When the average person considers clinical studies, it’s easy for them to assume that they yield quality data.
However, the truth is that a trial is only as good as its design.
Dr. Leen Kawas, who co-founded M3 Biotechnology (later renamed Athira Pharma), discusses common issues that can compromise the data.
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Patients Are Discounted
There are a few issues when it comes to how patients are treated during trials.
Dr. Kawas noted the following:
- Timing: Patients can often be brought in toward the end of trials, which means that their honest feedback is unlikely to be integrated the way it needs to be.
Direction:
The questions that are asked of patients don’t always get to the heart of their experience.
This can lead to the wrong focus for researchers, which can impact how they interpret the numbers.
Inclusion:
The inclusion criteria ultimately have a lot to do with the viability of the results.
If only young and healthy people are considered, it can skew the findings beyond recognition.
Collaboration Drops Off
Clinical trials are a collaboration between medical and clinical teams.
Dr. Leen Kawas points out that the two groups may seem to be on the same page at the beginning of the project, but that individual agendas or miscommunication between the two groups can easily result in compromised data.
Why It Matters
Dr. Kawas is dedicated to helping people feel better, and this can only be accomplished when she has all the facts in hand.
If a clinical study veers off course in any way, it can severely affect the quality of the products she ultimately wants on shelves.
This kind of wasted effort can be avoided when people reconsider their clinical trials from the very beginning.
Connect to Kawas on Linkedin.com
Learn more about Leen Kawas: https://oregonsciencestartupforum.org/speaker/leen-kawas/