It’s safe to say that the world has never been more aware of clinical trials than it has been in the past year. And one of the most important, foundational components of a clinical trial is the Independent Review Charter, or simply the Charter.
At BioTel Research, we put high value on the Charter provides because it clearly and concisely defines what we will do at each stage of a clinical trial, including site qualification, image or cardiac analysis, and data delivery. In short, the Charter is the clinical trial roadmap that allows us to conduct our efforts in a consistent and reproduceable manner.
But you need not take our word for how valuable the Charter is; the FDA also believes Charters are a critical component of the clinical trial process—so important that they in fact developed a guidance document that fully outlines what should go into a Charter. And although the Charter is relatively standardized, every Charter still is customized to mirror with the corresponding clinical trial protocol.
Clinical experiments have not always been as controlled as they are today. Did you know that one of the first reported clinical experiments in the history of medicine included a group of people receiving sulfuric acid? As crazy as that sounds, it’s true. By today’s standards, that first experiment was the medical equivalent to throwing spaghetti on the wall to see what sticks.
James Lind, a Scottish doctor in the British Royal Navy, conducted a clinical experiment in 1747 on sailors to determine if adding citrus fruit (vitamin C) to their diet would help cure them of scurvy. After two months at sea, and with many of the sailors afflicted with scurvy, Dr. Lind took 12 sailors and divided them into six groups of two. All sailors received the same diet, which was rich in hardtack, a simple type of biscuit that provided sustenance in the absence of perishable foods. Additionally, the control groups were given unique daily doses:
- One quart of cider
- Twenty-five drops of elixir (sulfuric acid)
- Six spoonfuls of vinegar
- Half a pint of seawater
- Two oranges and one lemon
- Spicy paste plus a drink of barley water
Despite running out of fruit within six days, the results were already noticeable. One sailor from group five (those who were given citrus fruit) was fit to resume duty while the other sailor had almost fully recovered. Apart from that, the sailors who were given cider (group one) were the only sailors who showed any positive effects of their treatment. Lastly, it’s safe to assume how the two sailors taking sulfuric acid faired.
Dr. Lind’s clinical experiment shows how we have progressed from what was once blind experimentation to now developing and running clearly defined, highly controlled clinical trials. At BioTel Research, we recognize the value and role that the Charter plays in this process. If you would like to discuss Charters and our cardiac safety and imaging core lab capabilities in more detail, please contact us at BTRInfo@gobio.com.