Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis

Emanuel Raschi¹, Francesco Salvo^{2

3}, Andrew Bate^{4

5}, Fabrizio De Ponti⁶, Elisabetta Poluzzi⁶, Marco Tuccori^{7

8}, Eugène van Puijenbroek^{9

10}, Nitin Joshi¹¹, Charles Khouri^{12

13

14

15}

Affiliations

¹ Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy. emanuel.raschi@unibo.it.
² Université Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team, Bordeaux, France.
³ CHU de Bordeaux, Pôle de Santé Publique, Service de Pharmacologie Médicale, Bordeaux, France.
⁴ Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.
⁵ GlaxoSmithKline, Brentford, UK.
⁶ Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
⁷ Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
⁸ Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Pisa, Italy.
⁹ Netherlands Pharmacovigilance Centre Lareb, 5237 MH, 's-Hertogenbosch, The Netherlands.
¹⁰ Groningen Research Institute of Pharmacy, PharmacoTherapy-Epidemiology and Economics, University of Groningen, 9713 AV, Groningen, The Netherlands.
¹¹ Adis Journals, Springer Nature, Auckland, New Zealand.
¹² Pharmacovigilance Department, Grenoble Alpes University Hospital, 38043, Grenoble, France.
¹³ University Grenoble AlpesInserm U1300, HP2, 38000, Grenoble, France.
¹⁴ University Grenoble AlpesInserm CIC1406, Grenoble Alpes University Hospital, 38000, Grenoble, France.
¹⁵ Centre Regional de Pharmacovigilance, CHU Grenoble Alpes, CS 10217, 38043, Grenoble Cedex 9, France.

PMID: 38498258
DOI: 10.1007/s40264-024-01419-3

Editorial

Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis

Emanuel Raschi et al. Drug Saf. 2024 Jul.

. 2024 Jul;47(7):601-605.

doi: 10.1007/s40264-024-01419-3. Epub 2024 Mar 18.

Authors

Affiliations

¹ Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy. emanuel.raschi@unibo.it.
² Université Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team, Bordeaux, France.
³ CHU de Bordeaux, Pôle de Santé Publique, Service de Pharmacologie Médicale, Bordeaux, France.
⁴ Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.
⁵ GlaxoSmithKline, Brentford, UK.
⁶ Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
⁷ Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
⁸ Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Pisa, Italy.
⁹ Netherlands Pharmacovigilance Centre Lareb, 5237 MH, 's-Hertogenbosch, The Netherlands.
¹⁰ Groningen Research Institute of Pharmacy, PharmacoTherapy-Epidemiology and Economics, University of Groningen, 9713 AV, Groningen, The Netherlands.
¹¹ Adis Journals, Springer Nature, Auckland, New Zealand.
¹² Pharmacovigilance Department, Grenoble Alpes University Hospital, 38043, Grenoble, France.
¹³ University Grenoble AlpesInserm U1300, HP2, 38000, Grenoble, France.
¹⁴ University Grenoble AlpesInserm CIC1406, Grenoble Alpes University Hospital, 38000, Grenoble, France.
¹⁵ Centre Regional de Pharmacovigilance, CHU Grenoble Alpes, CS 10217, 38043, Grenoble Cedex 9, France.

PMID: 38498258
DOI: 10.1007/s40264-024-01419-3

No abstract available

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References

1. Kusumoto FM, Bittl JA, Creager MA, Dauerman HL, Lala A, McDermott MM, Turco JV, Taqueti VR, Fuster V, Peer Review Task Force of the Scientific Publications Committee. Challenges and controversies in peer review: JACC review topic of the week. J Am Coll Cardiol. 2023;82(21):2054–62. - DOI - PubMed
1. Cohen A, Pattanaik S, Kumar P, Bies RR, de Boer A, Ferro A, Gilchrist A, Isbister GK, Ross S, Webb AJ. Organised crime against the academic peer review system. Br J Clin Pharmacol. 2016;81(6):1012–7. - DOI - PubMed - PMC
1. Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18(6):427–36. - DOI - PubMed
1. Cutroneo PM, Sartori D, Tuccori M, et al. Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems. Front Drug Saf Regul. 2024. https://doi.org/10.3389/fdsfr.2023.1323057 . - DOI
1. Sartori D, Aronson JK, Norén GN, Onakpoya IJ. Signals of Adverse drug reactions communicated by pharmacovigilance stakeholders: a scoping review of the global literature. Drug Saf. 2023;46(2):109–20. - DOI - PubMed

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Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis

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Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis

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