Quality assurance of clinical research is critical to ensure meaningful results in compliance with universal ethical standards. Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) codes have been developed as tools to ensure data integrity and ethical study conduct. However, these codes are often considered beyond reach for resource constrained settings. A recently published collection in PLOS Neglected Tropical Diseases shares experiences, lessons learned and practical tools developed during clinical research on neglected tropical diseases in Africa and Asia.
The Good Clinical Practice collection was published as part of a collaborative project sponsored by the NIDIAG Consortium, a European research network and organized by Dr. Marleen Boelaert of the Institute of Tropical Medicine in Belgium. The collection features seven articles covering a range of topics relevant to treating neglected tropical diseases (NTDS) in clinical settings including designing, setting up, implementing, and evaluating clinical studies.
The articles in the collection address many of the challenges specific to NTDs research, as well as infrastructure, culture, social-ecological systems, conflicting health policies, and ethics requirements. The articles propose solutions, provide guidelines and best practices, as well as resources for developing and implementing standard operating procedures for conducting clinical research in low resource settings.
Approximately 1.2 billion people are affected by NTDs globally, particularly among impoverished populations and in conflict zones. Moreover, NTDs can hinder economic productivity and diminish quality of life. One of the major obstacles in the clinical management of NTDs is the lack of robust health services in disease endemic countries. However, NIDIAG Consortium member and author Marleen Boelaert is hopeful that "this article collection will stimulate others working on clinical-diagnostic issues of NTDs to further improve patient management and population-based control and elimination."
Please contact email@example.com if you would like more information about our content and specific topics of interest.
Collection URL: http://collections.
Funding: This work is part of the NIDIAG European research network (Collaborative Project), supported by the European Union's Seventh Framework Programme for research, technological development, and demonstration under grant agreement no. 260260. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
Ravinetto R, Alirol E, Mahendradhata Y, Rijal S, Lutumba P, Sacko M, et al. (2016) Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices.
Barbé B, Verdonck K, El-Safi S, Khanal B, Teav S, Lilo Kalo J-R, et al. (2016) Rapid Diagnostic Tests for Neglected Infectious Diseases: Case Study Highlights Need for Customer Awareness and Postmarket Surveillance.
El-Safi S, Chappuis F, Boelaert M (2016) The Challenges of Conducting Clinical Research on Neglected Tropical Diseases in Remote Endemic Areas in Sudan.
Alirol E, Horie NS, Barbé B, Lejon V, Verdonck K, Gillet P, et al. (2016) Diagnosis of Persistent Fever in the Tropics: Set of Standard Operating Procedures Used in the NIDIAG Febrile Syndrome Study.
Becker SL, Yap P, Horié NS, Alirol E, Barbé B, Bhatta NK, et al. (2016) Experiences and Lessons from a Multicountry NIDIAG Study on Persistent Digestive Disorders in the Tropics.
Boelaert M, The NIDIAG Consortium (2016) Clinical Research on Neglected Tropical Diseases: Challenges and Solutions.
Barbé B, Verdonck K, Mukendi D, Lejon V, Lilo Kalo J-R, Alirol E, et al. (2016) The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices.