Resource implications of preparing individual participant data from a clinical trial to share with external researchers.
Trials
; 18(1): 319, 2017 07 17.
Article
em En
| MEDLINE
| ID: mdl-28712359
ABSTRACT
BACKGROUND:
Demands are increasingly being made for clinical trialists to actively share individual participant data (IPD) collected from clinical trials using responsible methods that protect the confidentiality and privacy of clinical trial participants. Clinical trialists, particularly those receiving public funding, are often concerned about the additional time and money that data-sharing activities will require, but few published empirical data are available to help inform these decisions. We sought to evaluate the activity and resources required to prepare anonymised IPD from a clinical trial in anticipation of a future data-sharing request.METHODS:
Data from two UK publicly funded clinical trials were used for this exercise 2437 participants with epilepsy recruited from 90 hospital outpatient clinics in the SANAD trial and 146 children with neuro-developmental problems recruited from 18 hospitals in the MENDS trial. We calculated the time and resources required to prepare each anonymised dataset and assemble a data pack ready for sharing.RESULTS:
The older SANAD trial (published 2007) required 50 hours of staff time with a total estimated associated cost of £3185 whilst the more recently completed MENDS trial (published 2012) required 39.5 hours of staff time with total estimated associated cost of £2540.CONCLUSIONS:
Clinical trial researchers, funders and sponsors should consider appropriate resourcing and allow reasonable time for preparing IPD ready for subsequent sharing. This process would be most efficient if prospectively built into the standard operational design and conduct of a clinical trial. Further empirical examples exploring the resource requirements in other settings is recommended. TRIAL REGISTRATION SANAD International Standard Randomised Controlled Trials Registry ISRCTN38354748 . Registered on 25 April 2003. MENDS EU Clinical Trials Register Eudract 2006-004025-28 . Registered on 16 May 2007. International Standard Randomised Controlled Trials Registry ISRCTN05534585 /MREC 07/MRE08/43. Registered on 26 January 2007.Palavras-chave
Texto completo:
1
Temas:
ECOS
/
Aspectos_gerais
Bases de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Coleta de Dados
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Ensaios Clínicos como Assunto
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Disseminação de Informação
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Fluxo de Trabalho
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Trials
Assunto da revista:
MEDICINA
/
TERAPEUTICA
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Reino Unido