A standardised framework to identify optimal animal models for efficacy assessment in drug development.

Autor: Guilherme S Ferreira, Désirée H Veening-Griffioen, Wouter P C Boon, Ellen H M Moors, Christine C Gispen-de Wied, Huub Schellekens, Peter J K van Meer

Publikováno v: PLoS ONE, Vol 14, Iss 6, p e0218014 (2019)

IntroductionPoor translation of efficacy data derived from animal models can lead to clinical trials unlikely to benefit patients-or even put them at risk-and is a potential contributor to costly and unnecessary attrition in drug development.Objectiv

Externí odkaz: https://doaj.org/article/0f14ca084e9b487cb8a1f7e01b4a38f6

Regulatory scientific advice on non-inferiority drug trials.

Autor: Grace Wangge, Michelle Putzeist, Mirjam J Knol, Olaf H Klungel, Christine C Gispen-De Wied, Antonius de Boer, Arno W Hoes, Hubert G Leufkens, Aukje K Mantel-Teeuwisse

Publikováno v: PLoS ONE, Vol 8, Iss 9, p e74818 (2013)

The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin. Regulatory guidelines provi

Externí odkaz: https://doaj.org/article/41f4581e6bd243c9827bd962f70ffa8c

Gender differences in the response to antipsychotic medication in patients with schizophrenia: An individual patient data meta-analysis of placebo-controlled studies

Autor: Bram W.C. Storosum, Taina Mattila, Tamar D. Wohlfarth, Christine C. Gispen-de Wied, Kit C.B. Roes, Wim van den Brink, Lieuwe de Haan, Damiaan A.J.P. Denys, Jasper B. Zantvoord

Publikováno v: Psychiatry research, 320. Elsevier Ireland Ltd
Psychiatry Research, 320
Psychiatry research, 320:114997. Elsevier Ireland Ltd

Contains fulltext : 291389.pdf (Publisher’s version ) (Open Access) OBJECTIVE: To determine whether gender and menopausal status moderate the response to antipsychotic medication in patients with schizophrenia. METHODS: We analyzed data of 22 short

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b9e87144925089575d8f46721c207bb
https://pure.knaw.nl/portal/en/publications/a58eae0c-484c-4225-9cc3-2785050a4d15

Run‐in periods and clinical outcomes of antipsychotics in dementia: A meta‐epidemiological study of placebo‐controlled trials

Autor: Hendrika J Luijendijk, Tessa A. Hulshof, Christine C. Gispen-de Wied, Sytse U Zuidema

Publikováno v: Pharmacoepidemiology and Drug Safety

Purpose Run‐in periods are used to identify placebo‐responders and washout. Our aim was to assess the association of run‐in periods with clinical outcomes of antipsychotics in dementia. Methods We searched randomized placebo‐controlled trials

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::652f9fc4a7c6d517cad99d403a8ce391
http://europepmc.org/articles/PMC7027584

Oncologic orphan drugs approved in the EU - do clinical trial data correspond with real-world effectiveness?

Autor: Christine C. Gispen-de Wied, Carla E. M. Hollak, Yvonne Schuller, Violeta Stoyanova-Beninska, Heinz-Josef Klümpen, Marieke Biegstraaten

Publikováno v: Orphanet Journal of Rare Diseases
Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-11 (2018)
Orphanet journal of rare diseases, 13(1):214. BioMed Central
Orphanet Journal of Rare Diseases, 13(1):214. BioMed Central
Schuller, Y, Biegstraaten, M, Hollak, C E M, Klümpen, H-J, Gispen-de Wied, C C & Stoyanova-Beninska, V 2018, ' Oncologic orphan drugs approved in the EU-Do clinical trial data correspond with real-world effectiveness? ', Orphanet Journal of Rare Diseases, vol. 13, no. 1, 214 . https://doi.org/10.1186/s13023-018-0900-9

Background Evaluation of evidence for efficacy of orphan medicinal products (OMPs) for rare malignancies may be hampered by the use of tumor measurements instead of clinical endpoints. This may cause efficacy data to not always match effectiveness in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3f5a0f5dd39833986a83556b4da85f21
https://pubmed.ncbi.nlm.nih.gov/30486835