Real world evidence: An Indian perspective

Dang, Amit; Vallish, B N

doi:10.4103/2229-3485.192030

Cited by 16 publications

(18 citation statements)

References 10 publications

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“…Such trials are designed to show the real-world effectiveness of an intervention in a broad patient group [ 14 ]. They incorporate a prospective, randomized design and collect data on a wide range of health outcomes in a diverse and heterogeneous population (i.e., they are consistent with clinical practice) [ 15 – 17 ]. Pragmatic trials are conducted in routine practice settings [ 1 ], include a population that is relevant for the intervention and a control group treated with an acceptable standard of care (or placebo), and describe outcomes that are meaningful to the population in question [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

et al. 2018

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Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold standard” for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.Funding: Sanofi US, Inc.

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Section: Introductionmentioning

confidence: 99%

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

et al. 2018

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“…The Indian government has issued national EHR standards, but a burgeoning private sector and lack of data sharing in health care and research are further hurdles. Even in rural Indian settings, EHR can be deployed, and the potential of real‐world evidence is increasingly being recognised . Despite the national EHR standards, low EHR adoption across private and public health care providers and low interoperability across technology developers and academics are significant issues.…”

Section: Foundational Elementsmentioning

confidence: 99%

“…Even in rural Indian settings, EHR can be deployed, 20 and the potential of real-world evidence is increasingly being recognised. 21 Despite the national EHR standards, low EHR adoption across private and public health care providers and low interoperability across technology developers and academics are significant issues.…”

Section: Foundational Elementsmentioning

confidence: 99%

India and the United Kingdom—What big data health research can do for a country

Bandopadhyay

Prabhakaran

Taylor

et al. 2018

Learning Health Systems

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Introduction Big data and growth in telecommunications have increased the enormous promise of an informatics approach to health care. India and the United Kingdom are two countries facing these challenges of implementing learning health systems and big data health research. Analysis At present, these opportunities are more likely to be exploited in the private sector or in public‐private partnerships (eg, Public Health Foundation of India [PHFI]) than public sector ventures alone. In both India and the United Kingdom, the importance of health informatics (HIs), a relatively new discipline, is being recognised and there are national initiatives in academic and health sectors to fill gaps in big data health research. The challenges are in many ways greater in India but outweighed by three potential benefits in health‐related scientific research: (a) increased productivity; (b) a learning health system with better use of data and better health outcomes; and (c) to fill workforce gaps in both research and practice. Conclusions Despite several system‐level obstacles, in India, big data research in health care can improve the status quo, whether in terms of patient outcomes or scientific discovery. Collaboration between India and the United Kingdom in HI can result in mutual benefits to academic and health care delivery organisations in both countries and can serve as examples to other countries embracing the promises and the pitfalls of health care research in the digital era.

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“…In Asia, the growing maturity of real world data sources has led to the recent use of RWE in regulatory discussions, for example, in the decision in Japan on the use of raloxifene for the treatment of osteoperosis 2 . Indian regulatory authorities are also looking to embed routinely collected electronic health records into their decision-making process 3 .…”

Section: Introductionmentioning

confidence: 99%

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

et al. 2018

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Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.

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Real world evidence: An Indian perspective

Cited by 16 publications

References 10 publications

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

India and the United Kingdom—What big data health research can do for a country

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

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