Safety Outcomes Clinical Significance Vital Signs & Close Monitoring
For this discussion, please navigate to this link: https://clinicaltrials.gov/ct2/show/NCT04042402?term=dcr-phxc&draw=2&rank=3. (Links to an external site.)
This link is a clinical trial poting on clinicaltrials.gov (see here for more info if you are unfamilair: https://en.wikipedia.org/wiki/ClinicalTrials.gov (Links to an external site.)), a publicly avaiable database of clinical trials being run at a minimum in the United States. This particular trial is called “An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria.” Primary Hyperoxaluria is a very rare kidney condition. Long-term safety studies like this one are a common way that clinical researchers gather data about a new drug/biologic/medical device’s safety over longer periods of time (usually 1 – 3 years or even more).
Take some time to read through this post, which is intended to provide patients with important key information about the trial. In your review of the post, please write 2-3 short paragraphs describing:
1. What are some of the different safety outcomes that this trial plans to measure? What do these safety outcomes tell you about the drug? You can find many of these listed in the “Outcome Measure” section of the post.
2. How would you feel about entering into this kind of study if you were a patient with Primary Hyperoxaluria, based on the different safety measures that have been included in the study? Are the measures described clearly enough in the posting or does it seem like it might be confusing for patients?
Please be sure to use proper citations in your post.