Vischer Nerina, Pfeiffer Constanze, Kealy Jennifer, Burri Christian
Department of Medicines Research, Swiss Tropical and Public Health Institute, Socinstrasse 57, 4051 Basel, Switzerland.
University of Basel, Petersplatz 1, 4003 Basel, Switzerland.
Glob Health Res Policy. 2017 Apr 7;2:11. doi: 10.1186/s41256-017-0031-1. eCollection 2017.
The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa.
We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews.
Protocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures.
Our data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol suitability enhancing measures, planners must allocate enough time for trial preparation and solicit feedback and information on context at an early stage. Such prospective planning would increase implementability, efficiency and quality of trials in the long run.
试验方案是临床试验最重要的文件，它不仅描述了研究的设计和方法，还涵盖了所有实际方面。方案的适用性对试验的执行和结果有直接影响。然而，在试验实践和研究中，适用性很少得到关注。我们研究的目的是调查方案的适用性，并确定撒哈拉以南非洲地区试验中提高适用性的措施。
我们采用了探索性混合方法设计。首先，我们采访了加纳、布基纳法索和塞内加尔不同组织层面的36名试验工作人员。其次，我们对撒哈拉以南非洲地区的试验工作人员进行了在线调查，以根据访谈中提炼出的主要主题调查试验方案的适用性。
方案适用性在对试验工作人员的访谈中成为一个突出的话题，因其缺乏清晰度、可实施性以及对试验参与者、劳动力和现有基础设施的适应性而受到批评。定性和定量调查都确定，让当地现场工作人员参与方案制定是提高方案适用性最有效的方法。仔细评估当地情况、能力和文化，以及确保工作人员理解方案也被认为是有帮助的措施。
我们的数据表明，通过提前与试验工作人员讨论和审查方案，可以提高方案的适用性。让有实际操作经验的工作人员参与将最为有用。对于多中心试验，我们建议从预计招募率最高的每个站点至少选派一名试验工作人员参与方案制定。在研究开始前仔细评估情况对于确保方案适用性是必不可少的，尤其应关注现有的劳动力和基础设施，以及试验参与者的需求和可得性。为了采取提高方案适用性的措施，规划者必须为试验准备分配足够的时间，并在早期征求关于情况的反馈和信息。从长远来看，这种前瞻性规划将提高试验的可实施性、效率和质量。
