TY - JOUR
T1 - Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings
T2 - Experience from Nepal
AU - Saluja, Tarun
AU - Giri, Bishnu Rath
AU - Chaudhary, Shipra
AU - Tamrakar, Dipesh
AU - Kanodia, Piush
AU - Palkar, Sonali
AU - Vemula, Sridhar
AU - Chinaworapong, Suchada
AU - Kim, Bomi
AU - Gupta, Birendra Prasad
AU - Kyoung Jo, Sue
AU - Aspinall, Sanet
AU - Rai, Ganesh Kumar
AU - Steele, Duncan
AU - Kim, Jerome H.
AU - Wartel, T. Anh
AU - Sahastrabuddhe, Sushant
N1 - Publisher Copyright:
© 2021 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2021
Y1 - 2021
N2 - Clinical trials are complicated, time-consuming and costly. From the initial screening, informed consent and recruitment of the participants’ to study completion, the sponsor must undertake a wide array of complex and closely monitored operations, complying with international standards for human subject research and local requirements. Conducting these studies in an underdeveloped country, with limited resources, infrastructure, and experience with regulated clinical trials adds to this complexity. The initial site selection, set up and preparatory activities for the clinical trial are crucial to minimizing the risks to both participants and to successful completion during the subsequent study execution. In this paper, we describe the experience and lessons learned of building clinical trial site capacity in terms of infrastructure and human resource development for a Phase III vaccine clinical trial. We believe that sharing the experience of setting up a clinical trial in a resource-limited country will enable other entities contemplating clinical research in these countries, to prepare and plan ahead, to minimize the impact of barriers, and to contribute to bringing more studies to the countries where people live with the burden of vaccine-preventable, poverty-associated diseases.
AB - Clinical trials are complicated, time-consuming and costly. From the initial screening, informed consent and recruitment of the participants’ to study completion, the sponsor must undertake a wide array of complex and closely monitored operations, complying with international standards for human subject research and local requirements. Conducting these studies in an underdeveloped country, with limited resources, infrastructure, and experience with regulated clinical trials adds to this complexity. The initial site selection, set up and preparatory activities for the clinical trial are crucial to minimizing the risks to both participants and to successful completion during the subsequent study execution. In this paper, we describe the experience and lessons learned of building clinical trial site capacity in terms of infrastructure and human resource development for a Phase III vaccine clinical trial. We believe that sharing the experience of setting up a clinical trial in a resource-limited country will enable other entities contemplating clinical research in these countries, to prepare and plan ahead, to minimize the impact of barriers, and to contribute to bringing more studies to the countries where people live with the burden of vaccine-preventable, poverty-associated diseases.
KW - Capacity building
KW - clinical trial
KW - phase III
KW - resource-limited settings
KW - vaccine trial
UR - http://www.scopus.com/inward/record.url?scp=85100266440&partnerID=8YFLogxK
U2 - 10.1080/21645515.2020.1855955
DO - 10.1080/21645515.2020.1855955
M3 - Article
C2 - 33524278
AN - SCOPUS:85100266440
SN - 2164-5515
VL - 17
SP - 2149
EP - 2157
JO - Human Vaccines and Immunotherapeutics
JF - Human Vaccines and Immunotherapeutics
IS - 7
ER -