What are Clinical Trials?
Clinical Trials – an Overview
Clinical trials are essential stages of research that any potential therapeutic must go through to eventually be certified for use in treatments, no matter how serious the condition. Generally, they are used to assess various different effects and data points within a human population. These are usually predetermined and depend on the study goal. There are 3 stages of clinical trials that a compound must progress through to be considered for approval (phase I, phase II, phase III), however these will be further investigated in a future post.
When it comes to compounds such as psychedelics, early trials are often focused on the safety of the drug and how it metabolized (absorbed) within the human body. This is a vital step to determine whether or not a certain compound will be suitable for future use as a therapeutic tool. After all, you wouldn’t eat a certain food type if you didn’t know that it was safe to consume! Thankfully, these compounds are researched thoroughly to gain an understanding of their safety and tolerability profile before ever being approved for use. This would also be the stage at which optimal dosing is determined, alongside data from pre-clinical trials.
Only after a drug is deemed safe for consumption in a specified dose should clinical comparisons be undertaken. This is what most people tend to think of when posed with the phrase ‘clinical trials’, a new drug under investigation is compared against an existing treatment to measure the respective efficacies. After all, it would be a waste of time and resources researching a drug that had a lesser therapeutic effect. There are exceptions to this case – however this will be covered more within the ‘types of clinical trials’ post.
You may hear about a breakthrough new therapy covered in the news one day, and assume that it will soon be available as a treatment option. Firstly, it is generally considered irresponsible to jump to scientific conclusions – especially when the study size is limited and the drug is in an early stage of the research pipeline. There is always a chance that study errors have occurred, or the efficacy levels are reduced when trials are later undertaken within larger populations. It may be safe to assume that a compound has potential, but blanket statements should be avoided. Because of the highly regulated nature of clinical trials, it may take years for a compound to fully progress through the pipeline.
This post has been intended to provide a simple overview of what clinical trials are and why they are conducted. Further details of the types of clinical trials and study designs will be explored in future posts, so keep checking back to learn more!