BONUS: Understanding Clinical Trials with Dahlia Kamel, M.S.
Surprise! We’re baaaaccckkk! We have two bonus episodes which means y’all get two bonus blogs! Eeeeee… I know, we’re excited too!
We are also super excited to introduce you to our pal Dahlia. Dahlia is a Clinical Trials Manager at the Penn FTD Center, who joined the Center in December 2020. Dahlia holds a B.S. in Biology, a B.S. in Psychology with a minor in Neuroscience, a Graduate Certificate in Biostatistics and SAS Programming, and an M.S. in Health/Medical Psychology with a concentration in Cognitive Neuroscience.
Dahlia joins us on the mic to discuss, define, demystify and differentiate the vast world of clinical trials – and man oh man, it is vast. Dahlia spoke very thoughtfully and with a comprehensive ease that was super easy to follow! She begins by explaining the difference between research and clinical trials while suggesting that research is “altruistic and definitely not a one-time conversation.” She continues with breaking down observational studies (research) vs. clinical trials. Here is an easy chart:
Without research/observational studies, there are no clinical trials that can take place. Essentially, one doesn’t exist without the other. “We don’t get treatment without the research,” states Dahlia. Dahlia digs deeper into the realm of clinical trials explaining that “a drug goes through a long process before coming to market.” The three different phases (including the “overture”) of the FDA controlled markers are as follows:
1. Pre-Clinical Phase: Drug development period; testing in animals begins.
2. Phase One: 1st time drug reaches a human (side effect observed as is tolerability). Safety and satisfactoriness.
3. Phase Two: More people involved and looking more towards efficacy. At this point, the placebo phase is added in (control groups).
4. Phase Three: continuation of Phase two. Continue to collect data and study long term effects. More people included.
5. Post Trial: FDA takes the notes/info documented and reviews it. A facility inspection takes place, and the FDA combines all assessments to determine if the drug can come to market.
Pre-Clinical Trials to Market is an average of 15 years.
To participate in a clinical trial, Dahlia continues, is not “necessarily for you – it’s for every one after you.”
We learned that deciding to participate isn’t just as easy as signing your name on the dotted line. There is a multi-step process with extensive amounts of conversations and disclosures on both sides – again just highlighting how much Penn truly cares about the participants.
Dahlia shifts into participating in research at Penn and really emphasizes that they truly try to make the experience as comfortable and smooth as possible. She continues to illuminate the fact that clinical trials don’t exist without research. And research doesn’t move forward without the advancement of clinical trials. Similar to what Dr. Corey McMillian said – they cannot exist in silos.
With that being said, it’s with some big delight that we share that we are going to be participating in research at Upenn and will be releasing a three part docu-series on our experience!
Eeeeee! Excited? Us too!
There are many different types of research studies. Participation can vary from completing surveys, to undergoing MRI scans, to participating in studies testing experimental medicine.
While each study has specific criteria for who can participate, there are opportunities for everyone.
Observational Studies gather information and compare data over time and are the foundation for clinical trials by collecting and comparing data over time.
The ALLFTD study is an observational study that gathers data to understand the course of FTD over time.
The FTD Disorders Registry offers people with FTD, care partners, and family members the opportunity to contribute to research by sharing their lived experience through surveys and questionnaires.
Clinical trials test an intervention or treatment. There are a growing number of clinical trials in FTD.
The stages of drug development from preclinical to market can take an average of 15 years.
Resources from AFTD
·AFTD offers an overview of ways to participate in FTD research here: https://www.theaftd.org/research-clinical-trials/ways-to-participate/
The FTD Disorders Registry is the best resource to learn more and stay informed about
FTD research opportunities. Persons with FTD, family members, care partners and health professionals can join to advance the science and remain informed of current opportunities.
AFTD’s Senior Director of Scientific Initiatives, Penny Dacks, Phd shares information about on different types of FTD research and how to participate in a past Remember
Me episode. Listen here.
