Introduction
Clinical trials are a systematic study of pharmaceutical products on human subjects which in turn help determine the safety and the efficacy of a particular drug.
History
In 1537, the first clinical trial of a new therapy was conducted by a surgeon named Ambroise Pare. Though it was an accidental revelation, still he managed to save several wounded soldiers on the battlefield. He applied a mixture of the yolk of eggs, oil of roses, and turpentine in place of a medicinal oil that was scarce, on a few soldiers.
In 1747, James Lind, a reputed physician conducted what came to be known as the first controlled clinical trial of the modern era. While he was on the ship, he witnessed a high mortality of scurvy among the sailors. He selected a group of sailors with this condition and who were having a relatively similar meal, day and night. Then he exposed them to different treatment methods and observed which is the most effective dietary substance to cure scurvy sailors.
Indian Scenario
Critics argue that it is a Western concept and was not originated in India. Two of the ancient scriptures, Charaka Samhita and Sushruta Samhita have mentioned medical research. It dates back to 200 B.C. and 200 A.D. respectively. Though, with the coming age of modern technology and scientific techniques, a lot has changed since then. In the 21st century, certain guidelines laid down by the International Conference on Harmonization (ICH) are followed in order to conduct clinical trials. In India, certain laws legalize clinical trials and have laid down detailed procedures. Some of them are a) the Drugs and Cosmetics Act, 1940; b) Guidelines for Exchange of Biological Material, 1997; c) the Right to Information Act, 2005 and d) The Biomedical Research on Human Subjects Bill, 2005.
Relevant Laws
Rule 122DA of the Drugs and Cosmetic Rules, 1945 states that an application has to be filed with the licensing authority to seek permission for clinical trials for a New Drug/Investigational New Drug. There are three subcategories under this rule. Rule 122DA 2(a) elaborates that in order to conduct human clinical trials, form no 44 along with Rs 50,000 have to be submitted to the licensing authority. Alongside this, other necessary information is laid down under schedule Y which has to be furnished. This is categorized as phase 1.
Next is phase 2. Rule 122DA 2(b) states that in order to conduct exploratory clinical trials, data has to be gathered from phase 1 trial, and a sum of Rs. 25,000 is to be submitted, along with this. Finally, phase 3 known as the confirmatory clinical trial gathers data essentially from the phase 2 trial, and wherever necessary, phase 1 trial data is also noted. An amount of Rs 25,000 is to be furnished along with this.
The Objective of different phases
Human pharmacology or phase 1’s objective is to understand the safety bar of a drug and whether it is tolerable to the human subject, upon giving a small dosage. It is generally conducted on healthy volunteers or a specific category of patients. Therapeutic exploratory trials or phase 2 are conducted to understand the effectiveness of a drug for a particular condition, upon a narrow group of patients. This group is homogeneous and has been shortlisted after witnessing a relatively narrow criterion amongst them. Therapeutic confirmatory trials or phase 3 trial is basically conducted to lay out the therapeutic benefit of the new drug. It confirms whether a drug is safe to use or not. It should be able to enunciate how much dose is to be given to a selected group under phase 2 and how much to a wider population. Further, it should be able to inform in case of a particular disease, the amount of the drug taken in combination with some other drug.
Unethical clinical Trial
Many times, drugs are tested upon individuals of a particular country without informing them of the actual mishap that can take place if the trial is not successful. Moreover, at times the consent is not even voluntary. In India and many other developing countries, several such cases of unethical clinical trials have taken place. One such example is that of a trial of Lapatinib – a drug for breast cancer.
The Outcome of the Trial
Since most Indians do not have the means to support themselves to have a good quality life and accessible health care, henceforth many of them accept the opportunity in the hope that it might provide quality life and they may be treated effectively. Vulnerable people become their guinea pigs and also because they are in dire need of the medication, henceforth they are willing to take every risk that comes their way.
Another example of a drug trial that was conducted in India and was regarded to be unethical was the trial of Risperidone by Johnson & Johnson. The trial design that was laid down by US regulatory authorities was deemed to be absolutely unnecessary. Patients who were tested were from both, private and government hospitals. More number of them were from government hospitals who were seriously ill. Due to this, it could have affected their consent. Moreover, they saw this as a way to get free medical care. Those who were a part of this trial had acute psychiatric conditions. Before giving them the actual treatment or the placebo effect, they were removed from every kind of medication, and the ones who were given the placebo effect were certainly deprived of the actual treatment.
Conclusion
Unethical clinical trials should be strictly banned and authorized permission for the clinical trials should also be given after a thorough background check, of the ones conducting it, the place at which clinical trials are to be conducted, and whether the patients are duly informed of the entire process along with the consequences that might take place if the trial goes haywire. After fulfilling the requirements laid down under Schedule Y of the Drugs and Cosmetic Rules and abiding by other such necessary laws, should the trials be conducted? The utmost care of the patients should be taken as they are the ones risking their lives for a greater cause.
Author(s) Name: Mehar Khaneja (Advocate at Punjab and Haryana High Court)
