Perspectives in Clinical Research

REVIEW ARTICLE
Year
: 2015  |  Volume : 6  |  Issue : 2  |  Page : 77--81

Phase I (first-in-man) prophylactic vaccine«SQ»s clinical trials: Selecting a clinical trial site


Shantanu Mehta, Vishal Goyal, Kavita Singh 
 Clinical Development, Malaria Vaccine Development Program, International Centre for Genetic Engineering and Biotechnology Campus, New Delhi, India

Correspondence Address:
Dr. Shantanu Mehta
Associate Director, Clinical Development, Malaria Vaccine Development Program International Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi - 110 067
India

An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving.In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine.


How to cite this article:
Mehta S, Goyal V, Singh K. Phase I (first-in-man) prophylactic vaccine's clinical trials: Selecting a clinical trial site.Perspect Clin Res 2015;6:77-81


How to cite this URL:
Mehta S, Goyal V, Singh K. Phase I (first-in-man) prophylactic vaccine's clinical trials: Selecting a clinical trial site. Perspect Clin Res [serial online] 2015 [cited 2019 Oct 20 ];6:77-81
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2015;volume=6;issue=2;spage=77;epage=81;aulast=Mehta;type=0