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6. Real‐World Evidence to Support EU Regulatory Decision Making—Results From a Pilot of Regulatory Use Cases.

Author

Prilla, Stefanie, Groeneveld, Sophie, Pacurariu, Alexandra, Restrepo‐Méndez, María Clara, Verpillat, Patrice, Torre, Carla, Gartner, Christian, Mol, Peter G. M., Naumann‐Winter, Frauke, Breen, Kieran C., Gault, Nathalie, Gross‐Martirosyan, Liana, Benchetrit, Sylvie, Aylward, Brian, Stoyanova‐Beninska, Violeta, O'Donovan, Maura, Straus, Sabine, Kjaer, Jesper, and Arlett, Peter

Subjects
EVIDENCE gaps, ADVERSE health care events, CHILD patients, RESEARCH questions, RARE diseases
Abstract

Studies using real‐world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down‐stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology. A significant number of questions were related to the pediatric population and/or rare diseases. A total of 27 regulatory‐led RWD studies have been conducted. Most studies were descriptive and aimed at estimating incidence and prevalence rates of clinical outcomes including adverse events or to evaluate medicines utilization. The review highlights key learnings to guide further efforts to enable the use and establish the value of real‐world evidence (RWE) for regulatory decisions. For instance, there is a need to access additional fit‐for‐purpose and representative data, and to explore further means to provide timely evidence that meets regulatory timelines. The need for early interactions and close collaboration with study requesters, e.g., from the Agency's scientific Committees, to better understand the research question is equally important. Finally, the review provides our perspective on the way forward to maximize the potential of regulatory‐led RWE generation. [ABSTRACT FROM AUTHOR]

Published
2024
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7. SJS/TEN 2019: From science to translation

Author

Chang, Wan-Chun, Abe, Riichiro, Anderson, Paul, Anderson, Wanpen, Ardern-Jones, Michael R., Beachkofsky, Thomas M., Bellón, Teresa, Biala, Agnieszka K., Bouchard, Charles, Cavalleri, Gianpiero L., Chapman, Nicole, Chodosh, James, Choi, Hyon K., Cibotti, Ricardo R., Divito, Sherrie J., Dewar, Karen, Dehaeck, Ulrike, Etminan, Mahyar, Forbes, Diane, Fuchs, Esther, Goldman, Jennifer L., Holmes, James H., IV, Hope, Elyse A., Hung, Shuen-Iu, Hsieh, Chia-Ling, Iovieno, Alfonso, Jagdeo, Julienne, Kim, Mee Kum, Koelle, David M., Lacouture, Mario E., Le Pallec, Sophie, Lehloenya, Rannakoe J., Lim, Robyn, Lowe, Angie, McCawley, Jean, McCawley, Julie, Micheletti, Robert G., Mockenhaupt, Maja, Niemeyer, Katie, Norcross, Michael A., Oboh, Douglas, Olteanu, Cristina, Pasieka, Helena B., Peter, Jonathan, Pirmohamed, Munir, Rieder, Michael, Saeed, Hajirah N., Shear, Neil H., Shieh, Christine, Straus, Sabine, Sukasem, Chonlaphat, Sung, Cynthia, Trubiano, Jason A., Tsou, Sheng-Ying, Ueta, Mayumi, Volpi, Simona, Wan, Chen, Wang, Hongsheng, Wang, Zhao-Qing, Weintraub, Jessica, Whale, Cindy, Wheatley, Lisa M., Whyte-Croasdaile, Sonia, Williams, Kristina B., Wright, Galen, Yeung, Sonia N., Zhou, Li, Chung, Wen-Hung, Phillips, Elizabeth J., and Carleton, Bruce C.

Published
2020
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13. COVID-19 Vaccines and Heavy Menstrual Bleeding:The Impact of Media Attention on Reporting to EudraVigilance

Author

Gordillo-Marañón, María, Szmigiel, Agnieszka, Yalmanová, Vladimíra, Caplanusi, Irina, Genov, Georgy, Olsen, David Benee, Straus, Sabine, Gordillo-Marañón, María, Szmigiel, Agnieszka, Yalmanová, Vladimíra, Caplanusi, Irina, Genov, Georgy, Olsen, David Benee, and Straus, Sabine

Abstract

Background and Objective: During the COVID-19 vaccination campaign, over 34,000 reports of heavy menstrual bleeding following the administration of COVID-19 vaccines originating in the Economic European Area were submitted to EudraVigilance, the European Union database of suspected adverse drug reactions. More than 90% of these reports were sent by consumers while the remaining by healthcare professionals. Public concerns regarding menstruation disorders in COVID-19 vaccinees were also covered by the media. We investigated the impact of media attention on the reporting trends of heavy menstrual bleeding to EudraVigilance. Methods: We used media outlets published in the Economic European Area on menstrual disorders and COVID-19 vaccines from the beginning of the vaccination campaign in the Economic European Area (1 January, 2021) until December 2022 (i.e., after the regulatory request to add the adverse event to the product information) and spontaneous reports from EudraVigilance. Results: We found that the publication of safety updates from regulatory authorities and subsequent coverage in media outlets preceded increased reporting to EudraVigilance. Furthermore, the heavy menstrual bleeding reported in the cases occurred several weeks or months earlier and were not submitted to the respective date. The analysis suggests that the spikes in reporting of heavy menstrual bleeding were to some extent influenced by media coverage in some countries. Conclusions: Consumer reporting to the European Union spontaneous data collection system, EudraVigilance, was of high value for regulatory safety reviews, albeit the reporting behaviours were not free of the influence of the media. These sources of information can be investigated to understand the context of safety concerns of public health interest.

Published
2024

14. Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines:Lessons Learnt and Recommendations

Author

Goedecke, Thomas, Martirosyan, Liana, Gault, Nathalie, Seifert, Karin, Morales, Daniel R, Bahri, Priya, Strassmann, Valerie, Huber, Martin, Straus, Sabine, Goedecke, Thomas, Martirosyan, Liana, Gault, Nathalie, Seifert, Karin, Morales, Daniel R, Bahri, Priya, Strassmann, Valerie, Huber, Martin, and Straus, Sabine

Abstract

Purpose: The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023. Methods: We surveyed PRAC Sponsors and (Co-)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision-making. Questions covered achievement of study objectives, risk minimisation effectiveness, added value for regulatory decision-making, and recommendations for future impact studies. Themes were generated using thematic content analysis. Results: Survey responses from 15 PRAC Sponsors and (Co-)Rapporteurs from 10 European Union Member States were included in the analysis. Among four cross-sectional surveys and eight drug utilisation studies, 50% achieved all objectives, the other studies partially due to limitations. Two studies concluded that risk minimisation measures were overall effective, two were effective with variation across countries, two were partially effective and four studies showed limited effectiveness. Two studies were deemed inconclusive due to limitations. The reasons for the limited effectiveness of risk minimisation may be explored using mixed-method approaches. Assessment of study feasibility and a priori discussion of effectiveness measurements is important. Conclusion: Despite limitations, impact research adds value to regulatory decision-making by addressing knowledge gaps and providing additional information on unintended consequences of regulatory interventions. Our recommendations will help to improve planning, conducting and interpretating future impact studies.

Published
2024

15. Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations.

Author

Goedecke, Thomas, Martirosyan, Liana, Gault, Nathalie, Seifert, Karin, Morales, Daniel R., Bahri, Priya, Strassmann, Valerie, Huber, Martin, and Straus, Sabine

Abstract

Purpose: The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023. Methods: We surveyed PRAC Sponsors and (Co‐)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision‐making. Questions covered achievement of study objectives, risk minimisation effectiveness, added value for regulatory decision‐making, and recommendations for future impact studies. Themes were generated using thematic content analysis. Results: Survey responses from 15 PRAC Sponsors and (Co‐)Rapporteurs from 10 European Union Member States were included in the analysis. Among four cross‐sectional surveys and eight drug utilisation studies, 50% achieved all objectives, the other studies partially due to limitations. Two studies concluded that risk minimisation measures were overall effective, two were effective with variation across countries, two were partially effective and four studies showed limited effectiveness. Two studies were deemed inconclusive due to limitations. The reasons for the limited effectiveness of risk minimisation may be explored using mixed‐method approaches. Assessment of study feasibility and a priori discussion of effectiveness measurements is important. Conclusion: Despite limitations, impact research adds value to regulatory decision‐making by addressing knowledge gaps and providing additional information on unintended consequences of regulatory interventions. Our recommendations will help to improve planning, conducting and interpretating future impact studies. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Author

Essink, Sharon C.M., Zomerdijk, Inge M., Straus, Sabine M.J.M., Gardarsdottir, Helga, De Bruin, Marie L., Essink, Sharon C.M., Zomerdijk, Inge M., Straus, Sabine M.J.M., Gardarsdottir, Helga, and De Bruin, Marie L.

Abstract

Introduction: In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union. Methods: We established a cohort of medicinal products with aRMMs at marketing authorisation (MA) that were centrally authorised from July 2012–December 2021 using the European Public Assessment Reports. Evaluation studies were identified from the Risk Management Plans at the time of MA. Subsequently, we retrieved protocols, final study reports, Pharmacovigilance Risk Assessment Committee (PRAC) assessment reports, and PRAC minutes. We calculated the probability of completing an effectiveness evaluation within 60 months after MA using time-to-event analyses. Besides, we compared the planned final report with the actual final report date. Results: We identified 134 medicinal products authorised with aRMMs, of which almost half (n = 63, 47.0%) had an effectiveness evaluation study. The probability of an evaluation for a medicinal product being completed within 60 months after MA was 20.7% (95% CI 6.8–32.6). Regarding study design, the probability of completing a study was higher for cross-sectional studies when compared to cohort studies (p = 0.002). Moreover, 81.0% of studies were delayed when compared to their planned final report date. Conclusion: The probability of completing an aRMM effectiveness evaluation at time for renewal of the MA was only one in five. Furthermore, estimates of the duration of studies around MA are too optimistic, with the majority being delayed.

Published
2023

20. Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, PECP - Centre for Pharmaceutical Policy and Regulation, Essink, Sharon C.M., Zomerdijk, Inge M., Straus, Sabine M.J.M., Gardarsdottir, Helga, De Bruin, Marie L., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, PECP - Centre for Pharmaceutical Policy and Regulation, Essink, Sharon C.M., Zomerdijk, Inge M., Straus, Sabine M.J.M., Gardarsdottir, Helga, and De Bruin, Marie L.

Published
2023

23. List of Contributors

Author

Ali, Ayad K., primary, Arana, Alejandro, additional, Baxter, Roger, additional, Blackburn, Stella, additional, Bohn, Justin, additional, Bosco, Jaclyn L.F., additional, Bryan, Philip, additional, Christian, Jennifer B., additional, Cid, Javier, additional, Cochino, Emil, additional, Cox, Andrew Paul, additional, Delaney, Joseph A.C., additional, Dreyer, Nancy A., additional, Fourrier-Reglat, Anne, additional, Fraeman, Kathy H., additional, Gagne, Joshua J., additional, Glynn, Robert J., additional, Goedcke, Thomas, additional, Haag, Mendel, additional, Hartzema, Abraham G., additional, Hazell, Lorna, additional, Jablonski, Rachel, additional, Jalbert, Jessica J., additional, Khromova, Alena, additional, Kurz, Xavier, additional, Lambrelli, Dimitra, additional, Layton, Deborah, additional, Lystig, Theodore C., additional, Mazzaglia, Giampiero, additional, Merinopoulou, Evie, additional, Nordstrom, Beth L., additional, Palucci, Ombretta, additional, Poole, Charles, additional, Rassen, Jeremy, additional, Reisinger, Stephanie, additional, Ritchey, Mary E., additional, Schneeweiss, Sebastian, additional, Seeger, John D., additional, Shakir, Saad, additional, Straus, Sabine, additional, Straus, Walter, additional, Toh, Sengwee, additional, Toussi, Massoud, additional, Velentgas, Priscilla, additional, Wang, Shirley V., additional, Wise, Lesley, additional, Wise, Robert P., additional, and Wyss, Richard, additional

Published
2018
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29. The Association of Serum Testosterone Levels and Ventricular Repolarization

Author

van Noord, Charlotte, Dörr, Marcus, Sturkenboom, Miriam C. J. M., Straus, Sabine M. J. M., Reffelmann, Thorsten, Felix, Stephan B., Hofman, Albert, Kors, Jan A., Haring, Robin, de Jong, Frank H., Nauck, Matthias, Uitterlinden, André G., Wallaschofski, Henri, Witteman, Jacqueline C. M., Völzke, Henry, and Stricker, Bruno H. Ch.

Published
2010
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42. Corrigendum to ‘SJS/TEN 2019: From science to translation’ [J. Dermatol. Sci. 98/1 (2020) 2–12]

Author

Chang, Wan-Chun, primary, Abe, Riichiro, additional, Anderson, Paul, additional, Anderson, Wanpen, additional, Ardern-Jones, Michael R., additional, Beachkofsky, Thomas M., additional, Bellón, Teresa, additional, Biala, Agnieszka K., additional, Bouchard, Charles, additional, Cavalleri, Gianpiero L., additional, Chapman, Nicole, additional, Chodosh, James, additional, Choi, Hyon K., additional, Cibotti, Ricardo R., additional, Divito, Sherrie J., additional, Dewar, Karen, additional, Dehaeck, Ulrike, additional, Etminan, Mahyar, additional, Forbes, Diane, additional, Fuchs, Esther, additional, Goldman, Jennifer L., additional, Holmes, James H., additional, Hope, Elyse A., additional, Hung, Shuen-Iu, additional, Hsieh, Chia-Ling, additional, Iovieno, Alfonso, additional, Jagdeo, Julienne, additional, Kim, Mee Kum, additional, Koelle, David M., additional, Lacouture, Mario E., additional, Le Pallec, Sophie, additional, Lehloenya, Rannakoe J., additional, Lim, Robyn, additional, Lowe, Angie, additional, McCawley, Jean, additional, McCawley, Julie, additional, Micheletti, Robert G., additional, Mockenhaupt, Maja, additional, Niemeyer, Katie, additional, Norcross, Michael A., additional, Oboh, Douglas, additional, Olteanu, Cristina, additional, Pasieka, Helena B., additional, Peter, Jonathan, additional, Pirmohamed, Munir, additional, Rieder, Michael, additional, Saeed, Hajirah N., additional, Shear, Neil H., additional, Shieh, Christine, additional, Straus, Sabine, additional, Sukasem, Chonlaphat, additional, Sung, Cynthia, additional, Trubiano, Jason A., additional, Tsou, Sheng-Ying, additional, Ueta, Mayumi, additional, Volpi, Simona, additional, Wan, Chen, additional, Wang, Hongsheng, additional, Wang, Zhao-Qing, additional, Weintraub, Jessica, additional, Whale, Cindy, additional, Wheatley, Lisa M., additional, Whyte-Croasdaile, Sonia, additional, Williams, Kristina B., additional, Wright, Galen, additional, Yeung, Sonia N., additional, Zhou, Li, additional, Chung, Wen-Hung, additional, Phillips, Elizabeth J., additional, and Carleton, Bruce C., additional

Published
2021
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