Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal.


Saluja T(1), Giri BR(2), Chaudhary S(3), Tamrakar D(4), Kanodia P(5), Palkar S(6), Vemula S(1), Chinaworapong S(1), Kim B(1), Gupta BP(1), Kyoung Jo S(1), Aspinall S(7), Rai GK(2), Steele D(8), Kim JH(1), Wartel TA(1), Sahastrabuddhe S(1).
Author information:
(1)International Vaccine Institute, Seoul, Republic of Korea.
(2)Kanti Children's Hospital, Kathmandu, Nepal.
(3)B P Koirala Institute of Health Sciences, Dharan, Nepal.
(4)Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.
(5)Nepalgunj Medical College, Nepalgunj, Nepal.
(6)Bharti Hospital, Pune, India.
(7)Ardent Consulting
(Pty) Ltd, South Africa.
(8)Bill & Melinda Gates Foundation, Seattle, USA.


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.