Table 1

Challenges and opportunities in conducting evaluation studies of diagnostic tests during outbreak situations and identified opportunities for improvement

ChallengeOpportunities
Access to well-characterised clinical samples and reference materials
  • Identify mechanisms that can ensure timely ethical approval for collection, study and storage of specimens

  • Implement virtual biobanks and biobanking networks at regional and international levels

  • Create online catalogues of all available reference and control materials for specific diseases

Delays in importation and customs clearance processes
  • Ensure logistics teams are sufficiently staffed, well organised and experienced both at sponsor and study sites

  • Form relationships with national regulatory authorities

  • Develop regulatory/import processes that allow for rapid approval of permits and customs clearance during outbreak situations

Delays in drafting, approving and implementing study materials (eg, protocols, tools, contracts)
  • Develop ‘emergency mode’ procedures that can scale-up human resources and fast-track internal processes during health emergencies

  • Prepositioning of generic templates and adaptable systems that can be adopted rapidly during emergencies

  • Develop generic and adaptive protocols and study documents (eg, case report and informed consent forms) that have already been reviewed by key actors and require minimal input to be implemented in a timely manner

Limited or stretched resources at study sites during an outbreak affecting conduct of evaluation studies
  • Conduct clinical and laboratory assessments prior to any evaluation

  • Establish contingency funding to be triggered once an outbreak and need for test clinical evaluations is identified, to support human resource needs and purchasing of supplies, equipment and personal protective equipment

Hesitation to participate in a study due to stigma linked to the disease or fear of negative impact on employment
  • Integrate social sciences and engage local communities in the early stages of clinical study design

Constantly changing disease incidence and evolving testing strategies affecting ability to achieve study objectives
  • Establish network of partners with agreements already in place so evaluation plans can shift from one site to another

  • Ensure that import permits are already approved for all tests across all potential partner sites

  • Integrate adaptive clinical study designs during protocol development and study implementation

  • Ensure that tests are compatible with stored samples and universal media

Travel restrictions preventing in-person training and monitoring visits at study sites
  • Use of teleconferencing tools

  • Develop detailed assessment, training and monitoring tools (including online/remote options) and electronic data capture systems with audit trail

Variable quality of clinical trial data across sites
  • Implement network of study sites to ensure common practices are performed to a high standard

Difficulties ensuring independence of study conduct and data analysis
  • Apply well-defined and transparent scoring processes

  • Do not accept tests free of charge

  • Submit all data to open-access repositories, independently of the manufacturer’s opinion of the results