Pharmacoepidemiology for oncology clinical practice: Foundations, state of the art and perspectives

Germay, Sibylle de; Berdaï, Driss; Noïze, Pernelle

doi:10.1016/j.therap.2021.08.001

Cited by 2 publications

(2 citation statements)

References 137 publications

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“…The undeniable benefits of some of these drugs have contributed to an acceleration of premarketing clinical evaluations in the name of rapid access to innovation. Over the last decade, we have witnessed a reduction in the PKI clinical evaluation timeline, justifying the crucial need to complete the data with follow‐up under “real‐life” conditions using pharmacovigilance and pharmacoepidemiology 3–6 . Moreover, these PKIs represent a chemically heterogeneous family with complex affinity profiles 7 .…”

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confidence: 99%

“…Over the last decade, we have witnessed a reduction in the PKI clinical evaluation timeline, justifying the crucial need to complete the data with follow-up under "real-life" conditions using pharmacovigilance and pharmacoepidemiology. [3][4][5][6] Moreover, these PKIs represent a chemically heterogeneous family with complex affinity profiles. 7 In pharmacodynamic terms, this complexity sometimes induces unexpected and serious adverse drug reactions (ADRs) requiring specific management.…”

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confidence: 99%

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Incidence of heart failure following exposure to a protein kinase inhibitor, a French population‐based study

Zelmat

Conte

Noïze

et al. 2022

Brit J Clinical Pharma

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Pharmacovigilance signals of heart failure (HF) following exposure to protein kinase inhibitors (PKIs) have been detected in recent years. Our aim was to identify the PKIs most frequently associated with the development of HF.Methods: Using the French National Healthcare Database, all patients newly exposed to a PKI between January 2011 and June 2014 were followed up for 18 months. Specific hospitalization diagnosis and long-term HF-related disease codes were used to identify HF patients. HF incidence rate ratios (IRRs) were measured and adjusted hazard ratios (aHRs) were estimated using a Cox model. Sensitivity analyses were performed to limit the potential indication and competitive risk bias.Results: Thirteen PKIs were studied. Among the 49 714 new PKI users registered during the study period, the mean IRR of HF was 3.38 per 100 person-years, with a median time to onset of 155 days. We found a significant increase in the incidence of HF for six medicinal products: pazopanib (aHR = 2.42, 95% confidence interval [

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Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

Incidence of heart failure following exposure to a protein kinase inhibitor, a French population‐based study

Zelmat

Conte

Noïze

et al. 2022

Brit J Clinical Pharma

Self Cite

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The possibilities of big data in pharmacoepidemiology, problems of use, legal regulation

Orlova,

Suvorov,

Karseladze

et al. 2024

National Health Care (Russia)

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The growth of digitalization in medicine has significantly expanded the possibilities of using big data in pharmacoepidemiology. The use of big data makes it possible to reduce the cost of clinical research, increase the speed of recruitment and expand the sample, makes it possible to evaluate the effect of drugs in pregnant women and effectiveness in rare diseases. The databases PubMed, Scopus, Web of Science and Google Scholar for 12 years from 2012 to 2023, United Nations documents, World Health Organization, Federal laws of the Russian Federation in the field of artificial intelligence, protection of confidential information, and clinical research were analyzed. The search was carried out by keywords: «big data», «registers», «pharmacoepidemiology», «personal data», «legal regulation», «protection methods». The article provides examples of the use of big data in healthcare, including from 25 to 50 million people. The analysis of the literature data revealed the same type of problems – the lack of uniformity in the introduction of information, incomplete information, limited availability. The review identifies the problems of protecting the confidentiality of information. The mechanisms of information standardization, storage, and data processing are considered. The international and Russian legislative framework regulating the conduct of clinical trials using big data is presented.

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Pharmacoepidemiology for oncology clinical practice: Foundations, state of the art and perspectives

Cited by 2 publications

References 137 publications

Incidence of heart failure following exposure to a protein kinase inhibitor, a French population‐based study

Incidence of heart failure following exposure to a protein kinase inhibitor, a French population‐based study

The possibilities of big data in pharmacoepidemiology, problems of use, legal regulation

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