Back in 2019, if you had asked someone what a clinical trial is, they would probably have looked at you as if you were speaking in a foreign language. Fast forward to the post-Covid-19 era and most people not only know what a clinical trial is, but they can also likely tell you how it works: individuals, whether healthy or sick, volunteer to test a new drug in a controlled environment for a certain period of time.
Before Covid, most clinical trials were conducted in hospitals, with strictly planned follow-up visits over a period of time that could stretch to several years. However, with Covid, came the need for speed and this entire model had to be rethought. This was a big headache for all those involved.
We will take a look at an example of a tech-based solution that is changing the way clinical trials are performed: Cellbox. You will listen to Kathrin Adlkofer, the founder of the company, as she gives us a quick explanation of her innovation.
Clinical trial definition
A clinical trial, or clinical study, or therapeutic trial, is a scientific study conducted on human subjects with the goal of assessing the efficacy and tolerance of a treatment.
Clinical trial phases
There are 3 main phases of clinical trials.
Identifying treatment toxicity
At this stage, the trials are mainly conducted on a limited number of healthy subjects under strict medical supervision. The molecule is tested over a short period. The objective is:
- to evaluate the safety of the product, its fate in the body, its tolerance threshold;
- to define the dose and frequency of administration that will be recommended for the subsequent studies.
To demonstrate the efficacy of the treatment and define the optimal dose
Trials are performed on 40 to 80 patients. The objective is to confirm the preliminary clinical and/or pharmacological activity of the drug at the dose recommended in Phase I.
Compare the efficacy of the new drug to placebo or a reference drug if available reference drug if available
Conducted on large patient populations (several hundred or thousands). These trials are very often multicentric (conducted in many study centers, hospitals). study centers, hospitals). The trials compare the therapeutic efficacy of the molecule with the reference treatment (when it exists) or to a placebo (when no therapy exists).
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