Promise of Real-World Evidence for Patient Centricity in Gulf Cooperation Council Countries: Call to Action

Farghaly, Mohamed; Ghaithi, Ibrahim Sulaiman Mas'oud Al; Mahamid, Wael Abdel Rahman; Adlan, Abdallah; AlGhamdi, Saleh Mohammed; Shammari, Thamir M Al; Alqahtani, Nasser Mohammed; Ghnam, Suliman A Al; Ibrahim, Marie Sleiman Awad; Mudaiheem, H Al; Chouikrat, Mohamed Zahir; Aktham, Yahia; Bagoury, Marwan; Gowda, Arun Jayarame; Moaikel, Khalid Al; Abdallah, Nancy Syed Awad

doi:10.1007/s40801-022-00336-0

Cited by 2 publications

(1 citation statement)

References 35 publications

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“…Currently, Middle East and Gulf countries are falling behind in generating and using RWD/RWE for regulatory purposes, while grappling to transform local healthcare systems. However, a limited number of case studies showcasing the use of RWE is indeed available [67]. To address the challenges hindering effective use of RWE in the region, the Gulf Corporation Council (GCC) came together in December 2020 to identify the inherent regional restrictions and propose actionable solutions.…”

Section: Middle East and Gulf Countiesmentioning

confidence: 99%

Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices

Valla¹,

Tzelepi²,

Charitou³

et al. 2023

International Journal of Digital Health

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The use of real-world evidence (RWE) to support international regulatory decisionmaking is reflected in the growing number of regulatory frameworks and guidelines published by Competent Authorities and international initiatives that accept real-world data (RWD) sources. RWD can be obtained from a range of sources, including electronic health/medical records, pharmacy and insurance claims, patient-reported outcomes, product and disease registries, biobanks, and observational studies. However, the availability of RWD sources depends on the processes/systems implemented by regional healthcare systems, which are limited by the potential of inconsistent data collection, heterogeneity of clinical practices, and an overall lack of standardization. As the analysis of RWD/RWE primarily evaluates association rather than causation, it is still often viewed as a supplement to, rather than a replacement of, data that derives from controlled environments, such as Randomized Controlled Trials (RCT). Despite this, RWE may still be used to support the assessment of safety and effectiveness in regulatory submissions and can facilitate regulatory decisions (including reimbursement) by providing longterm data on safety and performance that could not otherwise be collected during the limited duration of a RCT. However, available RWE frameworks reveal serious challenges to the use of RWE for the support of the assessment of safety and effectiveness, due to biases in data collection, lack of randomization, quality of data collection, and generalizability of results and endpoints. Patient privacy and the need to ensure confidentiality also hinders regulatory stakeholders from establishing and implementing concrete regulations. This is because the collection and management of RWD must be used in accordance with national, and often conflicting, laws on data protection and information governance. This article summarizes all currently available RWE frameworks and discusses potential solutions for future harmonization and cross-stakeholder collaborations. Such harmonization and collaboration will boost the integration of RWE, not only in the post-approval stages of a medicine's lifecycle but also in the development and lifelong post-market surveillance of medical devices (MDs).

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Section: Middle East and Gulf Countiesmentioning

confidence: 99%

Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices

Valla¹,

Tzelepi²,

Charitou³

et al. 2023

International Journal of Digital Health

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Streamlining Operations Insights and Innovations From the Gulf Cooperation Council (GCC)

Tariq

2024

Advances in Human Resources Management and Organizational Development

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The chapter examines the challenges, innovations, and best practices that shape the operational strategies of this thriving economic bloc. It combines theoretical concepts with real-world case studies to provide valuable insights to educators and learners into the complexities of operational management in the GCC. The carefully curated case studies offer an in-depth understanding of the operational hurdles faced by GCC organizations and the innovative solutions implemented to overcome them. The chapter also highlights significant trends, future opportunities, and strategic implications for operations management theory and practice in the GCC context. By focusing on operations management, the chapter aims to bridge theoretical knowledge with practical application, enhancing students' analytical skills and problem-solving capabilities in this essential business domain. Ultimately, this chapter serves as a valuable resource for academic communities, practitioners, and policymakers seeking to navigate and optimize their operations in the ever-evolving GCC market.

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Promise of Real-World Evidence for Patient Centricity in Gulf Cooperation Council Countries: Call to Action

Cited by 2 publications

References 35 publications

Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices

Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices

Streamlining Operations Insights and Innovations From the Gulf Cooperation Council (GCC)

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