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Empowering Patients in Clinical Research: A Narrative Review
Pooja Sharma1, Poonam Bagai2, Ashish Bondia3
1Research, APAR Health, Gurgaon, IND.
None:
This narrative review focuses on the evolving shift toward patient centricity in Indian clinical research, highlighting persistent gaps in structured patient engagement. The review synthesizes existing literature on patient-centered clinical research and contextualizes these principles through two India-based initiatives: Patient Advocates for Clinical Research (PACER) and Patient Recommendations for Ethical Decentralized and Inclusive Clinical Trials (PREDICT). A targeted literature search was conducted across Medline (via PubMed), Google Scholar, and the Cochrane Library to identify published evidence related to patient centricity, patient advocacy, informed consent, and patient-reported outcomes. PACER, a published capacity-building initiative, is discussed as an evidence-based example of structured education for patient advocacy groups. PREDICT, an exploratory multicity stakeholder workshop initiative, is described to illustrate emerging patient perspectives on decentralized and inclusive clinical trial practices, without inference of causal outcomes. Both initiatives seek to address critical gaps in patient inclusion in the Indian clinical research landscape. They empower patients to engage meaningfully in the clinical research process by increasing their understanding of research ethics, informed consent, and the roles of different stakeholders in clinical trial design and conduct. These meetings facilitate patient centricity by identifying adherence barriers, optimizing follow-up processes, and acknowledging patient voices, particularly at trial completion. Rather than evaluating intervention effectiveness, this review integrates published evidence with experiential insights to highlight recurring themes such as patient awareness, communication gaps, consent complexity, and barriers to trial participation. By distinguishing between evidence-supported initiatives and exploratory stakeholder engagement, this work contributes to a clearer conceptual understanding of patient centricity and offers practical considerations to inform future clinical research design and policy discussions in India and beyond.
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