Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 661Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
Year : 2020  |  Volume : 11  |  Issue : 3  |  Page : 115-120

Challenges and opportunities for sponsors in conducting clinical trials during a pandemic

1 General Secretary, Indian Society for Clinical Research (ISCR), Mumbai, Maharashtra, India
2 Treasurer, Indian Society for Clinical Research (ISCR), Mumbai, Maharashtra, India

Correspondence Address:
Dr. Sanish Davis
C/O, Pfizer Limited, The Capital, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra (E), Mumbai - 400 051, Maharashtra
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.PICR_177_20

Rights and Permissions

The COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges have arisen, from country/ state lockdowns, site closures due to hospitals being taken over / sites being taken over for COVID-19 related care, travel limitations to sites for patients, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-scheduled visits and laboratory/diagnostic testing. This position paper from the perspective of Indian Society for Clinical Research (ISCR) aims to provide guidance to both frontline Clinical Research Professionals and sponsors on measures that can be taken while continuing ongoing clinical trial activities at site as well as resuming site level activities in the post COVID setting. Broad guidance is also given to sites and sponsors on use of Direct to Patient drug shipments, supplies and cold chain management and use of technologies to support enhanced remote functioning during and post COVID.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded714    
    Comments [Add]    
    Cited by others 5    

Recommend this journal