Innovative Approaches to Clinical Data Management in Resource Limited Settings Using Open-Source Technologies

نویسندگان

  • Raymond Omollo
  • Michael Ochieng
  • Brian Mutinda
  • Truphosa Omollo
  • Rhoda Owiti
  • Seth Okeyo
  • Monique Wasunna
  • Tansy Edwards
چکیده

The primary objective of clinical data management (CDM) is to provide highquality, reliable data for reporting randomized controlled trials (RCTs) in line with good clinical practice (GCP) requirements. For treatment trials of neglected tropical diseases (NTDs) in endemic countries, CDM systems need to be efficient and affordable. Challenges include poor infrastructure, license costs associated with GCP-compliant software, and limited human resources to provide the required expertise. We argue that high-quality CDM for NTDs can be achieved and that challenges can be overcome through the use of readily available open-access tools. The Drugs for Neglected Diseases initiative (DNDi) [1,2] sponsors several RCTs of treatments for visceral leishmaniasis (VL) in eastern Africa, working with regional partners through the Leishmaniasis East Africa Platform (LEAP). These trials are conducted according to GCP standards to ensure internal and external validity, with CDM conducted by the authors at the Data Centre (DC) based at DNDi Africa in Nairobi. Choice of proprietary or open-source tools is dependent largely on budget and user experience, with tools used independently or in combination. We have been working to overcome two main challenges:

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عنوان ژورنال:

دوره 8  شماره 

صفحات  -

تاریخ انتشار 2014