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Your search keyword '"Mol, Peter G. M."' showing total 347 results
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347 results on '"Mol, Peter G. M."'

4. Do efficacy results obtained from randomized controlled trials translate to effectiveness data from observational studies for relapsing–remitting multiple sclerosis?

Author

Verweij, Stefan, primary, Ahmed, Wouter, additional, Zhou, Guiling, additional, Mavridis, Dimitris, additional, Nikolakopoulos, Stavros, additional, Elferink, Andre J., additional, Rengerink, Katrien Oude, additional, Bijlsma, Maarten J., additional, Mol, Peter G. M., additional, and Hak, Eelko, additional

Published
2024
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8. Modified Delphi procedure-based expert consensus on endpoints for an international disease registry for Metachromatic Leukodystrophy: The European Metachromatic Leukodystrophy initiative (MLDi)

Author

Schoenmakers, Daphne H., Beerepoot, Shanice, van den Berg, Sibren, Adang, Laura, Bley, Annette, Boelens, Jaap-Jan, Fumagalli, Francesca, Goettsch, Wim G., Grønborg, Sabine, Groeschel, Samuel, van Hasselt, Peter M., Hollak, Carla E. M., Lindemans, Caroline, Mochel, Fanny, Mol, Peter G. M., Sevin, Caroline, Zerem, Ayelet, Schöls, Ludger, and Wolf, Nicole I.

Published
2022
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9. Real-World Overall Survival after Alternative Dosing for Pembrolizumab in the Treatment of Non-Small Cell Lung Cancer: A Nationwide Retrospective Cohort Study with a Non-Inferiority Primary Objective

Author

Grit, Geeske F., primary, van Geffen, Esmée, additional, Malmberg, Ruben, additional, van Leeuwen, Roelof W. F., additional, Böhringer, Stefan, additional, Smit, Hans J. M., additional, Brocken, Pepijn, additional, Eijsink, Job F. H., additional, Dronkers, Esther, additional, Gal, Pim, additional, Jaarsma, Eva, additional, van Drie-Pierik, Regine J. H. M., additional, Eldering-Heldens, Anne M. P., additional, Wymenga, Machteld A. N., additional, Mol, Peter G. M., additional, Zwaveling, Juliëtte, additional, and Hilarius, Doranne L., additional

Published
2024
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11. Glucagon-like peptide-1 receptor agonists use and associations with outcomes in heart failure and type 2 diabetes: data from the Swedish Heart Failure and Swedish National Diabetes Registries

Author

Wallner, Markus, Biber, Mattia Emanuele, Stolfo, Davide, Sinagra, Gianfranco, Benson, Lina, Dahlström, Ulf, Gudbjörnsdottir, Soffia, Cosentino, Francesco, Mol, Peter G M, Rosano, Giuseppe M C, Butler, Javed, Metra, Marco, Lund, Lars H, Ferrannini, Giulia, and Savarese, Gianluigi

Abstract

Graphical Abstract

Published
2024
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22. The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy's multi-stakeholder preconvention questionnaire.

Author

Van Haesendonck, Lauren, Ruof, Jörg, Desmet, Thomas, Van Dyck, Walter, Simoens, Steven, Huys, Isabelle, Giuliani, Rosa, Toumi, Mondher, Dierks, Christian, Dierks, Juliana, Cardone, Antonella, Houÿez, Francois, Pavlovic, Mira, Berntgen, Michael, Mol, Peter G. M., Schiel, Anja, Goettsch, Wim, Gianfrate, Fabrizio, Capri, Stefano, and Ryan, James

Subjects
MEDICAL technology, SELF-evaluation, QUESTIONNAIRES, SELF-perception, TECHNOLOGY assessment
Abstract

Involvement of all relevant stakeholders will be of utmost importance for the success of the developing EU HTA harmonization process. A multi-step procedure was applied to develop a survey across stakeholders/collaborators within the EU HTA framework to assess their current level of involvement, determine their suggested future role, identify challenges to contribution, and highlight efficient ways to fulfilling their role. The 'key' stakeholder groups identified and covered by this research included: patients', clinicians', regulatory, and Health Technology Developer representatives. The survey was circulated to a wide expert audience including all relevant stakeholder groups in order to determine self-perception by the 'key' stakeholders regarding involvement in the HTA process (self-rating), and in a second, slightly modified version of the questionnaire, to determine the perception of 'key' stakeholder involvement by HTA bodies, payers, and policymakers (external rating). Predefined analyses were conducted on the submitted responses. Fifty-four responses were received (patients9; clinicians: 8; regulators: 4; HTDs 14; HTA bodies: 7; Payers: 5; policymakers 3; others 4). The mean self-perceived involvement score was consistently lower for each of the 'key' stakeholder groups than the respective external ratings. Based on the qualitative insights generated in the survey, a RACI Chart (Responsible/Accountable/Consulted/Informed) was developed for each of the stakeholder groups to determine their roles and involvement in the current EU HTA process. Our findings suggest extensive effort and a distinct research agenda are required to ensure adequate involvement of the key stakeholder groups in the evolving EU HTA process. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Eligibility for sotagliflozin in a real-world heart failure population based on the SOLOIST-WHF trial enrolment criteria: data from the Swedish heart failure registry

Author

Becher, Peter Moritz, primary, Savarese, Gianluigi, additional, Benson, Lina, additional, Dahlström, Ulf, additional, Karlström, Patric, additional, Mol, Peter G M, additional, Metra, Marco, additional, Bhatt, Deepak L, additional, Pitt, Bertram, additional, and Lund, Lars H, additional

Published
2023
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29. Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK

Author

de Vries, Sieta T., Denig, Petra, Andrić, Adriana, Dimov Di Giusti, Marina, Ptaszynska-Neophytou, Alicia, Härmark, Linda, Mol, Peter G. M., the IMI Web-RADR Work Package 3b Consortium and SCOPE Joint Action Work Package, and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)

Subjects
medicine.medical_specialty, Activities of daily living, Drug-Related Side Effects and Adverse Reactions, MEDICAL PRACTITIONERS, Croatia, MEDLINE, Toxicology, Agency (sociology), Medicine, Adverse Drug Reaction Reporting Systems, Humans, Pharmacology (medical), Drug reaction, Original Research Article, Netherlands, Pharmacology, Descriptive statistics, Health professionals, business.industry, VIEWS, Survey research, ATTITUDINAL SURVEY, United Kingdom, Adr reporting, Family medicine, PHARMACOVIGILANCE SYSTEM, business, MOBILE APP, Delivery of Health Care
Abstract

Introduction Healthcare professionals (HCPs) and patients have various motives to report adverse drug reactions (ADRs) to their national agency. These motives may differ between countries. Objective The aim of this study was to assess to what extent motives of HCPs and patients to report ADRs differ between countries. Methods HCPs and patients from Croatia (HR), The Netherlands (NL), and the UK were asked to complete a web-based survey containing questions regarding demographics and ADR reporting. HCPs and patients could select all motives for reporting that applied to them, with a total of 23 and 24 motives, respectively. Descriptive statistics are presented and Chi-square tests were used to test for differences across the countries, with effect sizes calculated using Cramer’s V. Results In total, 296 HCPs and 423 patients were included (60% and 32% from Croatia, 19% and 44% from NL, and 21% and 24% from the UK, respectively). For most of the motives to report or not to report an ADR, there were no differences between countries. Most HCPs from all countries would be motivated to report an ADR if there was a strong suspicion of causality (89%), if it concerned a severe/serious ADR (86%), and if it concerned an ADR for a new, recently marketed drug (77%). Most patients from all countries agreed that they would report an ADR if it concerned a severe ADR (96%), if the ADR influenced their daily activities (91%), and if they were worried about their own situation (90%). Differences across the countries (p

Published
2021

31. Aandacht voor vrouwen in geneesmiddelenonderzoek

Author

de Vries, Sieta, Vrijlandt, Patrick, Havinga, Ineke K., and Mol, Peter G. M.

Abstract

Vrouwen werden in het verleden vaak uitgesloten van deelname aan klinische geneesmiddelenstudies. Gaandeweg is de aandacht voor vrouwen in deze studies toegenomen. Dit heeft geleid tot veranderingen in beleid. Tegenwoordig wordt in richtlijnen aangegeven dat een onderzoekspopulatie representatief moet zijn voor de beoogde gebruiker van het geneesmiddel, wat betreft leeftijd, geslacht en andere belangrijke kenmerken. Ook moeten subgroepanalyses naar onder andere geslacht uitgevoerd worden. Uit recent onderzoek blijkt dan ook dat er aandacht is voor vrouwen in geneesmiddelenstudies; zo is geslachtsspecifieke informatie beschikbaar over farmacokinetiek, effectiviteit en veiligheid van de onderzochte geneesmiddelen. Toch is er ruimte voor verbetering, onder andere op het gebied van de vertegenwoordiging van vrouwen in bepaalde ziektegebieden. Bij de beoordeling van geneesmiddelen wordt gekeken naar mogelijke effectverschillen tussen mannen en vrouwen. Meestal worden er geen klinisch relevante verschillen gevonden. Wanneer dit wel zo is, worden geslachtsspecifieke behandeladviezen opgesteld. Het is belangrijk dergelijke geslachtsverschillen in behandeladviezen in de praktijk op te volgen en waar mogelijk nog niet bekende verschillen te signaleren om te komen tot een optimale behandeling van elke individuele patiënt.

Published
2022

32. Additional file 1 of Modified Delphi procedure-based expert consensus on endpoints for an international disease registry for Metachromatic Leukodystrophy: The European Metachromatic Leukodystrophy initiative (MLDi)

Author

Schoenmakers, Daphne H., Beerepoot, Shanice, van den Berg, Sibren, Adang, Laura, Bley, Annette, Boelens, Jaap-Jan, Fumagalli, Francesca, Goettsch, Wim G., Gr��nborg, Sabine, Groeschel, Samuel, van Hasselt, Peter M., Hollak, Carla E. M., Lindemans, Caroline, Mochel, Fanny, Mol, Peter G. M., Sevin, Caroline, Zerem, Ayelet, Sch��ls, Ludger, and Wolf, Nicole I.

Abstract

Additional file 1: Search strings. Additional information about literature review

Published
2022
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33. Additional file 2 of Modified Delphi procedure-based expert consensus on endpoints for an international disease registry for Metachromatic Leukodystrophy: The European Metachromatic Leukodystrophy initiative (MLDi)

Author

Schoenmakers, Daphne H., Beerepoot, Shanice, van den Berg, Sibren, Adang, Laura, Bley, Annette, Boelens, Jaap-Jan, Fumagalli, Francesca, Goettsch, Wim G., Gr��nborg, Sabine, Groeschel, Samuel, van Hasselt, Peter M., Hollak, Carla E. M., Lindemans, Caroline, Mochel, Fanny, Mol, Peter G. M., Sevin, Caroline, Zerem, Ayelet, Sch��ls, Ludger, and Wolf, Nicole I.

Abstract

Additional file 2: Flow chart. Additional information about literature review.

Published
2022
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34. Additional file 4 of Modified Delphi procedure-based expert consensus on endpoints for an international disease registry for Metachromatic Leukodystrophy: The European Metachromatic Leukodystrophy initiative (MLDi)

Author

Schoenmakers, Daphne H., Beerepoot, Shanice, van den Berg, Sibren, Adang, Laura, Bley, Annette, Boelens, Jaap-Jan, Fumagalli, Francesca, Goettsch, Wim G., Gr��nborg, Sabine, Groeschel, Samuel, van Hasselt, Peter M., Hollak, Carla E. M., Lindemans, Caroline, Mochel, Fanny, Mol, Peter G. M., Sevin, Caroline, Zerem, Ayelet, Sch��ls, Ludger, and Wolf, Nicole I.

Abstract

Additional file 4: Complete core and optional set of data elements. Complete lists of data elements.

Published
2022
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35. Additional file 3 of Modified Delphi procedure-based expert consensus on endpoints for an international disease registry for Metachromatic Leukodystrophy: The European Metachromatic Leukodystrophy initiative (MLDi)

Author

Schoenmakers, Daphne H., Beerepoot, Shanice, van den Berg, Sibren, Adang, Laura, Bley, Annette, Boelens, Jaap-Jan, Fumagalli, Francesca, Goettsch, Wim G., Gr��nborg, Sabine, Groeschel, Samuel, van Hasselt, Peter M., Hollak, Carla E. M., Lindemans, Caroline, Mochel, Fanny, Mol, Peter G. M., Sevin, Caroline, Zerem, Ayelet, Sch��ls, Ludger, and Wolf, Nicole I.

Abstract

Additional file 3: Levels of evidence and Summary tables literature review. Levels of Evidence according to The Oxford Centre for Evidence-based Medicine. Level 6 was added to take the input from patients and caregivers into account. Summary table of reviewed full texts.

Published
2022
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37. Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making.

Author

Bakker, Elisabeth, Plueschke, Kelly, Jonker, Carla J., Kurz, Xavier, Starokozhko, Viktoriia, and Mol, Peter G. M.

Subjects
DECISION making, GOVERNMENT agencies, CLINICAL medicine, DRUGS, MARKETING, RISK perception
Abstract

Real‐world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE to demonstrate efficacy requires further evaluation. This study aimed to (i) characterize RWD/RWE presented by applicants to support claims on medicines' efficacy within initial marketing authorization applications (MAAs) and extension of indication applications (EoIs), and (ii) analyze the contribution of RWD/RWE to regulatory decisions on medicines' benefit–risk profile. RWD/RWE was included to support efficacy in 32 MAAs and 14 EoIs submitted 2018–2019. Of these, RWD/RWE was part of the preauthorization package of 16 MAAs and 10 EoIs, and was (i) considered supporting the regulatory decision in 10 applications (five MAAs, five EoIs), (ii) considered not supporting the regulatory decision in 11 (seven MAAs, four EoIs), and (iii) not addressed at all in the evaluation of 5 applications (four MAAs, one EoI). Common limitations of submitted RWD/RWE included missing data, lack of representativeness of populations, small sample size, absence of an adequate or prespecified analysis plan, and risk of several types of bias. The suitability of RWD/RWE in a given application still requires a case‐by‐case analysis considering its purpose of use, implying reflection on the data source, together with its assets and limitations, study objectives and designs, and the overall data package issued. Early interactions and continuous dialogues with regulators and relevant stakeholders is key to optimize fit‐for‐purpose RWE generation, enabling its broader use in medicines development. [ABSTRACT FROM AUTHOR]

Published
2023
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42. Healthcare professionals' level of medication knowledge in Africa: a systematic review

Author

Berhe, Derbew Fikadu, Taxis, Katja, Haaijer‐Ruskamp, Flora M., Mol, Peter G. M., PharmacoTherapy, -Epidemiology and -Economics, and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)

Subjects
Pharmacology, Health Knowledge, Attitudes, Practice, Drug Therapy, Systematic Review and Meta‐analysis, Health Personnel, education, Africa, Outcome Assessment, Health Care, Humans, healthcare professionals, medication knowledge
Abstract

OBJECTIVE: Understanding how much healthcare professionals (HCPs) know about medication can help to devise strategies to improve rational medication use. This study aimed to synthesis information on the level of medication knowledge of HCPs in Africa. METHOD: We performed a systematic literature study in Embase and PubMed. We included original studies quantifying HCPs' medication knowledge, published between 2012 and 2016. We extracted disease focus, country, number and type of HCPs included and all medication-related knowledge questions and scored the quality of papers. The outcome measure was the percentage HCPs who correctly answered medication knowledge questions. RESULTS: We identified 64 studies from 12 African countries, comprising 13,911 HCPs, mostly nurses/midwifes and physicians. We extracted 306 medication-related knowledge questions, and only 52% (SD 28) of HCPs correctly answered them. Knowledge questions were mainly about medication prescribed for communicable diseases (70%), followed by non-communicable diseases (11%), and family Planning/Gynecology (10%). Most papers concluded that there was a considerable medication knowledge gap among HCPs. CONCLUSION: We found a low level of medication knowledge across different disease areas, countries and HCPs. This underlines the continuous need to strengthen the undergraduate and postgraduate education in (clinical) pharmacology and therapeutics in Africa.

Published
2018

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