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Indian healthcare highlights the need for large-scale clinical research and trials or human studies structured in a coordinated and collaborative manner. To bridge the translational gap, extensive research behind understanding the mechanism and assessment of real benefit of drugs requires a new integrated model of clinical research.
According to Dr Upasana Shukla, project manager, Healthminds Consulting, with healthcare costs constantly rising, there is an urgent need to reshape the Indian clinical research and trial landscape. The occurrence of the pandemic has also prominently highlighted the need for both clinical research and trials.
While clinical trial is an experiment to determine whether new drugs or treatments are safe and effective, clinical research is the study of illness in people and a process of learning on how to prevent, diagnose and treat. Both involve human participation that helps in translating basic research into new treatments. “We need to put the two strategies to gather robust and relevant data about the effectiveness of healthcare interventions that can potentially provide optimal patient care within the limits of a healthcare budget,” said Dr. Shukla.
Both clinical research and human studies are vital to enhance health and reduce the burdens of illness. As the former opens new doors to advancing cures for disease and disability, the latter assures the validity of all the research. Both help foster patient-centric studies and increase the diversity of patients that have access to clinical trials. Further, both require shorter turnaround times and be able to deliver enormous benefits, including investigators and patients experience, shorter launch time of new drugs and cost savings of up to 15 to 20 per cent in clinical drug supply, she said.
In addition to pursuing operational excellence, decentralized clinical research and trails are building flexibility for increasingly complex trials, and establishing new capabilities for personalized medicines. After gaining the success curve point, telehealth for trials to improve the patient and investigator experience is also making rounds in the domain. An end-to-end clinical supply chain with advanced data for patient forecasting and interactive response technology (IRT) is driving great flexibility and supports patient forecasting and supply planning. The data is proving to deliver greater flexibility, lower costs, and build a better experience between investigator and patient through improved decision-making and insight generation, said the Healthminds Consulting project manager.
By achieving data flexibility helps to accelerate timelines and conduct more diverse trials which can not only make healthcare accessible to patients but also help pharmaceutical companies to reduce clinical drug supply costs. Individualised treatments can be made with real-world evidence based on interoperable data-trials, incentivising cost reductions through faster in-time communication, collaboration, increased accountability, and reduced errors. This provides first line of consultation that is affordable, qualitative, and fast. We are seeing the clinical trial and development space is changing rapidly. With initiatives like 'Heal by India' and 'Heal in India', the government of India is devising a roadmap for the healthcare ecosystem to open doors for qualified workforce along with promoting affordable and accessible healthcare in India, said Dr Shukla.
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