Use of Real-World Evidence for Oncology Clinical Decision Making in Emerging Economies

Abstract

Real-world evidence (RWE) can provide insights into patient profiles, disease detection, treatment choice, dosing strategies, treatment sequencing, adverse event management and financial toxicity associated with oncology treatment. However, the full potential of RWE is untapped in emerging economies due to structural and behavioral factors. Structural barriers include lack of regulatory engagement, real-world data availability, quality and integrity. Behavioral barriers include entrenched healthcare professional behaviors that impede rapid RWE understanding and adoption. These barriers can be addressed with close collaboration of healthcare stakeholders; of whom, regulators need to be at the forefront given their ability to facilitate use of RWE in healthcare policy and legislation.

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

“…Further research identifies a few key factors that impede the generation and use of RWE within the GCC countries, including: (1) the lack of guidance and frameworks from regulatory agencies; (2) the lack of public confidence and openness in sharing data; (3) the inability to trust RWD and avoidance of stakeholders in using RWE; and (4) the lack of partnerships and collaborations between data sources and the lack of real-time data dissemination [21][22][23].…”

“…The US Food and Drug Administration (FDA) in December 2018 published the "Framework for FDA's RWE Program" to provide guidance for three important areas; (a) assessing the fitness of RWD with respect to reliability, relevance, and data gaps; (b) assessing sufficiency of evidence with innovative study designs and pragmatic trials and external comparators; and (c) assessing regulatory requirements and guidance for electronic data capture [24,25]. Gulf Cooperation Council countries regulatory agencies are recommended to update and provide consistent guidelines on RWD and RWE that can capture reliable and useful RWE for patient treatment, cost coverage, regulatory, and health policy decisions [21,22]. Guidance can be sought from the International Society for Pharmacoeconomics and Outcomes Research Special Task Force on RWE and collaboration with the International Society for Pharmacoepidemiology, and sponsors should ensure that transparency, validity of confounders, measurement lapses, selection bias, and missing data rates are optimized in the studies [26].…”

“…However, the GCC countries have not been able to fully utilize their potential benefits so far. A number of barriers restrict effective RWE efforts in the countries, such as the absence of regulatory guidance and frameworks, perceived fear and mistrust by the public in sharing personal health data, a lack of collaboration and partnership between institutions, variability in data sources, knowledge gaps, and a lack of technological prowess [21][22][23].…”

A review on generation of real-world evidence

“…Patient registries have Countries in the developing world are also beginning to adopt RWE. Though at an incipient stage in emerging economies, use of RWE has gained momentum over the past five years growing at a rate of 11% a year [44]. China has used RWE to develop evidencebased guidelines for percutaneous coronary interventions [45].…”

Análogo de somatostatina no tratamento de tumores neuroendócrinos avançados do trato digestivo - dados do mundo real de um hospital universitário do sistema único de saúde

“…Após a publicação dos estudos PROMID e CLARINET 49,50 , o uso de análogos de somatostatina foi incorporado ao tratamento dos TNE-GEP metastáticos ou irressecáveis 56 . Em ambos os estudos, a amostra ficou restrita a pacientes do continente europeu, sem representação de indivíduos provenientes de países sulamericanos 49,50 .…”