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The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa.
Trop Med Int Health. 2016 Aug; 21(8):1040-1048.TM

Abstract

OBJECTIVES

To explore the advantages and challenges of working with the Good Clinical Practice (GCP)-International Conference of Harmonization (ICH) E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa.

METHODS

We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal and thematically analysed the responses.

RESULTS

Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied. Only for informed consent did some clinical trial staff (one-third) perceive the guideline as insufficiently applicable. Specific challenges included meeting the requirements for written and individual consent, conditions for impartial witnesses for illiterates or legally acceptable representatives for children, guaranteeing voluntary participation and ensuring full understanding of the consent given. It was deemed important to have ICH-GCP compliance monitored by relevant ethics committees and regulatory authorities, without having guidelines applied overcautiously.

CONCLUSION

Clinical trial teams in sub-Saharan Africa perceived GCP as a helpful guideline, despite having been developed by northern organisations and despite the high administrative burden of implementing it. To mitigate consent challenges, we suggest adapting GCP and making use of the flexibility it offers.

Authors+Show Affiliations

Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.European Forum for Good Clinical Practice, Brussels, Belgium.Département de Sociologie, Université Cheikh Anta Diop de Dakar, Dakar, Senegal.Department of Sociology, University of Ghana, Legon, Ghana.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27260671

Citation

Vischer, N, et al. "The Good Clinical Practice Guideline and Its Interpretation - Perceptions of Clinical Trial Teams in sub-Saharan Africa." Tropical Medicine & International Health : TM & IH, vol. 21, no. 8, 2016, pp. 1040-1048.
Vischer N, Pfeiffer C, Joller A, et al. The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa. Trop Med Int Health. 2016;21(8):1040-1048.
Vischer, N., Pfeiffer, C., Joller, A., Klingmann, I., Ka, A., Kpormegbe, S. K., & Burri, C. (2016). The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa. Tropical Medicine & International Health : TM & IH, 21(8), 1040-1048. https://doi.org/10.1111/tmi.12734
Vischer N, et al. The Good Clinical Practice Guideline and Its Interpretation - Perceptions of Clinical Trial Teams in sub-Saharan Africa. Trop Med Int Health. 2016;21(8):1040-1048. PubMed PMID: 27260671.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa. AU - Vischer,N, AU - Pfeiffer,C, AU - Joller,A, AU - Klingmann,I, AU - Ka,A, AU - Kpormegbe,S K, AU - Burri,C, Y1 - 2016/06/28/ PY - 2016/6/5/entrez PY - 2016/6/5/pubmed PY - 2016/6/5/medline KW - Africa South of the Sahara KW - Afrique subsahararienne KW - Ensayos clínicos KW - bonnes pratiques cliniques KW - buenas prácticas clínicas KW - clinical trials KW - directive KW - essais cliniques KW - good clinical practice KW - guideline KW - guías KW - investigación cualitativa KW - qualitative research KW - recherche qualitative KW - África al sur del Sahara SP - 1040 EP - 1048 JF - Tropical medicine & international health : TM & IH JO - Trop. Med. Int. Health VL - 21 IS - 8 N2 - OBJECTIVES: To explore the advantages and challenges of working with the Good Clinical Practice (GCP)-International Conference of Harmonization (ICH) E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa. METHODS: We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal and thematically analysed the responses. RESULTS: Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied. Only for informed consent did some clinical trial staff (one-third) perceive the guideline as insufficiently applicable. Specific challenges included meeting the requirements for written and individual consent, conditions for impartial witnesses for illiterates or legally acceptable representatives for children, guaranteeing voluntary participation and ensuring full understanding of the consent given. It was deemed important to have ICH-GCP compliance monitored by relevant ethics committees and regulatory authorities, without having guidelines applied overcautiously. CONCLUSION: Clinical trial teams in sub-Saharan Africa perceived GCP as a helpful guideline, despite having been developed by northern organisations and despite the high administrative burden of implementing it. To mitigate consent challenges, we suggest adapting GCP and making use of the flexibility it offers. SN - 1365-3156 UR - https://www.unboundmedicine.com/medline/citation/27260671/The_Good_Clinical_Practice_guideline_and_its_interpretation___perceptions_of_clinical_trial_teams_in_sub_Saharan_Africa_ L2 - https://doi.org/10.1111/tmi.12734 DB - PRIME DP - Unbound Medicine ER -
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