spacer
home > ict > summer 2020 > preserving trial integrity during a pandemic
PUBLICATIONS
International Clinical Trials

Preserving Trial Integrity During a Pandemic


The pharmaceutical industry is being impacted by the COVID-19 pandemic in ways not seen before. From decreased recruitment rates due to enforced social distancing policies, to a complete halt in drug development programmes as companies project their budgets. Trials are not being run as usual, and the pandemic’s effect on ongoing clinical trials may threaten scientific accuracy and regulatory compliance. However, with the correct changes and statistical methodologies in place, a study’s integrity can be preserved.

Sample Size: Are We Good or Not?

The right sample size ensures a successful study while balancing costs and minimising the number of patients undergoing potentially invasive procedures. We might think of continuing as planned until normality is restored, however, the costs of running a study that doesn’t deliver results in the agreed timelines can be overwhelming for major pharma companies, and a killer for smaller biotech companies.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
About the Author

Karen Ooms is responsible for overseeing the strategic delivery business unit for Quanticate. This includes the supervision of the clinical data management, biostatistics, programming, medical writing, and pharmacovigilance departments. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a senior statistician at Unilever.
Print this page
Send to a friend
Privacy statement
News and Press Releases

CPhI post-pandemic executive pharma survey: COVID-19 driving manufacturing and CDMOs driving growth

Amsterdam, 22nd April 2021: Ahead of CPhI Discover (17th-28th May, 2021) – global pharma’s largest ever virtual gathering – the CPhI executive post-pandemic pharma survey predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next five years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.
More info >>

White Papers

Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test

Wickham Laboratories Limited

Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement