Demystifying clinical trials: Everything you need to know about process, safety, eligibility

Clinical research in India has evolved significantly in the last two decades. As per a study published in the Lancet journal in late 2020, India has gained more than a decade of life expectancy since 1990 with the development of new drugs. The exponential growth of clinical research, which lies at the core of drug development for innumerable diseases, has played a critical role in achieving this feat. However, with India being home to less than two percent of clinical trials conducted globally, there is indeed a need to do more.

For a country that accounts for 16 percent of the global population and 20 percent of the global disease burden, the volume of clinical trials in India is achingly low. The COVID-19 pandemic has provided the lay public with a general overview of how drugs and vaccines are developed. Clinical trials and how it aids in testing drugs and vaccine has been at the forefront of this conversation since the second half of 2020.

We need greater investment across various parts of the clinical research ecosystem to bring that number up, including public awareness about clinical trials. The lack of awareness about what clinical trials entail has led to patient scepticism about participation in clinical trials.

What are Clinical Trials, and Are They Safe?

Clinical trials are a critical component of the drug discovery and development process. They are carefully monitored research studies to test drugs, devices, or procedures to find out if they are safe and effective before they can be approved for marketing and use for the general public. The investigational product may be new and not tested on human beings before or maybe an existing medicine on the market that is going to be used in a new way.

The conduct of clinical trials in any country, as in India, is guided by local and international guidelines that stipulate the roles and responsibilities of stakeholders and the processes they need to follow. Patient safety and wellbeing are at the core of every clinical trial, and study protocols are designed to ensure that risks to the participants are minimised. These protocols are carefully reviewed by an Institutional Review Board or Ethics Committee and the country's regulatory authority before a clinical trial can start.

Eligibility

The eligibility criteria for each clinical trial varies as per the objectives and requirements of the study. These criteria include specific factors such as age, type of disease, medical history, and current health, among others.

Depending on the study, participants may be patients with a health condition that is not responding to standard medical treatment and wish to access a potentially more effective medicine. Additionally, clinical trials also enrol healthy individuals who may want to volunteer to help advance the understanding of a disease for which there are no effective treatments yet.

Well-defined inclusion and exclusion criteria are put in place for every clinical trial to ensure that only eligible participants are chosen for the study.

Participating in a Clinical Trial

Once a volunteer decides that taking part in a clinical trial could prove beneficial to them, they must go through a detailed assessment to determine if they qualify for the study. If they meets the qualifications and eligibility criteria, the study doctor then takes them through the Informed Consent process.

Informed Consent is a process in which the doctor-in-charge provides the volunteer with information of the treatment, possible outcomes, and benefits of participating in the study. The process is required to be carried out in the language that the participant is most comfortable with.

Participants are presented with the Informed Consent Form, which must be read, understood, and signed by both the participant and the doctor prior to the subject's participation in a study, and a copy of the signed form must be handed to the participant to keep. This document is written at a comprehension level that can be understood by a layperson and is approved by the Institutional (Hospital) Ethics Committee overseeing the study. The Ethics Committee has lay people too who review the consent form to check for accuracy and if the language can be understood by patients. In case the participant is unable to read or write, the study doctor provides all the information verbally in the presence of an impartial witness.

Where a patient is not able to give informed consent (e.g., an unconscious person or a minor), the same may be obtained from a legally acceptable representative. This is a person who is authorized to give consent or intervention in the patient as provided by the law(s) of India. The process is a legal requirement in India and is required to be recorded in an audio-video format.

At any point in time, a participant has the right to refuse to be part of a clinical trial and can withdraw from the study for any reason. By doing so, the participant does not lose their right to receive the current standard of care.

How the Process Works

All clinical studies proceed in phases.

• Phase I trial usually involves a small number of healthy volunteers as participants (except for studies on cancer medicines), intending to check for any potential side effects. Volunteers are generally placed in specially designed, hospital-like clinical units during the course of the study so that doctors and investigators can monitor their health at regular intervals to ensure their safety and well-being.
• Phase II-IV studies involve patients suffering from the existing disease under investigation. Here, the patients are expected to visit the clinical trial site periodically for check-ups and administration of IMPs (Investigational Medicinal Products). The frequency of the visits depends on the drug and disease being studied and the study protocol.

How are Patients' Rights Protected?

The Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare (MoHFW) is the regulatory authority responsible for clinical research oversight, approval, and inspections in India. There are very stringent guidelines set in place for all stakeholders involved, including sponsors, CROs, not-for-profit organisations, and medical institutions that conduct research, to ensure that patients' rights, safety, and wellbeing are always protected. Institute Ethics Committees (IECs) are registered by CDSCO and ensure that institutes that conduct clinical trials hold the highest standards of ethics.

Conclusion

Every drug that we have available in the market today has gone through various stages of testing and the rigour of clinical trials. And it is the participation of volunteers or patients in clinical trials that have led to new discoveries and treatments for unmet medical needs.

Take the current Covid-19 pandemic, for instance. So many people across the world volunteered in clinical trials to help us gain access to working vaccines and treatments for the coronavirus in record time. We must recognise and honour these “Heroes of Medical Research”, for it is because of them that we have access to today’s medicines and new treatments.

Increased public awareness and proactive participation in clinical trials are the keys to developing new treatments for a variety of diseases and meeting the unmet medical needs of patients in India and those around the globe.

The author is the President of the Indian Society for Clinical Research (ISCR)