Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal-Reference-Cited by-同舟云学术

Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal

Published:2023-08 Issue:2 Volume:19 Page:
ISSN:2164-5515
Container-title:Human Vaccines & Immunotherapeutics
language:en
Short-container-title:Human Vaccines & Immunotherapeutics

Author:

Chapagain Ram Hari¹²^ORCID,Maharjan Jessica¹,Adhikari Santosh¹^ORCID,Thapa Prabhat¹,Kunwar Kshitij¹,Giri Bishnu Rath¹,Shrestha Nisha Jyoti¹²,Shrestha Anil Kumar¹²,Shrestha Sanjeet Kumar¹,Tamang Suresh Man¹,Cho Haeun³,Park Eun Lyeong³,Lee Jiyoung³,Lee Jinae³,Kim Deok Ryun³,Yang Jae Seung⁴,Saluja Tarun⁵,Wartel Anh⁶,Lynch Julia⁷,Song Katerina Rok⁵^ORCID

Affiliation:

1. OCV-S Trial Site, Kanti Children’s Hospital, Kathmandu, Nepal

2. Department of Paediatrics, National Academy of Medical Sciences (NAMS), Kathmandu, Nepal

3. Biostatistics & Data Management Unit, International Vaccine Institute (IVI), Seoul, Korea

4. Science Unit, International Vaccine Institute (IVI), Seoul, Korea

5. Clinical, Assessment, Regulatory, Evaluation (CARE) Unit, International Vaccine Institute (IVI), Seoul, Korea

6. Europe Regional Office Director, International Vaccine Institute (IVI), Seoul, Korea

7. Cholera Program Director, International Vaccine Institute (IVI), Seoul, Korea

Funder

Bill & Melinda Gates Foundation

Publisher

Informa UK Limited

Subject

Pharmacology,Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/21645515.2023.2239680

Reference16 articles.

1. World Health Organization. WHO-director general’s opening at the media briefing on COVID-19. 2020 Mar 11 [accessed 2022 Jan 10]. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—11-march-2020.

2. World Health Organisation. Pneumonia of unknown cause–China. 2020 Jan 5 [accessed 2022 Jan 10]. https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en.

3. Managing clinical trials during COVID-19: experience from a clinical research facility

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

5. Ethical and Scientific Implications of the Globalization of Clinical Research