The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data

The upcoming January/February issue of Pharmaceutical Engineering will include a contributing article from the Investigational Products COP, “The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data.” The concept of blinding is foundational to the construct and execution of clinical trials associated with the drug development process. In its most simple form, blinding ensures that bias is not introduced into the clinical study by concealing the treatment to which a participant in the trial is assigned. Blinding introduces into the pharmaceutical clinical supply chain additional complexities, considerations, and controls that are not required in a commercial supply chain. In cases where the blind is broken unintentionally and in an uncontrolled way, the costs can be quite high. This is an important topic for clinical supply professionals and those who operate in key functional adjacencies. There is little training and literature available on this topic and as such the upcoming article should be of significant value not only to the investigational products area, but the wider pharmaceutical engineering community, as well. This presentation will provide an update on the progress of the publication, the process of its preparation and key concepts that will be covered in the article.