• Scurvy How It Shaped Clinical Trials Forever

    Phase 1 clinical trial

    Scurvy. It was the bane of 18th century life, often destroying the lives of members aboard ships headed across the Atlantic Ocean. It was a man that was named James Lind who began to change all of that. He was the father of an important mechanism seen in today’s society: the clinical trial.

    A clinical trial is a research project headed by scientists or other researchers to determine the effect of a drug that has medicinal and therapeutic value towards alleviating the symptoms or curing a particular illness.

    While clinical trials today are lengthy–in 1999 they spanned 460 days, while in 2005 they spanned 780 days, the first one took less than a week and was done aboard a ship.

    James Lind was a Scottish physician, who is credited with being a pioneer of naval hygiene in the Royal Navy. During his time, scurvy, a disease caused by Vitamin C deficiency, was destroyed whole fleets that were set to go out to the Americas. Scurvy had particular negative effects on ships heading on long-distance voyages.

    In 1740, a particularly nasty event happened. Admiral George Anson, of the Royal Navy fleet, had set out on a voyage to circumnavigate the world. Unfortunately for him and even more unfortunately for the men serving under him, scurvy attacked. It would end up killing nearly 1400 out of 1900 crew members, leading to James Lind’s first clinical trial.

    It wouldn’t just be the Lind’s first clinical trial; it would be the first clinical trial in history. James Lind was the first clinical trial to have veracity; it had control groups.

    In his first clinical experiment, James Lind joined a fleet sailing out to see. After two months, some of the members had contracted scurvy. He divided 12 sick sailors into six groups of two, then gave each a separate antidote.

    One was given quart of cider daily, another 25 doses of an elixir, another six spoonfuls of vinegar, one half a pint of sea water, another two oranges and one lemon, and the last a spicy paste with barley water.

    Only two groups showed improvement–including the one with the fruit. A breakthrough was close to being reached. This was the first clinical trial ever conducted and it occurred in 1747. It would later spur other clinical trials, the growth of which would lead up to the present day.

    Today, in the United States, companies who are developing drugs to treat any number of illnesses must pass through clinical trials whose rules are set up by the U.S. Food and Drug Administration. There are four separate trials, with a fifth being optional at the very beginning.

    These clinical trials can also be considered medical research studies and are in the vein of clinical drug development. Here are the four trials:

    Phase I

    In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time. The purpose of this clinical trial is to evaluate safety of the drug and any side effects that might occur.

    Phase II

    In Phase II trials, the experimental drug is administered to a larger number of people, between 100 and 300, to determine its effectiveness and to further evaluate its safety.

    Phase III

    In Phase III trials, the experimental drug or treatment is administered to large groups of people (between 1,000 and 3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.

    Phase IV

    In Phase IV trials, post-marketing studies delineate additional information, including the treatment’s risks, benefits, and optimal use. As such, they are ongoing during the drug’s lifetime of active medical use.

    Medical research studies aim to find the best possible drug to decrease the symptoms of an illness, whether that illness is hypertension, bipolar disorder, heart disease, or erectile dysfunction.

    Medical research studies are there to shed light on whether a treatment works, how many side effects it has, what the severity of the side effects are, and more. Medical research studies do that and much more.

    A Phase 1 clinical trial or clinical study is a tool of science to determine best treatment methods.