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5. Optional Modules
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Intervention trials
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INDEPTH has been striving to build on and strengthen the proven capability and resource of its
demographic and health surveillance sites to address the question of how population-based
surveillance can be used for interventions that address the severe social and health challenges in
the developing world. INDEPTH has therefore established a platform that aims at strengthening the
scientific and managerial capability in member sites to conduct clinical research based on good
clinical practice (GCP), good laboratory practice (GLP) and good data practice (GDP). Compliance
with these standards provides public assurance that the rights, safety and well- being of trial
subjects are protected and that the clinical trial data are credible.
For good trials practice, a clinical research centre in a developing country must have the following
characteristics:
- Appropriate epidemiology;
- Local ownership at all levels (country, district, local);
- Strong ties to other institutions and support from government;
- Governance that is functional (not bureaucratic) and attracts donors;
- Accountability – fiduciary and programme;
- Institutional Review Board;
- Logistics - accessibility, communication routes, living conditions (e.g. schools);
- Leadership;
- Strategic management – Principal investigators able to select among projects, create a
portfolio of activities and sustain the site independent of a single funder;
- Ability to forge alliances and show accountability to sponsors/funders; and Training, service
provision, and research are all mutually supportive and integral to success.
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