title: "You can save time if…"-A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa.
abstract: BACKGROUND
  The costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams.
  
  
  METHODS
  We conducted sixty key informant interviews with clinical trial staff working in different positions in two clinical research centres in Kenya, Ghana, Burkina Faso and Senegal. The study covered English- and French-speaking, and Eastern and Western parts of Sub-Saharan Africa. We performed thematic analysis of the interview transcripts.
  
  
  RESULTS
  We found various internal factors associated with slowing down clinical trials; these were summarised into two broad themes, "planning" and "site organisation". These themes were consistently mentioned across positions and countries. "Planning" factors related to budget feasibility, clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning. "Site organisation" factors covered staff turnover, employment conditions, career paths, workload, delegation and management.
  
  
  CONCLUSIONS
  We found that internal factors slowing down clinical trials are of high importance to trial staff. Our data suggest that adequate and coherent planning, careful assessment of the setting, clear task allocation and management capacity strengthening may help to overcome the identified internal factors and allow clinical trials to proceed more efficiently.
authors.affiliation: Swiss Tropical and Public Health Institute, Department of Medicines Research, Basel, Switzerland.|University of Basel, Basel, Switzerland.
authors.forename: Nerina
authors.identifier: http://orcid.org/0000-0002-1030-6359
authors.initials: N
authors.lastname: Vischer
authors.affiliation: University of Basel, Basel, Switzerland.|Swiss Tropical and Public Health Institute, Department of Epidemiology and Public Health, Basel, Switzerland.
authors.forename: Constanze
authors.initials: C
authors.lastname: Pfeiffer
authors.affiliation: Swiss Tropical and Public Health Institute, Department of Medicines Research, Basel, Switzerland.|University of Basel, Basel, Switzerland.
authors.forename: Manuela
authors.initials: M
authors.lastname: Limacher
authors.affiliation: Swiss Tropical and Public Health Institute, Department of Medicines Research, Basel, Switzerland.|University of Basel, Basel, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Burri
mesh_terms: D017954:Africa South of the Sahara; D002017:Budgets; D002986:Clinical Trials as Topic / Q000191:economics / Q000458:organization & administration; D017598:Efficiency, Organizational; D006801:Humans; D009937:Organizational Objectives