spacer
home > ict > spring 2021 > three challenges in creating plain language summaries of clinical trial results
PUBLICATIONS
International Clinical Trials

Three Challenges in Creating Plain Language Summaries of Clinical Trial Results



For years, the scientific community has prepped and planned for the production of plain language summaries (PLSs) of clinical trial results. As part of EU CTR 536/2014, sponsors must submit PLSs – i.e., documents that an average person without a scientific background could easily understand – of their trial results (1). The impetus behind this regulation has been the largely theoretical push for greater transparency. A 2019 Pharmaceutical Medicine article notes that: “Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies” (2).

Over the past year, the COVID-19 pandemic has underscored the demand for such transparency. This global pandemic has served as a case study in the importance of producing scientific information that the public can readily digest. As the world has collectively waited for COVID-19 vaccines and/or treatments, the results of clinical trials have become more interesting and relevant to non-scientific communities than ever before. As Parexel noted in a recent blog post: “Providing a PLS is even more crucial in this global health crisis, where in excess of 100 clinical research studies are being carried out to find a new drug – either to prevent or treat COVID-19” (3).

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


Wendy Farrell is the Senior Director of Content Development for RWS’s Regulated Industries division. In this role, she leads a team that creates and delivers compelling life science content, including articles, presentations, white papers, research, and thought leadership for professionals in highly regulated industries. With over 15 years spent in the localisation industry, Wendy has collaborated with experts and helped organisations build more meaningful connections with their global audiences, through her background in global marketing, sales, solution development, multimedia, and training.

Print this page
Send to a friend
Privacy statement
News and Press Releases

MyMD Pharmaceuticals Announces Issuance of U.S. Patent for Synthetic Cannabinoid Compounds for Treating Neuroinflammatory and Neurodegenerative Diseases

MyMD Pharmaceuticals Inc., a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,085,047 titled “Synthetic Cannabinoid Compounds for the Treatment of Substance Addiction and Other Disorders.”
More info >>

White Papers

Quality of Steel

Natoli Engineering Company, Inc.

Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel. In the design and manufacture of tablet compression tooling, nothing is more important than the quality of the materials being used. The best manufacturing principals maintaining the tightest tolerances will result in tool failure if the initial material quality is poor. Material quality is the fundamental building block upon which all successive value added steps are laid. The majority of all tablet compression tooling is produced from steel and steel quality is the subject of this article.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement