Clinical Trials

Clinosol is celebrating International clinical trials day-2020 to pay a tribute to the research contributions for the public health. To know more about the event, exciting participation events like quiz and pledge for free, please visit www.internationalclinicaltrialsday.org or contact us at 9121151622/623/624 or write to us at clinicaltrialsday2020@gmail.com. 

   

CLINICAL TRIALS (BYGONE TIMES)      

As we are a dominant part of clinical trials, we have been imposed with the foremost responsibility of protecting the rights and safety of the subjects which our history has taught. We, the clinosol team has thought to highlight this piece of work in regard to all the major achievements that made clinical trials possible.  

              The obligatory experimentation of the drugs i.e., the clinical trials was all once started with Legumes, Lemons and Streptomycin. 

562 BC  

one of the earliest recorded examples of open controlled experimental study in history, King Nebuchadnezzar ‘the true father of clinical trials,’ ordered the people to eat only meat and drink wine but some people denied it as they were herbivores. So, the king asked them to eat legumes and drink water only for days. Then, the king assessed that the people who were on vegetarian diet were physically sound than the other meat-eating group. At last the king ordered the meat-eating group to get converted into vegetarian diet. –the book of Daniel.              

  

500 BC 

Hippocrates, ‘the father of Western Medicine,’ is believed to have created the pledge that bears his name. Considering it, all the healthcare professionals swear to practice medicine ethically where the protection of human subjects and it got a modern version in the year 1964. – Hippocrates oath. 

                                                                                                                                  

1537 

Ambroise Pare a surgeon conducted a first clinical trial. He was serving the wounded soldiers with the oil which was a conventional treatment option but some other wounded soldiers got treated with a combination of egg yolk, oil of rose and turpentine oil due to the lack of conventional treatment then he determined that the mixture helped them in alleviating pain and reduced the selling of wound. – Accidental trial.   

  

1747 

The first clinical experiment was conducted by a Scottish physician in the British Navy James Lind tested his theory that citric acids could prevent and cure scurvy, a huge problem among sailors at the time. As there is no way to treat scurvy, many sailors died at sea and some other were suffering from poor wound healing, desquamation and bleeding of gums. During Lind’s controlled clinical trial twelve affected soldiers were divided into six groups, with each group receiving a different supplement in addition to their regular diet. Cider, sulfuric acid, vinegar, seawater, oranges & lemons, and a spicy paste with barley water were all tested. The group receiving the citrus fruit saw positive effects and began recovering immediately. In 2003, Royal College of Physicians established The James Lind Library in remembrance of the 250th anniversary of publication of Lind’s contribution ‘Treatise on Scurvy’. The publicity and popularity of the James Lind Library has made 20 May to be designated ‘‘International Clinical Trials Day’’, because Lind began controlled trial on that day in 1747. 

  

             

1800 

The crucial mile stone in the history of clinical trial: the placebo. The word placebo first was defined in Hooper’s medical dictionary in 1811 as ‘an epithet given to any medicine more to please than benefit the patient.’ Austin Flint U.S physician in 1863 planned the first clinical study comparing a placebo to an active treatment. He treated 13 patients suffering from rheumatism with an herbal extract which was advised instead of an established remedy. In 1886, Flint stated the result of the study as ‘This was given regularly, and became well known in my wards as the ‘placebic remedy’ for rheumatism. The favourable progress of the cases was such as to secure for the remedy generally the entire confidence of the patients.’ – A Treatise on principles and practice of medicine. 

   

1948 

    

The first widely published successful randomized clinical trial of streptomycin for pulmonary tuberculosis. It was a huge success because of the design of the trial and all the credits are for the British statistician Austin Bradford Hill ‘father of modern clinical research’ It was the beginning of the modern era in terms of trial design. – 1948 Watershed. 

  

Ethical and Regulatory framework: 

Human abuses and so many tragedies after the world war-II were all the reason that lead to the evolution of major milestones for imparting ethical guidelines in conducting clinical trials. 

The pyramid below illustrates the evolution of few notable ethical guidelines: 

1906 

In parallel to the implementation of these guidelines the regulatory body Food and Drug administration (FDA) was formed as a scientific institution and became a law enforcement organization in regard of conducting clinical trials. Progressively the need for testing and marketing of the drugs with the main criteria of ensuring safety and efficacy became a primary concern. 

  

    THIS DAY SERVES AS A REMINDER OF CLINICAL RESEARCH HISTORY. 

  

                                                                                                                                                                                                                                                                                                  -  K. Shravani                                                                                               inavarhs247@gmail.com