Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation

Breckenridge, Alasdair; Breckenridge, Ross A.; Peck, Carl C.

doi:10.1111/bcp.14026

Cited by 25 publications

(17 citation statements)

References 11 publications

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“…The three institutions are at different stages of RWE development. In US and EU, the development of RWE has entered a relatively mature stage, relevant regulations and pilot projects have achieved direct outputs and promote the practical applications of RWE in the fields of drugs, medical devices and treatment methods (32,56). While RWE is in a rapid development stage in China, some relevant regulations have been issued.…”

Section: Discussionmentioning

confidence: 99%

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Chen

Lai

et al. 2021

Front. Med.

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Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little systematic documentary analysis about how RWE was integrated for the use by the DRAs in evaluating new treatment approaches and monitoring post-market safety. This study aimed to analyze and discuss the integration of RWE into regulatory decision-making process from the perspective of DRAs. Different development strategies to develop and adopt RWE by the DRAs in the US, Europe, and China were reviewed and compared, and the challenges encountered were discussed. It was found that different strategies on development of RWE were applied by FDA, EMA, and NMPA. The extent to which RWE was adopted in China was relatively limited compared to that in the US and EU, which was highly related to the national pharmaceutical environment and development stages. A better understanding of the overall goals, inputs, activities, outputs, and outcomes in developing RWE will help inform actions to harness RWD and leverage RWE for better health care decisions.

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Section: Discussionmentioning

confidence: 99%

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Chen

Lai

et al. 2021

Front. Med.

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“…In recent years, electronic surveys have been employed with limited scope and reach. Digital health methods can be used to measure variability in sleep and subsequent effects on daytime functioning over prolonged periods of time 12 . They also allow researchers to reach and enroll significantly larger study cohorts at a lower cost than traditional research methods 13 , 14 .…”

Section: Background and Summarymentioning

confidence: 99%

Real-world longitudinal data collected from the SleepHealth mobile app study

et al. 2020

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Conducting biomedical research using smartphones is a novel approach to studying health and disease that is only beginning to be meaningfully explored. Gathering large-scale, real-world data to track disease manifestation and long-term trajectory in this manner is quite practical and largely untapped. Researchers can assess large study cohorts using surveys and sensor-based activities that can be interspersed with participants’ daily routines. In addition, this approach offers a medium for researchers to collect contextual and environmental data via device-based sensors, data aggregator frameworks, and connected wearable devices. The main aim of the SleepHealth Mobile App Study (SHMAS) was to gain a better understanding of the relationship between sleep habits and daytime functioning utilizing a novel digital health approach. Secondary goals included assessing the feasibility of a fully-remote approach to obtaining clinical characteristics of participants, evaluating data validity, and examining user retention patterns and data-sharing preferences. Here, we provide a description of data collected from 7,250 participants living in the United States who chose to share their data broadly with the study team and qualified researchers worldwide.

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“…Over 50 years, Sir Alasdair’s research contributions were extensive, spanning basic biology to clinical practice and healthcare delivery, 4 and the use of new techniques to advance regulatory science 5‐8 . His work on hypertension highlighted, for the first time, the role of insulin resistance, another seminal contribution 9 .…”

Section: Contributions To Clinical Pharmacologymentioning

confidence: 99%

“…He contributed enthusiastically to the Pistoia Alliance and several other bodies at the cutting edge of translational medicine. He published his final paper on real‐world evidence regulatory science in the year of his death, 2019 8 …”

Section: Contributions To the United Kingdom And European Communitymentioning

confidence: 99%

Sir Alasdair Breckenridge 1937–2019. A Celebratory Tribute

Peck

Breckenridge²

2020

Clin Pharma and Therapeutics

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Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation

Cited by 25 publications

References 11 publications

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Real-world longitudinal data collected from the SleepHealth mobile app study

Sir Alasdair Breckenridge 1937–2019. A Celebratory Tribute

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