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Clinical Research Coordinators

History

The study of patients with various ailments and diseases and the testing of cures dates back centuries. Avicenna, often called the father of modern medicine, wrote in 1025 A.D. in his Canon of Medicine about following rules for studying disease and testing remedies, including studying two cases at the same time. In 1537, Ambroise Pare, a surgeon, used different treatments on soldiers who'd been wounded during battle to see which would work. The high numbers of wounded soldiers and the lack of supplies forced him to use unconventional treatments. For example, treatment oil was not available, so he substituted egg yolks, rose oil, and turpentine, which worked.

The first controlled clinical trial conducted by a physician occurred in 1747. Dr. James Lind was a physician on a ship when many of the sailors contracted scurvy, and the mortality rate was high. Lind aimed to find a possible cure. He chose 12 patients with similar symptoms and gave small groups of them different treatments to determine which held the most promise for curing scurvy. The results proved that the patients who were given oranges and lemons recovered best and were fit for duty within a week. Oranges and lemons were expensive at the time so Lind withheld recommending this treatment. By the early 1800s, however, the British Navy made lemon juice, and later lime juice, a required part of seafarers' nutrition.

The use of placebo in clinical trials began in 1863. Physician Austin Flint studied a group of patients with rheumatism. Flint treated patients with a dummy remedy as well as with an active treatment; he did this in two separate trials, however, and then compared the results. The Medical Research Council in England conducted a comparative research trial in the 1940s of patients (British office and factory workers) who were experiencing the common cold and the effectiveness of a specific type of Penicillium treatment. This study was unique in that the patients as well as the physicians did not know what the treatment was, for a double-blind controlled trial.

In 1906, the U.S. Congress passed the Food and Drugs Act to regulate the manufacture of food and drugs. The laws are continually reviewed and tightened, and increasingly mandate clinical research trials be conducted before products are released to the public. The Nuremberg Code was established in 1947, providing guidelines for ethics in medical research on subjects. The Helsinki Declaration was introduced in 1964 to protect subjects who consent to medical or scientific research from harm during clinical trials.

Clinical research today continues to focus on understanding human disease and developing ways to prevent, diagnose, and treat disease. New treatments and therapies are tested and the natural history of disease and health progress is researched. According to PhRMA, in 2014, the U.S. pharmaceutical industry employed nearly 854,000 workers and had a $558 billion impact on the U.S. economy.