Sanish DavisAugust 17, 2021 15:02:43 IST
Clinical research in India has developed significantly over the last two decades. According to a study published in the Lancet at the end of 2020, India has extended life expectancy for more than a decade since 1990 with the development of new drugs. The exponential growth in clinical researchh, which is at the heart of drug development for countless diseases, has played a critical role in achieving this achievement. However, India is home less than two percent of clinical trials globally, more needs to be done indeed.
In a country that accounts for 16 percent of the world’s population and 20 percent of the global disease burden, the number of clinical trials in India is painfully low. The COVID-19 pandemic has provided the public with an overview of drug and vaccine development. Clinical trials and their assistance in testing drugs and vaccines have been at the forefront of this debate since the second half of 2020.
We need more investment in different parts of the clinical research ecosystem to get this figure, including public awareness of clinical trials. Lack of awareness of the content of clinical trials has led to patients suspecting participation in clinical trials.
What are clinical trials and are they safe?
Clinical trials are a critical part of the drug discovery and development process. They are closely monitored in studies that test medicines, devices or procedures to see if they are safe and effective before they can be approved for placing on the market and use by the general public. The product under study may be new and has not been tested in humans before or perhaps an existing drug on the market that is to be used in a new way.
The conduct of clinical trials in any country, such as India, is guided by local and international guidelines that define the roles and responsibilities of stakeholders and the processes they must follow. Patient safety and well-being are at the heart of every clinical study, and study protocols are designed to ensure that risks to participants are minimized. These protocols are carefully reviewed by the Institutional Review Board or Ethics Committee and the national regulatory authority prior to the commencement of the clinical trial.
Eligibility criteria for each clinical trial will vary according to the objectives and requirements of the trial. These criteria include specific factors such as age, type of illness, medical history, and current health.
Depending on the study, participants may be patients whose health does not respond to standard medical treatment and who want to receive a potentially more effective drug. In addition, clinical trials also involve healthy individuals who may want to volunteer to help understand a disease for which effective treatments do not yet exist.
Each clinical trial has clearly defined inclusion and exclusion criteria to ensure that only eligible participants are selected for the trial.
Participation in a clinical trial
When a volunteer decides that participation in a clinical trial may prove beneficial to them, he or she must conduct a detailed assessment to determine if they are eligible for the trial. If they meet the qualification and eligibility criteria, the nurse will then take them through an informed consent process.
Informed consent is the process by which the responsible physician provides the volunteer with information about treatment, possible outcomes, and the benefits of participating in the study. The process must be conducted in the language that the participant knows best.
Participants will be provided with an informed consent form, which must be read, understood and signed by both the participant and the physician prior to the subject’s participation in the study, and a copy of the signed form must be provided to the participant for safekeeping. This document is written at a comprehensible level that is comprehensible to the layman and approved by the institutional (hospital) ethics committee that oversees the research. There are also lay people on the ethics committee who review the consent form to check accuracy and whether patients understand the language. If a participant is unable to read or write, the examining physician will provide all information orally in the presence of an impartial witness.
If the patient is unable to give informed consent (e.g., an unconscious person or a minor), it can be obtained from a legally acceptable representative. This is a person who is authorized under Indian law (the Act) to give consent or intervene in a patient. The process is a legal requirement in India and must be recorded in audio-video format.
The participant has the right to refuse to participate in the clinical trial at any time and may withdraw from the trial for any reason. The participant does not lose their right to the current level of care.
How the process works
All clinical trials proceed in stages.
- The Phase I study usually involves a small number of healthy volunteers (excluding studies on anticancer drugs) who intend to review for possible side effects. Volunteers are usually placed during the study in specially designed, hospital-like clinical units so that physicians and researchers can monitor their health at regular intervals to ensure safety and well-being.
- Phase II-IV studies involve patients with the current disease being studied. Here, patients are expected to visit clinical trials regularly for screenings and administration of IMPs (investigational drugs). The frequency of visits depends on the drug and disease being studied and the research practice.
How are patients’ rights protected?
The CDSCO (Central Drugs Standard Control Organization, CDSCO), Ministry of Health and Family (MoHFW) is the regulatory authority responsible for the supervision, approval and inspection of clinical trials in India. Very strict guidelines have been set for all relevant stakeholders, including sponsors, CROs, non-profit organizations and research institutes, to ensure that patients’ rights, safety and well-being are always safe. The Institute’s Ethics Committees (IEC) are registered by the CDSCO and ensure that institutions conducting clinical trials adhere to the highest ethical standards.
Every drug on the market today has gone through different stages of testing and the rigor of clinical trials. The participation of volunteers or patients in clinical trials has led to new discoveries and treatments for unmet medical needs.
Take, for example, the current Covid-19 pandemic. So many people around the world have volunteered for clinical trials to help us get vaccines and treatments for the coronavirus in record time. We need to recognize and respect these “heroes of medical research” because they give us access to today’s medicines and new treatments.
Raising public awareness and proactive participation in clinical trials is key to developing new treatments for a variety of diseases and to meet the unmet medical needs of patients in India and around the world.
The author is the president of the Indian Society for Clinical Research (ISCR)