Augmentation of clinical practices forms the ultimate goal of scientific contribution of clinical research by applying the potential results to influence change in practices and focus on generating new knowledge to improve medical care and patient outcomes. The extended longevity of man over the past century can be substantially attributed to innovations consequential to medical research.
A collection of strategies can be utilized to revitalize and stimulate research in settings of hospitals and clinics. The value of clinical research is enormous as it facilitates the testing of evidence-based systematizations to improve healthcare, by promoting interim evaluations of the execution of best practices in the clinical environment, impacts clinical practice organization, continued growth & development of quality, also critically contributes to the scientific basis of medical care.
The present
The soaring costs involved in drug development have compelled the R&D industry to look for novel, smarter ways of conducting clinical research.
India scores high with a heterogeneous pool of more than one billion population with prevalence rates of exclusive disease profiles that match those predominant to the west therefore appealing to pharma giants. The west is no match to India’s country specific factors in terms of its larger geography, treatment naive patients, large population densities & heterogeneity. Trials conducted in emerging economies like India with treatment naïve patients can theoretically generate more reliable & evaluative pharmacokinetic and pharmacodynamic data, also easily providing large genetically diverse patient pools essential to complete trials.
India is empowered with high patient to doctor ratio, quicker patient accrual rates, with good patient compliance especially significant in the context of increasingly large studies with big sample sizes of target populations partly essential due to scientific and statistical inferences & additionally to pre-empt adverse post marketing safety controversies. India has a growing literacy rate beyond 65 per cent with life expectancy touching 65 years.
For the knowledge - based pharmaceutical Industry where protection of Intellectual Property is critical, India is presently an almost ideal tripartite destination for manufacturing, research & development, an assurance of relatively inexpensive, rapid & dependable data, in addition to being a potential market. India has become TRIPS compliant since January 2005 with formal protection of product patents. Patent protection is now comparable to that in developed nations & broadly encourages R&D. India is ascending the global value chain by supplying bulk APIs & additionally a number of home-grownn NCEs in pertinent therapeutic areas, nonetheless, marketed worldwide by MNCs in the coming years.
In India, 90 per cent and more of clinical experimentation are outsourced by pharmaceutical MNCs mostly in therapeutic domains of infection, oncology, followed by cardiology, psychiatry & the rest distributed across other specialties.
Supportive tertiary infrastructure comparable to global standards:
Accessibility to teaching, referral hospitals and super speciality hospitals, with the world’s largest pool of qualified medical and healthcare professionals for conduct of research backed by superior nursing standards accompanied by safe patient follow up in urban and semi urban areas of India. Numerically, the audited clinical facilities and accredited research laboratories, have galloped in the last decade.
Impartation of medical education in English & increasing adoption of GCP guidelines by healthcare personnel all add to a plethora of trials being transferred here. The burgeoning Indian CRO/SMO industry, perceptive to quality is recognized for its invigorated & stringent management of clinical studies being on par with global standards.
Presently, India presents one of the largest markets in the clinical development outsourcing networks with an inundation of clinical studies from European and North American sponsors. The high end availability of biotechnology, bioinformatics & IT- pharma ventures has contributed to exceedingly accurate, reliable, qualitative exportation of scientific data to disciplined global regulatory structures.
The Indian regulatory landscape has remediated processes & quality standards to meet international criteria by resuscitating clinical research. The Schedule Y of the Drugs and Cosmetics Act has been amended in 2005, the DCGI office has implemented inspection systems to track the progress of drug trials, made GCP compliant protocols mandatory, greater safety by insisting on additional toxicology testing, biotech IMPs undergo scrutiny with central lab evaluation, has evolved into accepting concurrent global trials on Indian soil. Presently deliberating on conduct of first in man trials inclusive of phase 0 micro dosing trials with NCEs developed outside, consideration of mandatory registration and regulation of ethic committees and CROs (more than 200 presently). It has implemented the Clinical Trial Registry India with compliance to full disclosure of the 20-item WHO ICTRP datasets, as well as supplemented with items of the CTRI dataset. The Indian regulatory has collaborated with the US FDA & other international agencies and working towards evolving into a single–window, e-governance drug regulatory system to support efficiency and transparency for all public, pharmaceutical and healthcare stakeholders.
The delays encountered with Indian regulatory approvals are overcome by accelerated patient recruitment & patient compliance practices which are crucial factors impeding clinical development abroad.
As a consequence of steady growth in economy and stable political environment combined with aforementioned advantages, global biopharmaceutical companies have justifiable strategies to relocate substantial number of clinical trials to India.
The future
Good research leads to good health outcomes. Medical care should commensurate with current scientific affirmations thus poorly-informed medical decisions are some of the reasons why health services from time to time fail to reach those most in need. Research helps entrench and actualize mechanisms of translational medicine (bench-to-bedside approach) to communicate knowledge in support of evidence-based health related policies. The government should be urged by regulatory and medical fraternity to allocate funds for research, including support for medical knowledge translation practices. Developing infrastructure for institutionalized clinical research should be prioritized, though not easy, nevertheless represents an important milestone; as an assessment of robustness of research in any country is considered a good indicator of its healthcare. Private industry research sector contributes to around 70 per cent of R& D in India with the rest coming from CSIR, ICMR, few universities & pharmacy colleges. This scenario needs to change.
The demands of everyday patient care takes precedence thus conducting research can prove challenging in a clinical setting. A number of limitations exist in absorbing research in clinical practice: ignorance, negative attitudes, research findings not communicated to bedside clinicians or not reported in terms that can be understood for application into clinical practice, lack of time, and administrative support amongst others.
The Medical Council of India, state medical associations and universities can play dominant roles in propagation and integration of clinical research & methods in medical and post-graduate curriculum with academic restructuring, as the present focus is principally catering to daily clinical practice. They should be encouraged to cultivate dedicated research wings for development of state-wise registries of potential investigators who are GCP trained with knowledge of ethics & regulations, which India sorely lacks. Link all research institutions, form a coalition of public owned & private healthcare units’ further liasoned to regional pharmacovigilance centres. Government agencies should also regulate & monitor all Institutions imparting bioresearch education. Collaborative R&D mandates continuous coordination, supervision, guidance & training.
Hospital-attached medical laboratories should evolve to accredited status and supported to maintain GxP standards of quality assurance & be linked by laboratory information software systems interfaced with comprehensive datasets of hospital information systems essential for global regulatory acceptance of clinical data gleaned from trial based pharmacotherapies.
The government & regulatory should encourage research in neglected diseases of public concern including malaria, HIV and tuberculosis, analogous to the incentivized orphan drug model followed in developed countries; also concurrently ensure economic price control of prioritized treatment modalities.
Discourage research of products not providing major therapeutic benefits over existing products.
Develop industry based push incentives from public subsidies in addition to the much accepted pull incentive of market exclusivity to innovators protected by the patent laws.
Develop and demonstrate domestic skill sets to complete the entire process of drug development from start to finish model of home grown NMEs eventually to be strategically marketed both in domestic and developed markets.
Provision of research status to hospitals that foster innovative interdisciplinary synchronized research with academicians (physicians & surgeons) whilst functioning hand-in-glove with basic research scientists and the R&D industry. The medical research platforms should conform to the clinical research agenda where originations are nurtured & converted to wide-ranging intervention measures of patient care.
On site, grass root hospital based research activities may consist of a wide multidisciplinary array; tissue engineering, gene therapy & vectors in healing of ischemic wounds, stem cell therapies & cell regeneration, bone substitutes, critical care procedural assessments & outcomes, nanobiology, tumour immunomodulation, surgical research practices in parallel with patient care etc.
Maximize applications of research to a large number of patients in hospitals/ clinics with the ensuing need to target high-priority areas of patient care in the particular speciality & also serve to pique the interest of the researcher.
Consistent publishing of peer reviewed articles in reputed journals emphasizing reports of clinical investigations & fundamental research bearing directly on clinical management covering a broad range of interests to promote shared visions of research and academic pursuits through the exchange of ideas between residents, practising physicians, surgeons & academia. The gap between academics and practitioners should diminish. Business ethics should not erode the integrity of academic medicine as corporate priorities could collide with patient safety & ethical concerns.
The future use of telemedicine & telehealth in the provision of specialist clinical services & research by store-and-forward, or remote monitoring or as interactive mediums are attributed to cover the entire spectrum of health care practices.
A forum of clinical trial leaders should aggressively market services, showcase skill sets inclusive of cross functional GxP standards in India to the world, adapt business outsourcing models to suit more complex global regulatory spearheaded by the Government of India.
The influential mass media should responsibly advocate good research and check against deliberate and distorted campaigns.
In the recent years, the maturation of metabolomics technologies dealing with interaction between genetic and epigenetic factors is bound to have a profound effect on pharmaceutical R&D as a part of predictive medicine, which in turn would bestow in great measure to practice personalized & preventive medicine.
Conclusion:
For all partners and stakeholders the need of the hour is an Indian clinical research interchange platform to champion sustained biomedical research and create optimism by adopting innovative approaches to enhance the quality of clinical trials and expunge major blips in the research field.
Biopharmaceutical researchers have an obligation to cohere to best practices irrespective of where their research is located, which remains an ongoing challenge for governments ubiquitously. A voluntary academia & industry-led initiative may be the truly effective way to achieve best practices in clinical trials of course, being supported by infrastructure, documentation, transparency, services and disclosure, appropriately aligned with market incentives assisted by regulators; the potential of research is to be harnessed by drawing on emerging technologies and sciences to address priority health challenges.
It’s rocketing times for clinical research in India with the eventual aim of the country’s potential of becoming a world power in clinical research.
The author is Senior Medical Advisor, Safety and Pharmacovigilance Lotus Labs Pvt Ltd, Bangalore