Ensuring Valid Results: Blinded Trials

Posted on 08/10/22

Blinded clinical trials have become a topic of conversation over the last few years – not just in the pharmaceutical world but in everyday life thanks to COVID-19.  

During the Covid Pandemic, people took it upon themselves to research and understand the way COVID-19 Vaccines came to market and why they were approved quickly. Now it seems that even when I am talking to my neighbors, they understand a little bit more of what Myonex does as a clinical trial supply company and an experienced clinical packager.  

Did you know that the first ever double-blind placebo-controlled trial was conducted in 1943? This trial was created for the treatment of the common cold. The nurse was responsible for assigning the patient to the treatment group and ensuring that the doctor remained blinded. Although this trial did not have favorable outcomes for the treatment of the common cold, this was the start of blinded clinical trials and what is now considered the gold standard for clinical trials.  

Are there different types of blinded trials? YES! There are! The two most used trials are Single and Double-Blind.   

  1. Single-Blind Clinical Trial: A type of clinical trial in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over. 
  1. Double-Blind Clinical Trial: A type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over. This makes results of the study less likely to be biased and are less likely to be affected by factors that are not related to the treatment or intervention being tested. 
In a double-blind trial, neither the patient nor the researcher knows if the medication is a placebo or the investigational drug.

Both types of trials are widely used in clinical protocols, and which one is used for the trial is determined by the sponsor company. A lot of times a single-blind study will be used when there is a noticeable difference between the active and the placebo. This could mean the color could be different or they could not be compounded in the same manner. Whatever the reason may be between the active and placebo this means that the administering doctor can no longer be considered unbiased in the clinical trial.  

So, why explain things that you probably already know? Well, our team at Myonex has been working all summer to expand our services into single- and double-blind packaging. In September 2022, we will “go live” with this new service line to be able to accommodate all phases of a clinical trial. Our team of experienced project managers come with a variety of backgrounds and like to use the phrase “I have seen a packaging operation like that before. We’ve got this!”  

 

What does this mean to our clients? 

  • We can support clinical trials from phase I to phase IV.  
  • Consistent packaging throughout your clinical trial. 
  • Experienced Project Manager on packaging and labeling. 

What kind of facilities do we have to support all this clinical packaging?  

  • 4 GMP packaging rooms at our Headquarters in Horsham, PA. 
  • Capability to expand into 2 large rooms to accommodate the larger batch sizes for phase III and IV trials.  
  • Packaging blinded trials at all storage conditions from:  
  • -80℃ (packaging over dry ice) 
  • -20℃ packaging  
  • 2℃-8℃ packaging  
  • Controlled Room Temperature  

 

We are happy to discuss your needs and how we can support your blinded trial!  

 

 

 

Lauren Roberts

Associate Director, Clinical Trial Packaging and Distribution