THE LAW AND ETHICS BEHIND CLINICAL TRIALS
Author: Riddhi Kashyap, I year of BBA LLB from Symbiosis Law School, Hyderabad
Clinical trials are the research studies performed by professional experts of medicine and biomedicine on human subjects. The study is entirely based on multiple experiments and observations. These studies are primarily conducted for examining the effectiveness of drugs, supplements, novel vaccines and other medical devices. Over the past few years, the frequency of clinical trials has increased by multiple folds. This is because of the advent of various kinds of drugs and medicines being produced in laboratories of different countries. Not only developed countries but also developing countries have shown improvement in the pharmaceutical sector.
These companies formulate compositions and conduct several trials for confirmation of the same. Generally, a process of five sequential phases is followed:
Phase 0: This is the first phase of any clinical trial which is conducted among 10-15 people. The dose given is very small and only the processing of the drug is observed.
Phase I: This is the second phase where 15-30 humans are used as participants and a suitable dose is administered to them. Participants are tested until they either show the signs of side effects or desired effects. The positive results are only considered to be a signal to proceed further.
Phase II: In this phase, a group of larger people is given certain diseases related drugs. Also, special combinations of medicines are administered. Successful completion of this phase allows the conduction of further phases.
Phase III: A total of more than 100 people are taken into consideration. It is one of the crucial phases of clinical trials as the new drugs are compared to the standard drugs. The participants are divided into two groups. Each group is either given new drugs or standard drugs. The effectiveness is closely watched and approved by experts of the FDA.
Phase IV: The FDA approved drugs are now tested among hundreds and thousands of people. There are not very chances of side effects but experts keep a track of all the people given the drugs.
However, there are specific regulations and guidelines framed for conducting clinical trials in India. The tests must be conducted in compliance with the set rules. All the clinical trials are conducted only if they are by Good clinical practice (GCP) and the Drugs controller general of India (DCGI). Good clinical practice is a designed standard for the entire process of clinical trials. It includes designing, experimenting, observing and analyzing the conducted tests. It provides international code-based laws and is believed to give safe and accurate results. The drugs controller general of India comes under the ministry of health and family welfare. The governmental wing is authorized to approve a license to certain drugs and sera in India. It looks after the whole process starting from manufacturing to distribution. The institutional ethics committee (IEC) is another body registered under the Central drugs standard control organization, Government of India. It aims to work for the interest of human subjects and provide them with ethical standards against all the researches and conducts[i].
Apart from the codes designed for systematic conduct of clinical trials, some basic ethical principles must be kept in mind while commencing clinical trials. There must be respect for the participants, justice to participants, free consent, the providence of compensation, privacy to the name and profile of participants. Humans are used as subjects of an experiment but it must not be forgotten that they are living beings and not mere objects. The experiments must be performed with utmost sincerity and safety. The concept of consent is very crucial and must be dealt with specificity. Sometimes, it might happen that participants consent for the trials but they might not consent for the upcoming risks. The professionals must take it under consideration. The volunteers must be informed about the trial thoroughly along with the desired effects, side effects, and all the other components involved. They must have the right to consent voluntarily and also the option of backing out whenever they want. There must not be any kind of pressure or unfavourable circumstances for the volunteers. Along with this, the participants must be entitled to adequate compensation and medical assistance in times of need. They should be awarded remuneration if they are ill-treated or mishappenings occur. In case of casualties, the family of the volunteer must be reasonably awarded compensation. Also, they must have the freedom to seek legal remedies if they face any misconduct or unjustified treatment[ii].
The conduct of clinical trials is a very ambiguous subject of discussion. The risk involved in it cannot be ignored in any way. Many scholars and academicians have gone through a thorough study of the subject. Many research papers, articles and books have been written by them. There has been both experimental and qualitative nature of research in this area. The laws and regulations related to clinical trials have been projected time and again in almost all kinds of research papers. However, the scope of the ethical aspect has remained untouched to the maximum extent. Very few experts have tried to analyze the matter from an ethical angle. As ethics is the very inherent part of human lives, therefore it cannot be neglected in any way. Therefore, the researcher has tried to approach the matter from an ethical aspect. However, the relevance and importance of laws have also been discussed in this paper. The researcher has tried to examine the validity of clinical trials by looking at it from both the professionals as well as the participant’s point of view. Therefore, the problem identified here is the conflict of interest arising between the volunteer’s safety and the necessity of trials. The matter will be looked upon considering the legal as well as ethical approach.
Clinical trials are conducted to test the effectiveness of novel medicines and drugs before launching them in the market. The intensity of medicines and side effects are all examined during these trials. However, conducting them on human subjects has always been a matter of grave concern. Such tests once experimented on the animals in the lab a long time ago. But those tests proved to be useless and irrelevant. Since the biological functioning of humans and animals are entirely different, therefore it becomes a necessity to experiment with newly formulated drugs on human subjects. The total phases of trials require a long period. It might take 2-3 years for continuous examination and evaluation. All these facts, on the other hand, are threats to human subjects. There is a high possibility of humans getting long term side effects as the result of trials. The risk inherent in the very nature of clinical trials is not hidden[iii]. However there are certain minute details which often get neglected and undisclosed. The conflict of interest arises because human life is more important than examining drugs. But it cannot be ignored that testing medicines are very crucial before administering them to the patients. Both the cases are directly or indirectly related to human lives. The whole situation has been very contradictory and ambiguous for a long time. It has been observed there is no particular solution to this matter.
The conduct of clinical trials also includes an ethical approach along with legal guidelines. As it involves human subjects, therefore the ethical aspect becomes inevitable. Ethical Guidelines of the Indian Council of Medical Research 2006 is one such designed set of rules which talks about the ethical approach of clinical trials. Since human subjects are involved, therefore it is very important to respect them and treat them in the best way possible. The ethical considerations involve informed consent, full knowledge of inherent risk, legal aids available, protecting the confidentiality of patients, and requisite monetary compensation. No volunteer should be denied from backing out of the trial at any point in time[iv]. As it is purely their personal choice, therefore there should not be the influence of anyone or any kind of threat. They should be given all the legal aides in need. Those volunteers should not be exposed to any dangerous nature of drugs or sera. Good Clinical Practices is another set of ethical guidelines which are believed to be practical and has international acceptance. It is a standard set of ethical approaches which is expected to be followed by every public as well as a private organization.
The first laws for clinical trials date back to the era of Britishers in colonized India. Import of illegal medicines and drugs were on the extreme in the time of Britishers. Therefore, to regulate this the Britishers passed The Drug Bill which later modified into the Drugs and Cosmetic Act of 1940. However, due to advancement in biomedicine, this act was further modified into the Drugs and Cosmetics Rule of 1945. This act was the only regulatory act for a longer period. It looked upon the overall process of trials and issued necessary guidelines from time and time. The government, later on, formed the office of Drugs Controller General of India (DGCI) under the wing of the Ministry of Health and Family Welfare. It also structured the Central Drug Standard Control Organization (CDSCO) whose responsibility was to examine all the novel medicine and drugs. It can be observed that there have been tremendous modifications in the law for controlling clinical trials.
After going through various research papers, case laws, journals, articles and books the researcher has come to the point that the matter of clinical trials holds importance in today’s world where innovation and formulation of new drugs and medicines are rapidly increasing. There have been enough designed regulations and ethical guidelines for checking the legal and valid conducts of trials. The entire process has been divided into several phases and each phase is examined with due care. After analyzing the historical background of laws, conflict of interest and ethical approach, the researcher has derived that the conflict arising out of the trials is a serious issue. However, there are no alternatives available to this issue in the current times. The best prevention that can be taken to avoid the threat to human subjects is following the rules and guidelines. There should be complete transparency in the process of trials. Another remarkable point observed by the researcher is that the matter is purely scientific and involves a lot of scrutinies and medical examinations. The organizations or companies entrusted with conducting trials should have a set of professionals and experts. This is again the duty of the government to look after this matter. Only the organizations adhering to the framed norms should be permitted to conduct trials. There should be strict rules and punishments for those who fail to comply with them. The reason behind it is that the process of clinical trials is concerned with human lives and it cannot be compromised in any way. Therefore, the researcher has observed that the conduct of clinical trials requires a lot of scientific advancement to find alternatives for human subjects. The matter has been accurately handled by legislation and courts and therefore only requires close and strict scrutiny.
[i]David Barer, Jose Antonio Sacristan, Ines Galende, Clinical trials, 318, British medical journal (BMJ), 1138, 1138 (1999)
[ii]T. F. Fox, The ethics of clinical trials, 28, Medical-legal journal (med leg j), 132, 134 (1960)
[iii] Kevin Chien-Chang Wu, Precautionary Harm Disclosure in Clinical Trials, 9, American Journal of bioethics (Am j bioethics), 43, 43 (2009)
[iv]Jeremy Sugarman, Ethics in the design and conduct of clinical trials, 24, Epidemiological review (epimedemiol rev), 54, 57 (2002)