Real-World Data – RWD are data relating to patients’ health status and or the delivery of Healthcare routinely collected from a variety of sources. Real-World Evidence – RWE is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of RWD.

RWE studies are valuable across product lifecycle and can provide multiple benefits such as product development, providing evidence to support health outcomes, reduction in resource use, detection of untreated or undiagnosed patients, generating hypotheses for prospective trials, identification of suboptimal dosing, characterizing appropriate treatment subgroups, monitoring safety especially uncommon or rare adverse reactions.

Various sources from which we can collect Real-World Evidence include supplementary information collected during RCTs – Regular Clinical Trials, large pragmatic trials which have a role in evaluating effectiveness of a drug or treatment, administrative data which is collected primarily for reimbursement but contains some clinical opinion and process use with detailed information on charges, electronic health records, and health surveys. For a developing country like India, there are several challenges in the interpretation and inutility of RWE studies. Open, unblinded, and nonrandomized designs used in RWE studies raise questions about their validity.

India is losing out on the tremendous wealth of RWD as it still lags in the number of registries and information stored in them. Healthcare is not financed by the Government given the population size; it sees a slight incentive in assessing Healthcare technologies and building systems to generate relevant data. As a result, registries, databases, medical records, and other sources of RWD have remained underdeveloped in the country.

However, the country has now started taking baby steps towards collecting RWEs. The Indian chapter of the International Society for Pharmacoeconomics and Outcomes – ISPOR has already drafted the proposed PE guidelines for India. PEs analysis helps the decision-makers of a Healthcare system, e.g. clinicians, hospital administrators, health insurance providers, or the Government to optimize the resources in health and provides means for assessing costs and consequences of all available pharma products.

IBM has announced that Manipal Hospitals’ communal and training facilities will implement a cognitive computing platform ‘Watson for Oncology,’ guided by Memorial Sloan-Kettering that analyses data to recognize evidence-based treatment options, helping oncologists to offer cancer patients with personalized Healthcare.

Government of India – GoI has recently launched SEHAT – Social Endeavour for Health and Telemedicine, to empower rural citizens by offering access to information, skills, and other services in different sectors through the intervention of digital technologies, providing diagnostic treatment, free drugs along with insurance cover to treat serious diseases under the National Health Assurance Mission. The Government has also implemented ‘the e-health initiative’, which is a part of the Digital India drive. It aims at offering economical and effective Healthcare services to all citizens. This program can help people maintain health records using eKYC data of Aadhaar numbers.

With a realistic framework for achieving universal healthcare for the masses, India is making positive strides towards the harmonisation of myriad, fragmented health schemes.

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