Clinical Trials

Clinical trials are used to test new drugs and therapies on human volunteers. Today, these studies were performed using protocols that comply with recognized standards of safety, patient care and data interpretation. However, history shows that patient welfare was not always such a high priority. 

  

Background: Clinical trials: 

  

The earliest recorded clinical trials described in the Old Testament, and describe how Daniel followed a diet of pulses and water instead of meat and wine, recommended by King Nebuchadnezzar II. Daniel remained healthy, while his companions were sick, convincing Nebuchadnezzar to change his mind. 

  

The first clinical trials of a new treatment was conducted without knowledge of Renaissance surgeon Ambroise Pare in 1537. He used a concoction of turpentine, rose oil and yolk to prevent contamination of battlefield wounds, noting that the new treatment was much more efficient that the traditional formula. 

  

Prevention of scurvy:

  

Most people think of James Lind as the father of clinical trials, when he was the first to introduce controls in his experiments. In this way, he proved that citrus fruits in the diet could prevent scurvy. Lind conducted trials while at sea on board the Salisbury in 1747. All scurvy patients received the same general diet but were supplemented with various additional items, including cider, elixir vitriol, vinegar, seawater, and nutmeg (essential), oranges and lemons. In just six days, since the patients, citrus fruits, which were fit for service. 

  

Although the results are clear, Lind was reluctant to recommend use of oranges and lemons, because they were too expensive. It was almost 50 years before the Navy finally made lemon a compulsory part of the seafarer diet, and it was soon replaced by lime juice, because it was cheaper. This is why British sailors, and later the British in general, was called 'limeys' of Americans. 

  

Modern clinical trials: 

  

From 1800 onwards, clinical trials began to proliferate, and more attention was paid to study design. Placebo was first used in 1863, and the idea of randomization was introduced in 1923. 

  

The first trial using proper randomized to treatment and control groups were made in 1948 by the Medical Research Council and involved the use of streptomycin in the treatment of pulmonary tuberculosis. This experiment has also played a blind assessment (where neither the researchers nor the patients knew which treatment group each patient had at the time of the survey), which allows objective analysis of the results. 

  

Since 1945, the ethical aspects of clinical trials has become increasingly important, resulting in a strict regulation of medical experiments on humans. These rules have been enshrined in documents such as the Nuremberg Codex (1947) and the Declaration of Helsinki (1964, amended in 1975, 1983, 1989, 1996, 2000 and 2001). 

  

Clinical trials have become a standard with a focus on patient safety and require informed consent from all participants. There will always be a balance between medical progress and patient safety, and regulation of clinical trials to ensure that this balance is acceptable.