Why Pharmaceutical Grade Cannabinoids Are Needed for Clinical Trials

Recently, Tilray made big news announcing that they would be importing Canadian cannabis into the USA for clinical trials. This ruffled some feathers in the US cannabis industry, who operate under state legal programs while the US Federal law insists that cannabis is a highly dangerous and addictive drug with no medical use.

Why can’t Tilray use American grow cannabis for their clinical trials?

Why use Pharmaceutical Grade Imported Cannabis?

There are many factors, but the primary ones are legality, manufacturing quality and consistency.

When performing a clinical trial, including the early stage pre-clinical work such as in vitro and animal studies or safety and pharmacokinetic testing, it is essential to use a pharmaceutical grade product.

Pharmaceutical grade substances should be used, when available, for all research work. The use of pharmaceutical grade substances ensures that the substances tested meet established documentable standards of purity,  composition, and consistency.

This is essential both to ensure validity of the experimental results and to ensure the health, welfare and safety of human and animal trial participants.

The United States currently lacks a reliable supply of legal, good quality, pharmaceutical grade CBD or cannabis products that would be adequate for a clinical trial.

Pharmaceutical Grade Product Hierarchy

  • FDA-approved pharmaceutical substances;
  • FDA-approved pharmaceutical substances used to compound a needed dosage form;
  • USP/NF or BP pharmaceutical grade substance used in a needed dosage form (also includes compounded products from any source);
  • Analytical grade bulk chemical used to compound a needed dosage form (requires justification);
  • Other grades and sources of substances (requires justification).
  • Dilutions and mixtures of substances are considered to be equivalent to pharmaceutical grade only when all ingredients within the solution/mixture are pharmaceutical grade.

Using non-Pharmaceutical Grade Substances in Clinical Trials

Although pharmaceutical grade substances must be used whenever possible, trials must sometimes use non-pharmaceutical grade substances (e.g., investigational substances; compounded substances; Schedule I controlled substances) under certain circumstances (e.g., when a pharmaceutical-grade product is not available, to test novel compounds, or the pharmaceutical grade substance is not concentrated enough to meet experimental requirements).

To obtain approval for the use or substitution of non-pharmaceutical grade substances the following criteria must be met:

Criteria for using non-pharmaceutical grade substances

  • A valid scientific justification is required;
  • Cost savings alone is not a valid justification;
  • Alternative acceptable pharmaceutical-grade substances are not available; and
  • Use of the non-pharmaceutical grade substance has been specifically reviewed and approved by study designers and ethics committees.

From this, we can see that while it may seem sensible to use US cannabis for local trials, the locally available product fails on many levels, and the justification for using a US product (largely patriotic) does not qualify as a scientifically valid reason.

Until CBD and cannabis products are rescheduled out of Schedule 1 importing pharmaceutical grade cannabis products remains the sensible approach for US clinical trials.

GMP Good Manufacturing Practice for Clinical Trials

GMP Manufacturing standards are part of the quality management system used to ensure that products are pharmaceutical grade.

GCP – Good Clinical Practice

Related to GMP is a set of standards for designing and running clinical trials and other areas of clinical practice. These should also be followed to ensure both quality of the compounds used in the study but also the way the product is produced, delivered, blinded and the study planned and implemented.