Challenges and Lessons From Conducting A Paediatric Clinical Trial in Sub-Saharan Africa: The Case of the Praziquantel Oral Dispersible Tablets Phase II Study in Côte d'Ivoire

Adv Parasitol. 2019:103:75-89. doi: 10.1016/bs.apar.2018.09.002. Epub 2018 Oct 22.

Abstract

The importance of implementing paediatric clinical trials for neglected tropical diseases (NTDs) in compliance with the Good Clinical Practices of the International Conference of Harmonisation (ICH-GCP) and other applicable regulatory and ethics guidelines is increasingly being recognised as an essential pathway to provide safe and effective medicines for millions of untreated children living in sub-Saharan Africa (SSA). This paper describes the learnings and challenges faced by the Pediatric Praziquantel Consortium team during the implementation of an industry-sponsored Phase II clinical study in pre-school-aged children infected with schistosomiasis, conducted in remote rural settings in Côte d'Ivoire. The importance of close interactions with the ethics committee, the regulatory and administrative authorities and the rural communities are highlighted. The difficulties faced included obtaining a valid informed consent from the child's parent or guardian, the collection of blood samples from children during the study while respecting cultural beliefs as well as the weak medical research infrastructure. The paper illustrates how a public-private collaborative partnership can promote capacity-building and high-quality NTD paediatric clinical research in SSA.

Keywords: Bilharzia; Clinical trial; Informed consent; NTDs; Paediatric; Praziquantel; Pre-school-aged children; Schistosomiasis; Sub-saharan Africa; Tropical diseases.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Anthelmintics / administration & dosage
  • Child, Preschool
  • Clinical Trials, Phase II as Topic / ethics
  • Clinical Trials, Phase II as Topic / standards*
  • Cote d'Ivoire
  • Humans
  • Informed Consent
  • Praziquantel / administration & dosage*
  • Rural Population
  • Schistosomiasis / drug therapy*
  • Tablets / administration & dosage

Substances

  • Anthelmintics
  • Tablets
  • Praziquantel