This month we bid farewell to three fellows from MSD who joined DNDi in July as part of the MSD Richard T. Clark Fellowship for Global Health. This three-month, pro bono programme is designed to leverage the skills and talents of MSD employees to support the efforts of non-governmental organizations working to improve access to health, strengthen health systems, and build organizational capabilities.
At DNDi, Gina Bergman, Elias Dorfman, and Karyn O’Flaherty were tasked with developing a training programme and accompanying materials to support trial conduct at DNDi sites in resource-constrained settings to facilitate generation of high-quality data suitable for the drug registration process.
With continuous expansion to new clinical sites, including those with limited prior research experience, DNDi identified the need to develop a more formalized training programme and materials to equip investigators, DNDi clinical staff, and site staff with the skills and knowledge needed to carry out clinical trials safely and effectively.
Tasked with kicking off this project, the fellows first initiated a scoping exercise that began several weeks before the official start of their fellowship. ‘Speaking to the staff at the trial sites, we soon realized the challenges they face,’ said Dorfman. ‘The challenges of conducting clinical trials in resource-constrained settings are very different to those you might expect in Europe or the US,’ commented Bergman. Dorfman added: ‘As a result, we adapted our approach from developing training materials only on regulatory compliance. We also worked to incorporate guiding principles to enable clinical trial site staff to manage unforeseeable situations within the framework of good clinical practice.’
Working with DNDi staff in Geneva, India, the Democratic Republic of the Congo, Kenya, Brazil, and Malaysia, and with clinical trial sites in India and the Democratic Republic of the Congo, Bergman, O’Flaherty, and Dorfman worked to consolidate the training programmes and material that already existed and to identify gaps. They then built a comprehensive training programme that will serve as a strong foundation on which to build.
The fellows were grateful to have ample time to dedicate, able to get into the project conceptually and structurally and to work alongside DNDi teams to design new training programmes for trial site staff. ‘We appreciate and respect the amount of work the DNDi colleagues on the project have and we have been very impressed by the teamwork, collaboration, and structure at DNDi,’ said O’Flaherty. ‘The passion shows,’ added Dorfman.
Asked to sum up their impressions of the experience, Dorfman said ‘I was struck by how generous the people we worked with at DNDi were in sharing their time, experience, knowledge, and expertise with us, even though they are very busy.’ Bergman commented: ‘We felt that what we were putting in was really valued by the people we worked with; they were so appreciative of our efforts and that was such a good feeling.’
Now that they have completed their assignment, the fellows agreed that while they have achieved their objectives, they hope that the work they have done can be taken even further in the months and years to come. ‘There is so much more we would have liked to do, but I hope that we leave behind useful and practical resources to help DNDi with their mission to expand their research footprint, bringing new sites on board and continuing to do the work that they do – good research,’ said O’Flaherty. Bergman added that she can already see opportunities for other fellows to build on, continuing the work that her cohort have started. ‘We hope we’ve carved a path for others to follow,’ she said. Dorfman added that he hoped they had created material that can be used as-is, but that will also allow people to create new content in the same vein. ‘We hope that what we have developed will be helpful in training staff conducting all phases of clinical trials, particularly in terms of more foundational work relating to good clinical practice in challenging circumstances,’ he said.
Traditionally, fellows would spend time in-country; however, uncertainty due to the COVID-19 pandemic meant that this year was entirely virtual. But Dorfman, Bergman, and O’Flaherty return to MSD with a common aspiration: to one day visit the sites they worked with in person. ‘We hope to travel to some of the sites we worked with to see how the project has turned out, so that’s definitely on the bucket list,’ said O’Flaherty. Should they manage to achieve this, they are assured to be given a warm welcome by all who had the privilege of working with them during their time with DNDi.
Photo credit: Kenny Mbala-DNDi, Maneesh Agnihotri-DNDi