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As Abraham Lincoln said, “Give me six hours to chop down a tree I will spend the first four sharpening the axe.” Recently, an interested shareholder asked me what Ananda had been doing in preparation for the Randomised Controlled Trials into CIPN and endometriosis.

Often, the lead up to an RCT is longer than the actual dosage period itself. Below, we offer a brief overview of the meticulous planning and execution that our trials require.  We hope this summary provides a clear picture on the work our team has been doing behind the scenes.

The Trial Protocol is a document which details the trial’s objectives, methodologies, dosages, treatment durations, and how outcomes will be measured. It's a crucial phase where scientific precision is combined with research objectives to ensure the study's goals are clear and measurable.  This is key to ensure the measured outcomes will align with the requirements of the regulatory agencies who will ultimately approve a drug for licencing.

Obtaining approval from all regulatory bodies and ethical review boards ensures the trial meets all required standards for safety and ethical conduct.

Writing and updating the Investigator Brochure (IB) is an ongoing task. The IB provides detailed information about the investigational drug’s safety, efficacy, and pharmacological effects and is designed to ensure all trial stakeholders are well-informed about the latest data and developments. The MRX1 IB currently runs to well over 100 pages!

Chemistry, Manufacturing and Controls (CMC)

To ensure consistency and safety is upheld, the investigational medicinal product must be manufactured under strict conditions. This means that the supply chain, from raw ingredient to formulated investigational medicines, is documented in detail and stress tested for robustness. The product is then put on extended stability trials to ensure its formulation is the same over time and in different temperatures.

Training for investigators, site staff, and other trial personnel is undertaken to ensure no errors occur during the trial period. Training covers the trial protocol, data collection methods, and emergency procedures.

Recruitment strategies are developed to ensure the requisite number of participants who meet the study criteria. Materials are developed and outreach programs undertaken to inform potential participants about the trial’s purpose and requirements.

Since announcing the trials, our main focus has been  preparing the investigational product (CMC), drafting the Investigator Brochure (IB)  and providing feedback to Edinburgh on the trial protocols to ensure they meet Ananda’s commercial objectives. We have also been working closely with regulatory consultants on the path to licencing.  Edinburgh University handles recruitment, liaison with internal clinical trials teams to ensure all required sign offs are obtained.