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Anonymising and sharing individual patient data.
El Emam K, Rodgers S, Malin B. El Emam K, et al. BMJ. 2015 Mar 20;350:h1139. doi: 10.1136/bmj.h1139. BMJ. 2015. PMID: 25794882 Free PMC article.
There is a strong movement to share individual patient data for secondary purposes, particularly for research. A major obstacle to broad data sharing has been the concern for patient privacy. One of the methods for protecting the p …
There is a strong movement to share individual patient data for secondary purposes, particularly for research. A …
FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma.
Sahin U, Türeci Ö, Manikhas G, Lordick F, Rusyn A, Vynnychenko I, Dudov A, Bazin I, Bondarenko I, Melichar B, Dhaene K, Wiechen K, Huber C, Maurus D, Arozullah A, Park JW, Schuler M, Al-Batran SE. Sahin U, et al. Ann Oncol. 2021 May;32(5):609-619. doi: 10.1016/j.annonc.2021.02.005. Epub 2021 Feb 19. Ann Oncol. 2021. PMID: 33610734 Free article. Clinical Trial.
Zolbetuximab, a chimeric monoclonal antibody, mediates specific killing of CLDN18.2-positive cells through immune effector mechanisms. PATIENTS AND METHODS: The FAST study enrolled advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients …
Zolbetuximab, a chimeric monoclonal antibody, mediates specific killing of CLDN18.2-positive cells through immune effector mechanisms. PA …
Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol.
Teng YKO, Bruce IN, Diamond B, Furie RA, van Vollenhoven RF, Gordon D, Groark J, Henderson RB, Oldham M, Tak PP. Teng YKO, et al. BMJ Open. 2019 Mar 20;9(3):e025687. doi: 10.1136/bmjopen-2018-025687. BMJ Open. 2019. PMID: 30898822 Free PMC article.
Major secondary efficacy endpoints are the proportion of patients in clinical remission (defined as SLEDAI-2K=0, without immunosuppressants and corticosteroids) at week 64, and the proportion of patients with disease control at week 104. Safety endpoints include the …
Major secondary efficacy endpoints are the proportion of patients in clinical remission (defined as SLEDAI-2K=0, without immunosuppre …
Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach.
Hughes S, Wells K, McSorley P, Freeman A. Hughes S, et al. Pharm Stat. 2014 May-Jun;13(3):179-83. doi: 10.1002/pst.1615. Epub 2014 Mar 25. Pharm Stat. 2014. PMID: 24668938
In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific researchers to request access to anonymised patient level clinical trial data. Providing access to individual …
In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific r …
The prognostic profile of subfertile couples and treatment outcome after expectant management, intrauterine insemination and in vitro fertilisation: a study protocol for the meta-analysis of individual patient data.
van den Boogaard NM, Hompes PG, Barnhart K, Bhattacharya S, Custers IM, Coutifaris C, Goverde AJ, Guzick DS, Litvak PF, Steures PN, van der Veen F, Bossuyt P, Mol BW. van den Boogaard NM, et al. BJOG. 2012 Jul;119(8):953-7. doi: 10.1111/j.1471-0528.2012.03343.x. Epub 2012 May 18. BJOG. 2012. PMID: 22607482 Review.
Individual patient data analyses allow us to take these prognostic factors into account, and to evaluate their effect on treatment outcome. This study aims to use anonymised data from relevant published trials to perform an individual …
Individual patient data analyses allow us to take these prognostic factors into account, and to evaluate their effect o …
Efficacy and moderators of efficacy of trauma-focused cognitive behavioural therapies in children and adolescents: protocol for an individual participant data meta-analysis from randomised trials.
de Haan A, Hitchcock C, Meiser-Stedman R, Landolt MA, Kuhn I, Black MJ, Klaus K, Patel SD, Fisher DJ, Dalgleish T. de Haan A, et al. BMJ Open. 2021 Feb 24;11(2):e047212. doi: 10.1136/bmjopen-2020-047212. BMJ Open. 2021. PMID: 33627356 Free PMC article.
To overcome the issue of limited power, an individual participant data meta-analysis of randomised trials evaluating forms of trauma-focused cognitive behavioural therapy in children and adolescents aged 6-18 years will be conducted. ...ETHICS AND DISSEMINATION: Con …
To overcome the issue of limited power, an individual participant data meta-analysis of randomised trials evaluating forms of …
Response to physical rehabilitation and recovery trajectories following critical illness: individual participant data meta-analysis protocol.
Jones JRA, Berney S, Berry MJ, Files DC, Griffith DM, McDonald LA, Morris PE, Moss M, Nordon-Craft A, Walsh T, Gordon I, Karahalios A, Puthucheary Z, Denehy L; CRITICALConnect Study Investigators. Jones JRA, et al. BMJ Open. 2020 May 4;10(5):e035613. doi: 10.1136/bmjopen-2019-035613. BMJ Open. 2020. PMID: 32371516 Free PMC article.
Principal investigators of eligible trials were invited to contribute their data to this individual participant data meta-analysis. Risk of bias will be assessed (Cochrane risk of bias tool for randomised trials). ...Multiple imputation using chained equation …
Principal investigators of eligible trials were invited to contribute their data to this individual participant data me …
Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository.
Tudur Smith C, Dwan K, Altman DG, Clarke M, Riley R, Williamson PR. Tudur Smith C, et al. PLoS One. 2014 May 29;9(5):e97886. doi: 10.1371/journal.pone.0097886. eCollection 2014. PLoS One. 2014. PMID: 24874700 Free PMC article.
BACKGROUND: Calls have been made for increased access to individual participant data (IPD) from clinical trials, to ensure that complete evidence is available. ...Restricted access requiring approval, data security, anonymisation of data, and ov …
BACKGROUND: Calls have been made for increased access to individual participant data (IPD) from clinical trials, to ensure tha …
International severe asthma registry (ISAR): protocol for a global registry.
FitzGerald JM, Tran TN, Alacqua M, Altraja A, Backer V, Bjermer L, Bjornsdottir U, Bourdin A, Brusselle G, Bulathsinhala L, Busby J, Canonica GW, Carter V, Chaudhry I, Cho YS, Christoff G, Cosio BG, Costello RW, Eleangovan N, Gibson PG, Heaney LG, Heffler E, Hew M, Hosseini N, Iwanaga T, Jackson DJ, Jones R, Koh MS, Le T, Lehtimäki L, Ludviksdottir D, Maitland-van der Zee AH, Menzies-Gow A, Murray RB, Papadopoulos NG, Perez-de-Llano L, Peters M, Pfeffer PE, Popov TA, Porsbjerg CM, Price CA, Rhee CK, Sadatsafavi M, Tohda Y, Wang E, Wechsler ME, Zangrilli J, Price DB. FitzGerald JM, et al. BMC Med Res Methodol. 2020 Aug 14;20(1):212. doi: 10.1186/s12874-020-01065-0. BMC Med Res Methodol. 2020. PMID: 32819285 Free PMC article.
Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's co …
Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. …
Living labs for patient engagement and knowledge exchange: an exploratory sequential mixed methods study to develop a living lab in paediatric rehabilitation.
Archibald MM, Wittmeier K, Gale M, Ricci F, Russell K, Woodgate RL. Archibald MM, et al. BMJ Open. 2021 May 4;11(5):e041530. doi: 10.1136/bmjopen-2020-041530. BMJ Open. 2021. PMID: 33947723 Free PMC article.
ANALYSIS: Inductive thematic analysis using interpretive description, integrated analysis of visual data and descriptive and content analysis of e-survey data will be undertaken. ...A parent advisory group and rehabilitation engineering partners will confer on da …
ANALYSIS: Inductive thematic analysis using interpretive description, integrated analysis of visual data and descriptive and content …
68 results