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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
Current recommendations/practices for anonymising data from clinical trials in order to make it available for sharing: A scoping review.
Rodriguez A, Tuck C, Dozier MF, Lewis SC, Eldridge S, Jackson T, Murray A, Weir CJ. Rodriguez A, et al. Clin Trials. 2022 Aug;19(4):452-463. doi: 10.1177/17407745221087469. Epub 2022 Jun 22. Clin Trials. 2022. PMID: 35730910 Free PMC article.
BACKGROUND/AIMS: There are increasing pressures for anonymised datasets from clinical trials to be shared across the scientific community, and differing recommendations exist on how to perform anonymisation prior to sharing. ...Anonymised datase …
BACKGROUND/AIMS: There are increasing pressures for anonymised datasets from clinical trials to be shared across the scientifi …
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 …
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. ...ETHICS AND DISSEMINATION: …
Major secondary efficacy endpoints are the proportion of patients in clinical remission (defined as SLEDAI-2K=0, without immunosuppre …
Association between relative age at school and persistence of ADHD in prospective studies: an individual participant data meta-analysis.
Synergy for the Influence of the Month of Birth in ADHD (SIMBA) study group. Synergy for the Influence of the Month of Birth in ADHD (SIMBA) study group. Lancet Psychiatry. 2023 Dec;10(12):922-933. doi: 10.1016/S2215-0366(23)00272-9. Epub 2023 Oct 25. Lancet Psychiatry. 2023. PMID: 37898142 Free article.
Relative age was recorded as the month of birth in relation to the school-entry cutoff date. Study authors were invited to share raw data or to apply a script to analyse data locally and generate anonymised results. ...FINDINGS: Of 33 119 studies gener …
Relative age was recorded as the month of birth in relation to the school-entry cutoff date. Study authors were invited to share raw …
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 …
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
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 …
Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review.
Wilmes N, Hendriks CWE, Viets CTA, Cornelissen SJWM, van Mook WNKA, Cox-Brinkman J, Celi LA, Martinez-Martin N, Gichoya JW, Watkins C, Bakhshi-Raiez F, Wynants L, van der Horst ICC, van Bussel BCT. Wilmes N, et al. BMJ Glob Health. 2023 May;8(5):e012007. doi: 10.1136/bmjgh-2023-012007. BMJ Glob Health. 2023. PMID: 37257937 Free PMC article.
With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data anonymisation, data sharing and data transfer as proxies for study quality. ...Ethical approval was describe …
With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data
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