samedan logo
 
 
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 pandemicís effect on ongoing clinical trials may threaten scientific accuracy and regulatory compliance. However, with the correct changes and statistical methodologies in place, a studyís 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 doesnít 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

AntTail introduces temperature-controlled solution for worldwide medicine shipments

AntTail has developed a temperature monitoring solution for worldwide medicine shipments that require a constant temperature. The solution consists of Bluetooth temperature sensors that not only monitor temperature, but also detect if and when thermal boxes are opened and closed. These sensors store temperatures and the open/close events and sync data to the secure AntCloud by an app on smartphones or a dedicated Gateway.
More info >>

White Papers

Role of Comparators in Clinical Trial Supply

Clinical Services International

CSI analyses the role of comparators in different trial designs and offers expert advice on robust methodology for choosing the most appropriate comparators. Case studies provide real insight on how to choose comparators for rare diseases and oncology studies.
More info >>

 
Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement