Director Customer Relations Medical
There are people who have too many and want to get rid of them, and others who want a lot more, especially on their heads. Guess which group I belong to? (Hint: see photo*).
At proderm, we deal with the needs of people, among other things, and with a lot of experience when it comes to hair, but today we will not talk about permanent hair removal, like for instance with an Intense Pulsed Light (IPL) device. We will leave this topic for a later proderm story.
The project presented in the case study below is a clinical trial where a drug for the treatment of androgenetic alopecia** was tested for safety and efficacy.
As we all know, one of the characteristics of any project is that you never quite know what's coming. "The American Heritage® Dictionary of the English Language, 5th Edition" defines "project" as, among other things, "An undertaking requiring concerted effort."
The measure of a good team for me is how flexible and focused on the common goal the project is implemented.
So were there any hair raisers in this project and did we get a "all is well that ends well" in the end?
By a hair's breadth– What is so special about this clinical study?
Even with the best planning, it is almost impossible to capture 100% of all risks in the risk management plan at the beginning. The world is far too complex for that. Who would have included a global pandemic as a possible risk in an alopecia study a few years ago?
Much more important for clinical projects is an attentive and pro-active team that recognizes risks and acts responsibly in the interest of patients and stakeholders. So when you read the Case Study, keep in mind that this trial was successfully conducted and recruited during the height of the Covid pandemic. This makes the milestones achieved all the more impressive.
In managing the study, we also benefited from our flexible planning with three very differently positioned trial centers, as they have different strengths and thus complemented each other well. In addition to a university hospital and a key opinion leader in the field of hair health and our own proderm Clinical Research Unit, we were joined by a dermatologist in private practice.
The willingness and commitment of the two external trial centers to help generate even unusual solutions in this extraordinary situation also speaks for a wonderful team spirit. An example of cooperation that shines even brighter in times of increased social distance caused by the pandemic.
Measurability of effects is the goal in clinical research. Collecting reliable data with integrity to assess the safety and efficacy of a test product is essential for the safety of participating patients and the approval of new drugs and medical devices. Digital and standardized photography and analysis can be used to collect such data as well as imaging-based endpoints. The challenge with multiple trial sites and study teams is to establish standardization and uniform image quality.
The case study "Androgenetic alopecia" presents key data of the study, shows how we ensured standardized measurement and evaluation of hair growth data and overcame other challenges.
*Unfortunately, proderm employees are not allowed to participate in our own clinical studies.
** Androgenetic alopecia is a form of hair loss caused by hormonal and genetic factors