Non Interventional Studies
Non-interventional studies (NIS) offer the opportunity to collect data on the therapy and its modalities without directly intervening in the treatment itself. They therefore serve to map parameters of clinical practice and gain insights into therapies already used in practice.
| Interventional Studies | Non Interventional Studies | |
|---|---|---|
| Objective | Testing the effect of an intervention (e.g. medication) on a specific target parameter (e.g. effectiveness against pain) | Observation and analysis of the treatment of drugs already used in practice or similar without direct influence by the study to gain knowledge for practice data |
| Control of Variables | Scientists control the conditions in order to gain specific insights into certain variables. | The variables are not manipulated, but observed as they occur naturally. |
| Treatment | Study participants are assigned to a specific treatment strategy in advance, that does not correspond to normal clinical practice. | Drug treatment corresponds to normal clinical practice. clinical practice. |
| Examples | Randomised controlled trials (RCTs), clinical studies | Cohort studies, case-control studies, cross-sectional studies |
Our current Non Interventional Study:
Cannabis extract & Dronabinol compared in practice
Cannaflos is conducting a non-interventional study to gain further insights into the efficacy and safety of a cannabis extract used in practice for pain management. The data from the practical use of this extract will be compared with the data from the practical use of dronabinol to determine whether there are differences in the efficacy and safety of the two drugs.
Background to the question:
Modern treatments for chronic pain combine various therapeutic approaches to achieve a holistic improvement in symptoms. The focus is on the effectiveness and well-being of the patient. Cannabinoids are already used as a second or third choice treatment for some pain syndromes. Studies show that cannabinoids can improve pain relief by 50% or more in a significant number of patients compared to placebos.
Cannabinoid medications fall into two categories: Monosubstances of the main active ingredient, such as dronabinol, and multisubstance phytopharmaceuticals, such as cannabis extracts (NRF 22.7, NRF 22.8, NRF 22.11). Some studies suggest that cannabis extracts are clinically superior to dronabinol.
Possible explanations for this observation are the synergistic effect of cannabinoids and the entourage effect hypothesis, which assumes a pharmacological enhancement of the effect of cannabinoids by inactive terpenes. It is also possible that a combination of these two effects is effective. In addition, the combination of THC with other cannabinoids such as CBD can lead to a reduction in side effects.
Are you interested in participating in the NIS?
We are continuously looking for further physicians willing to participate in our NIS. In case you have interest in participating and contributing to our research, we look forward to hear from you.
You can find more information on the mode of action and safety of our products in the section for physicians.
Recognizing the complexity of the endocannabinoid system and respecting individual differences is crucial in designing clinical trials. This approach holds the key to successful trials, ultimately advancing patient care and outcomes.
Meike Meinzer
Head of Drug Development
Biologist with focus on phytomedicine
Expert on cannabinoids and their therapeutic use
Scientific and clinical conceptualisation
Learn more about our ongoing research projects
A Database of Cannabis Traditional Uses
An in-depth investigation in the traditional uses of the Cannabis plant and the diversity of landrace genetics
Through our research cooperation with IBB and University Valencia, we optimise our genetics to be viroid resistant and genetically stable.
In search of premium quality mother plants, we conduct an ongoing phenohunt program through our network of authorised cultivation partners.
We aim to unlock precision medicine by capturing patient reported outcomes and driving point of care innovation.
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