Clinical research pertains to the philosophy of healthcare and can be best approached as an indelible component for improving quality of life; healthcare being a universal birthright of the masses.
Though there have been significant advances in healthcare in recent decades, many medical conditions are still under-diagnosed or inadequately treated or with no available treatment modalities. Continued innovation is mandatory to address the unmet medical needs to balance economic pressures with the growing demand for robust healthcare infrastructure, driven by longer lives & challenges of increasing population.
Need of the hour is an accountable, constructive, collaborative effort by the pharmaceutical industry, medical fraternity and regulators to position India as a global player in the clinical research field by ensuring quality in every aspect. A near perfect union of science, technology, clinical & cost effectiveness is required for an optimal healthcare environment.
Enormous growth in pharmaceutical industry in India has led to the development of clinical research area, one of the fastest growing emerging biomedical markets. Adding to the scenario are an exponential rise in institutes offering certified education in clinical research, high number of referral hospitals, super specialty centres, spread of instant information and IT culture, trained and a hugely informed medical fraternity. This sea of opportunity needs to tapped and transformed into real time build up of fire-walled databases of electronic health and hospital records with pervasive applications in healthcare.
We in India, clinicians, medical scientists, regulatory and pharmaceutical industry need to change our mindsets to acclimatize to the fast scientific progress. A professional improvisation mode is urgently needed alongside assurance of bioethics and safety of clinical trials in India empowered by exhaustive analyses on India being considered the favoured destination.
The foundations for trials for human capital and services that have been laid in India are strong albeit the confidence of quality data collated within stringent timelines and international regulatory acceptance require fine- tuning. These are sufficient indications to show that clinical trials can be woven into the fabric of Indian public healthcare scenario.
Clinical trials in India provide opportunities to patients and access to investigational treatments much earlier to wider market availability; an opportunity to play an active role in the discovery of medicines, treatments, and prevention of disease conditions and also the satisfaction of helping others by direct contribution to medical research. Also, an access to free medical examinations and high-end diagnostic procedures and therapeutic tests and potential compensation for time and travel related to the trial. High priced treatment modalities are made available to the most needed sections of patient population. Clinical trials satisfy public health need of cost-effective, dedicated, detailed investigative procedures in most geographical sections of India.
Trials involving vaccines and molecules having preventive effects have far-reaching socio-economic implications inclusive of immediate health benefits to the exposed population. Those involving diagnostic evaluations especially in early detection of disease patterns would have a huge beneficial impact on public healthcare, can proportionately lessen the burden on governments when used as mass-scale public health intervention.
High quality trials would benefit Indian healthcare only if conducted with integrity and high ethical standards with adherence to the ICMR and GCP guidelines ensuring respect, protection for the human participant, honesty, trust and acceptance of social diversity. Leaders in this industry are aware of the need to build a positive responsible media, to place great emphasis on the ways in which Schedule Y exceeds the demands of the ICH for illiterate volunteers and ethical compensation. Prompt regulatory enforcement action to be meted out to wrong doers. Corporate responsibility rests in doing the right thing rather than the easy thing.
In reality, despite most sincere efforts of scientists, an ideal medicine does not exist and all medicines have possible side effects that some patients might experience. During the development phase, notwithstanding extensive and rigorous pre-clinical and clinical testing done to establish a potential new medicine’s safety and efficacy, not all negative effects can be identified and sometimes even later, following marketing that a predictable risk versus benefit assessment be made.
Encourage clinical trials’ wherever applicable with cheaper indigenous alternative homoeopathyyy, ayurvedic, siddha and unani treatment modalities and obtain authentic data especially in the arena of public health related diseases and with added benefit of global acceptance.
Information dissemination vital for decision making
Dissemination of information is an important spoke in the wheel of healthcare. Edited, peer reviewed journal articles; reference publications of scientific and medical information are to be simple, truthful so as to enable patients and their physicians to take fully informed healthcare decisions.
In view of public interest, sensitive clinical trials are to be mandatorily registered with the CTRI registry with provision of interim concise summaries as the trial progresses. On conclusion of trial, a nuanced analysis of clinical outcomes, clinical processes and impact on healthcare would be invaluable to the medical fraternity. Defined regulatory surveillance systems need to be initiated to maximize benefits of data.
The spirit of trial ethics goes beyond the much spoken, written and hyped “guinea pig informed consent process and coercion’’.Therapeutic access of drugs to patients, ensuing clinical experimentation in India should become a reality.
As of now, a public health need is imperative for an expanded access programme for end stage or hypersensitivity to class of drugs or alternate line of treatment.
In the framework of healthcare, patients with serious or immediately life-threatening disease or conditions that have no alternate or comparable treatment options should be provided access to the use of investigational drugs outside of a clinical trial, also called compassionate use when risks from the drug are not greater than evaluated risks from the medical condition itself.
Nonetheless, the product manufacturer and the concerned physician would need to make special arrangements to obtain the drug for the patient and conditions in place to reduce exposing patients to avoidable risks. Only a few countries and companies have regulated established expanded access programmes with accelerated marketing approval systems in place.
Sensitive clinical trial designs, unbiased patient selection and safe & effective long- term follow ups are essentials for healthcare beneficence.
An amalgamation of public health ethics, health economics and clinical research information, availability of experimental drugs, regulatory and political initiatives can make a difference to the health and well being of Indian public.
The author is Senior Medical Advisor, Lotus Labs Pvt Ltd