Owusu Sekyere Solomon, Škrnjug-Yudov Ivana, Pinz Alexander, Meyer Heidi, Conrad Christoph
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
RegTrain-VaccTrain of the Global Health Protection Programme (GHPP), Paul-Ehrlich-Institut, Langen, Germany.
Front Med (Lausanne). 2022 Mar 2;9:772605. doi: 10.3389/fmed.2022.772605. eCollection 2022.
Development of safe and efficacious medicines in many sub-Sahara African countries remains hampered due to fragmented health research infrastructure and ineffective regulatory oversight. To boost the latter in the area of Clinical Trials (CT) Oversight (CTO), many international programs and Regional Centers for Regulatory Excellence (RCORE) initiatives offer various trainings to help strengthen human resource capacity. Here, we aimed at evaluating the training outcomes (at home-institution level) of sponsored fellows for one of such capacity strengthening interventions; a measure that is less often reported and thus remains poorly understood.
The Global Health Protection Programme's VaccTrain project sponsored nine regulatory staff from eight National Medicines Regulatory Authorities (NMRAs) in sub-Saharan Africa for the RCORE CT Training Fellowship by FDA Ghana in a particular year. Using a systematized evaluation framework based on the theory of change, we assessed the individual- and NMRA-level achievement of pre-defined training outcomes. For this purpose, data was collected at pre-training and at short- and long-term evaluation time-points using a survey instrument.
At pre-training, our data revealed existence of differential expectations and orientations among the training participants, thus providing an early indication of potential distinctive patterns in achievement of desired training outcomes. In a short-term post-training follow-up evaluation, a two-group clustering of fellows based on the achievement of training outcomes where only one group (representing 44%) reported achievement of CTO-related outcomes was observed. At this time-point, achievement of training outcomes was associated with the vibrancy of CT activity and existence of a comprehensive technical structure for CTO. In a further long-term follow-up evaluation, our data revealed a successful achievement of CTO-related individual- and/or institutional-level outcomes in all but one fellow. Here again, availability of a robust technical structure for CTO (and perhaps fellow affiliation/selection)-but not CT vibrancy-showed a trend of temporal association with achievement of training outcomes.
Given the pivotal role operational structures of international standards at home institutions play in translating training-acquired knowledge into measurable CTO-related outcomes, we encourage that capacity strengthening projects aimed at achieving health-related targets of Sustainable Development Goals adopt an approach built on this foundation.
撒哈拉以南非洲的许多国家，由于卫生研究基础设施分散以及监管监督不力，安全有效的药物研发仍然受到阻碍。为了加强临床试验监督（CTO）领域的监管，许多国际项目和卓越监管区域中心（RCORE）倡议提供了各种培训，以帮助加强人力资源能力。在此，我们旨在评估此类能力加强干预措施之一的资助学员的培训成果（在国内机构层面）；这一措施较少被报道，因此人们对其了解甚少。
全球卫生保护计划的VaccTrain项目在某一年赞助了来自撒哈拉以南非洲八个国家药品监管机构（NMRA）的九名监管人员参加由加纳食品药品监督管理局举办的RCORE CT培训奖学金项目。我们使用基于变革理论的系统化评估框架，评估了预先定义的培训成果在个人和NMRA层面的达成情况。为此，我们在培训前以及短期和长期评估时间点使用调查问卷收集数据。
在培训前，我们的数据显示培训参与者之间存在不同的期望和倾向，从而为实现预期培训成果的潜在独特模式提供了早期迹象。在短期培训后随访评估中，根据培训成果的达成情况对学员进行了两组聚类，其中只有一组（占44%）报告实现了与CTO相关的成果。在这个时间点，培训成果的达成与CT活动的活力以及CTO综合技术结构的存在相关。在进一步的长期随访评估中，我们的数据显示，除一名学员外，所有学员在个人和/或机构层面均成功实现了与CTO相关的成果。同样，CTO强大技术结构的可用性（可能还有学员所属机构/选拔情况）——而非CT活动的活力——显示出与培训成果达成情况存在时间上的关联趋势。
鉴于国内机构的国际标准运营结构在将培训获得的知识转化为可衡量的与CTO相关的成果方面发挥着关键作用，我们鼓励旨在实现可持续发展目标中与健康相关目标的能力加强项目采用基于此基础的方法。
