Highlights from monitor 2
Emily Nyanzi-Kabuye from Uganda, reported on how the East African Consortium for Clinical Research (EACCR-1 and EACCR-2) funded by EDCTP2 has trained 100 scientists and research managers, four laboratories have been accredited. Of the three post-docs two became principle investigators. EACCR-2 has greatly benefited from EACCR-1 as this facilitates in the retention of staff.
Elizabeth Rapa from the Global Health Network, presented on their platform which supports researchers do their work. Using the Research Competency Wheel can help identify the gaps that need to be addressed and supported by a highly robust team of experts for site preparedness.
Patience Oduor from Kenya, showed how EACCR-2 was able to audit the Siaya county referral hospital in order to identify the gaps to be addressed for this site to undertake clinical trials. The hospital has an Institutional Review Board but its members had no training in bioethics. Moreover, there were acute staff shortages; reagent stock-outs; no GCP or GCLP training; faulty laboratory equipment; insufficient IT support and internet delays; no library and no data analysis nor statistical expertise nor financial management systems. EACCR-2, therefore, can enable this hospital to address all this and develop site preparedness.
Angela Lazarova’s talk (based on work done at the Swiss Tropical and Public Health Institute) was interesting as she pointed out that there is no shared definition of clinical trial (CT) quality. Upon interviewing stakeholders (principal investigators; sponsors and monitors) there were two elements of quality which were considered important: research integrity and patient protection. Different stakeholder groups play a potential role in CT quality perception and aspects of certain themes had the potential to be setting specific. These CT quality themes can be used as a basic structure for a CT quality concept.