The reporting of harms in publications on randomized controlled trials funded by the 'Programme Hospitalier de Recherche Clinique,' a French academic funding scheme

Autor: Romain Favier, Sabrina Crépin

Publikováno v: Clinical Trials. 15:257-267

Background/aims: Accurate information on harms arising from medical interventions is essential for assessing benefit–risk ratios. Since 2004, there has been an extension of the Consolidated Standards of Reporting Trials statement for reporting harm

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a5ee601e8ff6849a0919a30a66a304c
https://doi.org/10.1177/1740774518760565

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

Autor: Sabrina Crépin, Louis Merle, Claire Villeneuve

Publikováno v: Pharmacoepidemiology and Drug Safety. 25:719-724

Purpose The purpose of this study is to evaluate the quality of the serious adverse events (SAE) reported to an academic sponsor. Assessing the safety of a clinical trial relies on information gathering the collection of adverse events reported by th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::8dbf0e02b7cf0eb2485da2f787892d32
https://doi.org/10.1002/pds.3982

[Reporting of harms in clinical trials: Vigilant support to the investigator. A guideline of REVISE' Group]

Autor: Henri, Marfin, Sophie, Fedrizzi, Sabrina, Crépin, Jean-Jacques, Parienti, Anne, Gimbert, Violaine, Blandamour, Alpha, Diallo, Gilles, Defer, Delphine, Bertram, Laure, Peyro Saint Paul

Publikováno v: Therapie. 71(5)

Since August 9, 2004, the 2001 European Directive for clinical trials is applied to the French law. Since the 2006 implementing decree amending public health law on biomedical researches, safety data are managed by sponsor vigilant. Competent authori

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::ab6d9c7fa221b564f7a4672d6fedd2e7
https://pubmed.ncbi.nlm.nih.gov/27423828

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

Autor: Sabrina, Crépin, Claire, Villeneuve, Louis, Merle

Publikováno v: Pharmacoepidemiology and drug safety. 25(6)

The purpose of this study is to evaluate the quality of the serious adverse events (SAE) reported to an academic sponsor. Assessing the safety of a clinical trial relies on information gathering the collection of adverse events reported by the invest

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::07e930c4acc0536c9a2d935de774c9b5
https://pubmed.ncbi.nlm.nih.gov/26887649

Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database

Autor: Sabrina Crépin, Pierre Petit, Jean-Louis Montastruc, Samy Babai, Virginie Bres, Hervé Le Louet, Dominique Hillaire-Buys, Jean-Luc Faillie, Marie-Laure Laroche

Publikováno v: Acta Diabetologica
Acta Diabetologica, 2013, 51 (3), pp.491-497. ⟨10.1007/s00592-013-0544-0⟩
Acta Diabetologica, Springer Verlag, 2013, epub ahead of print. ⟨10.1007/s00592-013-0544-0⟩

International audience; : In the recent past, concerns have raised regarding the potential risk of acute pancreatitis among type 2 diabetic patients using incretin-based drugs such as glucagon-like peptide 1 (GLP-1) analogs and dipeptidyl peptidase 4

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ca2b1fd77fbb3737e869941eed7d0e21
https://hal-unilim.archives-ouvertes.fr/hal-00922480/document