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2017 ; 18
(1
): 319
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Resource implications of preparing individual participant data from a clinical
trial to share with external researchers
#MMPMID28712359
Tudur Smith C
; Nevitt S
; Appelbe D
; Appleton R
; Dixon P
; Harrison J
; Marson A
; Williamson P
; Tremain E
Trials
2017[Jul]; 18
(1
): 319
PMID28712359
show ga
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.
|*Research Design
[MESH]
|*Workflow
[MESH]
|Clinical Trials as Topic/economics/*methods/organization & administration
[MESH]