicians, data professionals and laboratory technicians.

Six of the 7 presentations as per the workshop program were discussed. The 7th presentation is available as a soft copy to be shared with participants as the UVRI Director was not able to make it due to another concurrent important engagement.

Workshop deliberations

George Miiro introduced the purpose of this workshop i.e facilitating the sharing of knowledge & experiences in support of best practices for improved conduct of clinical trials and research, across disease specializations, disciplines and institutions. He gave a background to this workshop sponsored by the Global Health Network. George shared the benefits of using the Global Health Trials free online resources e.g SiteFinder, the Research Nurses’ network, professional membership scheme and numerous research tool templates. He introduced the EACCR project coordinator.

Prof. Kaleebu, the EACCR project Coordinator, gave his opening remarks. He then gave a talk on the UVRI profile on behalf of the UVRI Director, who was unable to make it to the workshop. He went ahead to give his oral presentation on the latest HIV vaccine development, research and prevention research. He mentioned insights from the Thai vaccine trial which revealed IgA as a correlate of HIV-infection and Ig G as correlate of HIV protection. It is postulated that IgA may bind unto sites on the v1/v2 loop thereby blocking the Ig G from binding to the same sites. Ig G use the antibody dependent cytotoxicity mechanism instead of viral neutralization. He briefed participants that 36 HIV vaccine candidates are in phase 1 trials and 1 candidate in phase 2b efficacy trial. There is a planned phase 1 trial on passive immunotherapy for infants born to HIV-infected mothers through the MRC/UVRI research unit in Uganda with VRC01.

Dr Merlin Willcox, a General Practitioner and lecturer at the University of Oxford, shared his experience in traditional medicine research through Multidisciplinary University in Traditional Health Initiative (MUTHI). He gave the rationale for promoting traditional medicine through reverse pharmacology approach instead of the conventional drug development process. While in Mali, he conducted a Retrospective Treatment Outcome (RTO) study, where the team compared the effectiveness of the ACT and Argemone Mexicana (a phytomedicine) in malaria parasite clearance. The ensuing discussions urged further opportunities for collaborative research between the traditional medicine practitioners and conventional medicine practitioners.

Elizabeth Ayou from KEMRI-CDC, Kisumu shared benefits and experiences from a regional pool of experienced monitors of clinical trials in East Africa involved in the innovative reciprocal monitoring scheme. Discussions explored further partnership with other clinical monitors of the INTERACT team affiliated with the Amsterdam Institute for Global Health and Development.

Data professionals (Jonathan and Dan Kajungu) presented the potential benefits for the existing and potential researchers to be involved in the Data Safety & Monitoring Boards as well as Data Professionals’ networks. Professional networks enable sharing of best practices, experiences and expertise in use of various software for data management, randomization and project management.

Dr. Kiwanuka, with prior vast experience in setting up a clinical trial facility since 1994, narrated his experience and factors necessary for establishing a clinical trial facility. One has to carefully navigate the ‘interdisciplinary politics’ of health research actors, secure stakeholder-wide engagement plus co-ownership at on-set and he must be so determined, focused and persistent. Situational analysis/gap assessment must be done while engaging institutional authorities. There should be 1-2 pager concept note on this initiative with a shared and aligned vision, mission, mandate, rationale, potential benefits and possible sources of funding. This plan must be marketed rigorously and widely to secure wide stakeholder buy-in. The implementation must strive to adhere to the set and shared plan as much as possible. The new facility should be launched by the institutional authorities. A sustainability strategy should be built in as well, including a succession plan. The ensuing discussion emphasized the need to also engage representatives of the pharmaceutical industry who have the potential health products.

Conclusion
The workshop was held successfully as fact sheets on the Global Health Network profile, tools, resources and EACCR were shared with participants. The slides available will be shared electronically with the participants. The material and recommendations generated from this workshop will be available on the EACCR and Global Health Network websites.