Real-world
evidence (RWE) is revolutionizing drug safety assessment by drawing insights
from diverse data sources that represent real-world clinical practice,
healthcare systems, and patient experiences. This paradigm shift challenges the
limitations of traditional clinical trials, which occur in controlled
environments and may not capture rare adverse events or real-world
complexities. RWE harnesses extensive data from sources like electronic health
records, claims data, patient registries, social media, and wearable devices,
allowing a more authentic perspective on drug safety. The scale and duration of
data collection in RWE facilitate the detection of rare adverse events and
trends that might be missed in clinical trials. Furthermore, the integration of
RWE into drug safety assessment relies on big data and advanced analytics,
including machine learning and artificial intelligence. These technologies
process vast datasets, identify associations, predict adverse events, and
enable real-time monitoring, enhancing drug safety evaluation. In
pharmacovigilance and post-market surveillance, RWE complements data from
clinical trials, providing comprehensive insights into long-term drug safety
and facilitating more efficient adverse event reporting. In the era of precision
medicine, RWE helps identify subpopulations vulnerable to adverse events or
benefiting more from specific drugs, tailoring treatments to individual
patients. However, the use of RWE raises ethical and regulatory challenges
related to data privacy, consent, data quality, and bias, necessitating a
balance between innovation and patient safety. As RWE continues to expand, it
promises to redefine drug safety assessment, benefiting patients, healthcare
providers, researchers, and the pharmaceutical industry. Harnessing the
potential of RWE is crucial to ensure the development of safe and effective
pharmaceuticals in modern healthcare.
Author(s) Details:
Rajesh Hadia,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be
University), Vadodara-391760, Gujarat, India.
Rahul
Trivedi,
Department
of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760,
Gujarat, India.
Cyril Sajan,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be
University), Vadodara-391760, Gujarat, India.
Varunsingh Saggu,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be
University), Vadodara-391760, Gujarat, India.
Sunil Baile,
Department
of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760,
Gujarat, India.
Sunil
Kardani,
Department
of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760,
Gujarat, India.
Hemraj Singh Rajput,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be
University), Vadodara-391760, Gujarat, India.
Please see the link here: https://stm.bookpi.org/RUDHR-V1/article/view/13209
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