Patient’s perspective on Clinical Trials in Indian Population

Ms. Priya Maisheri *¹; Dr. Kaushal Kapadia²

1. Texila American University

2 Clinical Research Professional

*Correspondence to: Ms. Priya Maisheri, Texila American University.

Copyright

© 2025 Ms. Priya Maisheri. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: 05 March 2025

Published: 15 March 2025

DOI: https://doi.org/10.5281/zenodo.15044283

Abstract:

Introduction - For conducting a clinical trial successfully, patients’ perspective towards it plays an important role. The patients should have a clear understanding of the reason of their participation in a clinical trial. However, there have been multiple unfortunate incidences in the past that tarnished the image of the clinical research sector in India. Since the last decade, the scenario has changed drastically with constant regulatory updates and improvements in the assurance of patient rights and safety. Nevertheless, scientific illiteracy among a major fraction of the Indian population can cause less patient recruitment and their dropout from the trial. The study aims to find out the positive or negative changes in the perception of common Indian patient population regarding clinical trials and its safety in the last 10 years considering the major regulatory changes in the Indian clinical research sector and public awareness initiatives.

Background information – India is termed as the global hub for clinical trials. Clearly, the number of participants of trial subjects are a concern when number of trials are always on the upward curve. As part of a 2013 study, Dr. Kapadia evaluated the perception and understanding of 6122 patients on clinical research in India as potential clinical trial participants. In this study, many of the respondents were found out to be unaware of the basic principles behind ethical conduct of clinical trial, role of ethics committees, and measures taken by regulatory authorities that safeguards subject’s rights, safety, and well-being. Clear lack of adequate awareness and understanding was demonstrated as the main cause behind the “guinea pig” syndrome.

Methodology - A survey was conducted using validated questionnaires in chronic (long-term) patients groups, and the data collection was through digital or online mode to avoid manual errors and data entry discrepancy. The data collected was analyzed statistically corresponding to our test hypothesis, largely by univariate and bivariate and if appropriate a Chi-square test for association.  Conclusion - The study helped to understand the difference in the knowledge, awareness and perception of chronic patient population on the matters of clinical research, ethical conduct of research in humans, subject rights and safety assurance, compensation laws, and trustworthiness of other stakeholders in a trial. This will also pave the way to chalk out strategies to build and enhance awareness on clinical research in Indian individuals who can be potential participants in human clinical trials.

Introduction

Research aimed at developing new medications, therapeutic procedures or medical instrumentation for human application has historically involved a path full of complex decision-making. Research in this domain requires in-depth knowledge and experience across a plethora of specialized fields involving human biology, law, economics and other subjects. Thus undertaking and completing trials for pharmaceuticals or medical devices requires a dedicated team of expert research professionals and well-structured protocol for safety.  Efficacy of such clinical trials is closely monitored under the guidance of national or federal regulatory guidelines. The cumulative cost and time involved from pre-clinical phase to the final phase can often be put at risk due to a possible single deviation or failure. Patient recruitment, enrolment and retention of the participating patients in a clinical trial can be major causes of failures in this industry [1]. The formulation of the different steps of clinical trials often initiates in the laboratory. In the preliminary phase, the researchers first test new treatments or procedures on laboratory models like animals. If successful, the trial is then allowed to progress to the most challenging stage, which is the clinical trial. The clinical trial is conducted in different phases and the maximum amount of information including the risks involved, effectiveness of the method/drug in question and safety of its implementation is gained during these phases.

Clinical trials are defined as research investigations aimed at testing medical, surgical and/or behavioral intervention on human subjects. Clinical trials are always conducted in a prospective manner, rather than a retrospective manner. The participants of clinical trials are followed forward in time in order to test the efficacy and nature of the process under investigation. However, it is not necessary that trials are carried out exactly from one calendar date to another predefined date. Such a scenario is extremely rare in the real world setting. Participants however, must be followed from a well-defined point in time, which establishes the time zero or baseline for that person in the study. A clinical trial by definition must employ one or more intervention techniques. These techniques may be a single intervention or combinations of diagnostic, preventive, or therapeutic drugs, biologics, devices, regimens, procedures, or educational approaches. Intervention techniques are applied to participants in a standardized fashion in an effort to observe changes in the result. Clinical trial studies may also be comprised of a follow-up of participants over a period of time without active intervention, in order to measure the natural history of a disease process, but it does not constitute a clinical trial. Without active intervention the study is observational because no experiment is being performed.

In case of clinical trials involving humans, the investigator cannot dictate what an individual should do. There are multiple internationally and nationally recognized clinical research guidelines for the ethical conduct of clinical trials globally. These ethical codes are of utmost importance as they focus on providing acceptable conditions for clinical trial participants. Clinical trials involving humans have always been controversial. The history of clinical trials does not stem from a glorious legacy. Clinical trials on humans still remain synonymous with ‘human experimentation’ in the minds of many and bring back the horrifying memories of experiments conducted on war prisoners during the Second World War. The atrocities committed during that period led to the adoption of first ever guidelines for ethical treatment of trial participants under the Nuremberg Code for clinical trials. This document is a legal and ethical code promulgated by the U.S. judges at the trial of the Nazi doctors at Nuremberg after the Second World War. Widely considered as the most authoritative legal reference on the subject of human experimentation, the code is based on universal principles of natural law and human rights, and it establishes the basic principle that the participation in research requires the free, informed consent of the participating subject [2]. Declaration of Helsinki was another set of ethical principles and is one of the most widely known and influential guideline in medical research worldwide. It is an official policy of the World Medical Association (WMA), which was adopted for the first time in 1964 and has since undergone a number of revisions. The Declaration can be viewed as an expression of the WMA’s determination in harmonizing the need to generate sound medical knowledge along with the need to protect the health and interests of research participants [3]. 

Methodology

The study aimed to collect information on the factors that influence recruitment in clinical trials in India. This was accomplished by having the general population complete questionnaires outlining their viewpoints. The questionnaire asked them general questions about clinical trials and the ease of participating in them. The target population for this investigation was selected from various regions of India in order to gather a wealth of data that might be used to improve clinical trial enrolment rates. The responses recorded were analysed to understand the attitude of population in India towards clinical trials. The work presented here is an observational study focused on the primary evaluation of awareness, knowledge and perception of clinical research in India, in a conveniently sampled population of patients suffering from one or more chronic illnesses.

Results

A total of 519 participants took part in this survey. The average age of the participants was 53, with the oldest participant being 88 and the youngest being 33. Among them 317 (61%) were male and 202 (39%) were female (Fig. 2).  A large portion of participants (198 of 519) were not formally educated. 101 were undergraduates while 202 were graduate. Only 12 stated that they had received postgraduate level of education and only 6 had education of more than postgraduate

The question of the survey was ‘Have you heard about Clinical Research?’, which was included in the survey with the aim to get an understanding of how aware the participants were of clinical trials. In response, 77% of the participants stated that they had heard of clinical trials.

Fig 1

When the participants were asked, if they would like to participate in clinical trials, majority (59%) responded negatively.

Fig 2

Next, the participants were asked if clinical research benefitted the society according to them. In response 57% of the participants found it to be true, while only 17% believed this to be a false notion. 26% participants stated that they were not aware on the matter

Next, whether the participants believed that ‘The most important reason for developing new treatments is the advancement of science’. Responding to this, 65% of the participants found the statement to be true, while 30% believed it to be a false notion. 

Fig 3

When the participants were asked if they felt, ‘Clinical research is an essential step in developing new treatments’, 401 of the 519 participants (77%) believed the statement to be true. Only 15% participants did not believe this.

Fig 4

‘If you decide not to participate in research your doctor will not give you good care’. 60% of the participants stated this to be a false concern, while only 35% believed this to be true.

Fig 5

The next question of the survey asked the participants about their idea on ‘doctors force their patients to participate in research’. Majority of the participants (78%) did not believe this to be true, while 7% believed this to be true.

Fig 6

The participants were then asked if they believed ‘Human participants in clinical research are treated like experimental animals (‘human Guinea Pigs’)’. 41% of participants believed this to be true, while 43% believed the notion to be false. The participants were then asked about their opinion on participation in clinical trials being entirely voluntary, to which 76% believed to be true. 21% stated that this notion is false, while 3% stated that they were unaware of the topic.

Fig 7

Fig 8

Next when asked to the participants on their take on the notion, ‘volunteers in clinical research get adequate compensation for their participation’. Only 28% of participants believed this to be true, while 57% believed this to be false.

Fig 9

Please click here to view all figures

Discussions

Clinical trials including people have forever been a questionable point, especially when public insight is involved. The authentic setting of why clinical preliminaries, including people, have been damaged in debates, has been introduced in the proposal's presentation. The intricacies are expanded by many folds when it includes patients. The basic to attempt clinical trials in patients emerges from exceptional advances in the cutting-edge comprehension of essential biomedical sciences. These clinical preliminaries require a matching obligation to translational examination in the event that patient’s wellbeing is to use the increases from these new discoveries. Tragically, many endorsed medicines for youngsters remain yet to be sufficiently tried in subjects. This can sometimes lead to the organization of harmful medications while keeping gainful medicines. Government, industry, subsidizing organizations, and clinicians are answerable for research needs being patient centred because of the expanded weight of diseases in patients, combined with monetary and advertising contemplations. This predisposition has implied that the equivalent freedoms of patients to take part in trials has not always been perceived. The situation has been going through some changes in recent times, nonetheless, as the requirement for clinical trials in patients has been progressively perceived by mainstream researchers and more extensively by the general public, this has prompted new regulation in certain nations making clinical trials obligatory in patients as well as normal people before drug endorsement is given. Clinical trials in patients are more difficult than those in normal people. The pool of qualified patients participating in trials in most of the time is very limited. The current thesis thus investigates which factors are involved in shaping the outlook of the patient population towards clinical research.

People do consent to participate in clinical trials, but because of the social stigma associated with many things in India and the fact that many people in the society do not understand the importance of these things, it is crucial to know how many participants (if any) would feel comfortable disclosing their participation to the general public. In the present investigation, despite having 77% of the participants knowing about clinical trials, lesser number were interested in participating in them. In a similar survey conducted by Kapadia and Parmar, the rate of awareness was found to be lower at 57.63% [9]. These increase might be attributed to greater access to internet and social media achieved during the last few years in India.  Several factors may underlie such negative emotion towards participation in clinical trials. One primary factor behind such negative emotion is in comparison to other options, patients may overestimate the risk and/or severity of the negative effects of clinical trial participation. Patients might be concerned about the clinical trial research's ethical justifications. Mutual concerns may be exacerbated by poor communication between clinicians and minority patients [10]. These issues may be overcome by developing novel strategies in order to better manage the uncertainty around clinical trials. Utilizing patient navigation and patient question prompt lists may improve communication between patients and clinicians. The way the risks of choosing to take part in a clinical trial are presented in comparison to other options may have an impact on patient attitudes toward the risk of doing so.

In the present study 93% were uncomfortable in sharing to the society of their involvement in clinical trials. This was much different than the 2013 observation, where it was recorded that about 72.73% of the population would be fine to share their participation to the society leaving the social stigma aside and it was also understood that the majority of the individuals who were ready to share were from the urban locations, as India being a diverse country, social stigma still continues to be in rural areas.

Conclusion

This study focuses on nearly every general and ethical factor that is connected to participants' perceptions of how clinical trials are conducted in India. Reference has been made to these rules whenever appropriate because clinical trials are possibly the most regulated type of research and are subject to numerous provincial, national, and international regulatory bodies. The ethical standards of good clinical practice and other regulations form the foundation of India's legal framework for regulating clinical trials. It is difficult to guarantee that these principles are upheld in India, but if they are, then people will understand them correctly because they will be the ones being enrolled and may eventually serve as test subjects. This study gives a clear picture of the Indian population's awareness, as well as their knowledge and perceptions of clinical research. Participants' responses inadvertently offer a few recommendations for how we can raise our standards and reduce ethical dilemmas. Almost all general, ethical, and trust-related points and problems in the Indian clinical research environment have been covered in this thesis, along with potential solutions.

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