The Application of ClinTex CTi to accelerate approval of Cannabis Based Medicinal Products

Since 2018, when the UK Home Office announced that cannabis-based medicinal products (CBMPs) were to be moved from Schedule 1 to Schedule 2 status in the misuse of drugs regulations, ClinTex have been closely monitoring associated clinical trials which can help prove that these compounds possess untapped medical utility.

One area where current scientific literature contains ample evidence for the successful application of medicinal cannabis are conditions relating to chronic, non-cancer pain. Chronic non-cancer pain is an oft-cited reason for patients who are already using cannabis for medical purposes. Collecting further data on the effectiveness and tolerability of medical cannabis is key in order to potentially pave the way for it’s approval as an NHS treatment in the future.

The CANPAIN clinical trial being undertaken by LVL Health, will be a non-randomized, non-blinded real-world trial of the safety, tolerability and effectiveness of a CBMP for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management.

The study could run for 3 years but there will be an interim analysis after 12 months with a planned sample size of at least 5000 participants per group, with each patient completing a minimum of 12-months treatment. The CBMP used will be an 8:8 (8% THC, 8% CBD) balanced flower delivered by steam inhalation using a handheld device with flow counting and Bluetooth connectivity.

3 Major Applications of CTi to CBMP clinical trials

Data Quality and Data Completeness:

The CANPAIN study will consist of an initiation visit (or call) to allow screening and baseline data to be collected and then a follow up consultation every three months thereafter, until the end of the trial. CTi can provide valuable oversight to ensure that visit schedules are adhered and to ensure that the right data is collected at the right time. Therefore, regulatory authorities and researchers have confidence that complete and accurate data is being collected to support regulatory approval

In this video you can see an example of where CTi supports Data Quality in a given Clinical Trial

Instream Data Monitoring of Efficacy:

The primary end-point (measure of efficacy) will be the difference in pain intensity scores among patients in the CBMP group compared to matched controls. CTi can help visualize these measures in real time and allow rapid decision making for clinicians to support the success trajectory of the clinical trial objectives

Here you can see an example of how CTi supports Instream Patient Assessment

Safety and Well-Being of Patients:

Secondary end-points will include quality of life, sleep, general well-being, and changes in concomitant medication intake. Safety and tolerability of the treatment regimen will also be monitored. CTi can enable the visualization of all these measures so that any safety signals can be actively monitored to drive instream decision making e.g. dose adjustments, patient withdrawal etc.

This video explains how CTi supports Instream Patient Safety

As clinical trials into CBMPs become a reality, ClinTex will continue to actively engage with the pharmaceutical companies developing these trials. We are confident that this represents a great opportunity for all parties and to showcase the technology behind CTi and bridge the gap between traditional medicine development and blockchain technology and ultimately, to deliver our mission of bringing new medicines to patients — “Faster, Safer, Smarter”

Head on over to our site to check out some further video demos of how CTi can support all aspects of a clinical trial :

https://www.clinicaltrialsintelligence.org/real-world-application-of-cti/

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Clintex CTi

Clinical Trials Intelligence is a data management software solution for the clinical trials industry that leverages distributed ledger technology