Modern medicine is improving at an astounding rate, and as a result UK residents are experiencing an average life expectancy of around 80 years as opposed to just 70 years in the nineteen sixties. This increase in life expectancy is not exclusively caused by medical advancements, and healthier life styles also have their part to play, but medicine is a significant contributing factor.
In the last 50 years we have developed vaccines to treat a range of ailments, from Rubella to Polio, Hepatitis, and Meningitis. In addition to the development of new treatments, countless existing treatments have been redeveloped and improved upon, increasing their effectiveness and the relief they provide to those who are suffering from the condition for which they were intended to treat.
Cimetidine is a treatment that is used to treat Peptic ulcers, before its development the only known treatment for Peptic ulcers was surgery, which obviously caused patients a great deal of discomfort and distress, not to mention the fact that any form of surgery is inherently dangerous to some degree.
The development of new treatments has undoubtedly improved the quality of life experienced by millions of people and alleviated suffering across the globe. But have you ever stopped to ask yourself how new treatments make it from the development stages to the shelves in your local pharmacy?
Each country has its own drug licensing authority, in the UK it’s the MHRA, and in the USA it’s the FDA. These government bodies are responsible for licensing new treatments so that they can be made available via prescriptions.
The licensing bodies rely on data provided through clinical trials to determine whether or not a new treatment is safe and effective. Clinical trials are carried out by independent third parties who conduct detailed studies on the treatment to determine things like potential side effects, safe dosages, and the effectiveness of the treatment at alleviating the ailment it is intended to treat.
It may surprise you to learn that clinical trials are 100% dependant on volunteers, and that without volunteers it would not be possible for a new treatment to be licensed and made available to those who need it. Volunteers are paid for taking part in the trial, and can often receive between £500 and £3000 for their time. Pre-licensing clinical trials are carried out in three phases as outlined below:
Phase one clinical trials are often referred to as FIH trials (First In Human) because they represent the first time a treatment will be administered to a human being. Initial dosage is very small, and the dosage is built up throughout the duration of the trial, in this manner any side effects that manifest themselves are highly controllable. Phase 1 trials look to identify and potential side effects and establish a safe dosage range.
Phase two trials are carried out on a larger group of volunteers, the study is aimed at determining how effective the treatment is at alleviating its intended condition.
Phase three trials involve between a thousand and three thousand volunteers, they compare the new treatment against other existing treatments for the same condition. Side effects are monitored and additional data is collected to facilitate safe administration of the treatment.