Thursday, 24 September 2020

Spectrum Therapeutics focuses on Real World Evidence research

12 November 2019 | News

For the safety and effectiveness of Spectrum Therapeutics' medical cannabis products

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Spectrum Therapeutics, the medical division of Canopy Growth Corporation (Canopy Growth), is pleased to announce an Australian first for the company. Spectrum has partnered with Emerald Clinics Australia to collect real world data on the safety and effectiveness of Spectrum Therapeutics' medical cannabis products.

Under the terms of the agreement, following ethics approval, Emerald Clinics will collect clinical outcome data for up to 500 patients prescribed Spectrum Therapeutics products in Australia throughout the course of their treatment. The study, which will take place over the next 12 months, will enable Spectrum Therapeutics to better understand the safety and effectiveness of its products when used in a supervised and regulated clinical setting.

"Spectrum Therapeutics is committed to investing in ongoing local research, while making sure that quality and regulated supply of medical cannabis is accessible to patients in Australia, and this project will allow us to do both," says Dr Christina Xinos, Medical Director at Spectrum Therapeutics. "This partnership allows us to work with Emerald Clinic's innovative care model which ensures that patients receive extensive follow up and support throughout their treatment while collecting real world data which will complement the robust clinical trials required to get our products registered with the Therapeutic Goods Administration."

"Australia's regulatory system enables the collection of high quality data due to the stringent product quality controls in place, and along with the requirement for detailed monitoring plans, this allows us to work towards a more evidence based approach to prescribing cannabinoid medicines," says Dr Alistair Vickery, Principal Investigator and Medical Director at Emerald Clinics.

Spectrum Therapeutics' research program is committed to furthering the science of cannabis through clinical trials and real world evidence approaches, with a focus on conditions with high unmet medical needs, particularly around the areas of chronic pain, anxiety disorders and insomnia. Today's announcement is the first in a series of research initiatives that Spectrum Therapeutics is delivering locally, aligned with its commitment to invest in ongoing global research, including:

  • 24 therapeutic trials planned and ongoing;
  • 26 third party preclinical and clinical studies planned and ongoing;
  • 1000+ patients participating in human health clinical trials; and
  • A unique global pharmacovigilance programme

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