In our June/July issue:
PEER-REVIEWED ARTICLES
Left to Our Own Devices
Bill Byrom, Jeff Lee, Kara Dennis, Matthew Noble, Marie McCarthy, Willie Muehlhausen
Industry concerns have limited the use of the "Bring Your Own Device" (BYOD) approach for electronic clinical outcome assessment in clinical trials. Authors, through the results of a three-month survey, uncover the challenges and myths associated with BYOD adoption—information they hope can drive future strategies in this area.
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Informed Consent: The Digital Directive
Jeffrey Litwin, MD
With increasing focus today on shedding traditional clinical study designs for more "patient-centric" models, this paper makes the case for electronic informed consent as a key cog in supporting this transformation and the onset of a new era of patient recruitment and engagement.
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RBM Tool Chest: Raising the Bar
Penelope K. Manasco, MD
There is more and more evidence demonstrating the advantages of direct data entry and risk-based monitoring (RBM) to oversee study conduct quality. This report takes an in-depth look at those technology solutions best poised to provide significant benefits to implementing RBM and remote trial management.
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NEWS
View From Washington: Jill Wechsler provides a status update on FDA's breakthrough drug program—the progress and cautions.
View From Brussels: Peter O'Donnell reports on the turned-up spotlight globally on tackling antibiotic resistance through R&D.
Global Report: Philip Ward details new efforts in Europe to solve the problem of low involvement of older people in clinical trials.
Data Analysis: Survey reveals mixed, if not underwhelming, adoption of paperless data collection methods in clinical studies.
Information Technology: Amid push for electronic health record data in clinical trials, can integrating EHR and eSource be on the horizon?
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CLINICAL TRIAL INSIGHTS
The eClinical Challenge for Sites
Ken Getz
New survey reveals that sites are often burdened by unmet technology needs and limited use of eClinical systems—pointing to the importance of "solutions" that understand site workflow and optimize site performance. |
CLOSING THOUGHT
eSource Emergence: Quality Matters
Jules Mitchel
eSource data integration in clinical studies will provide challenges to data quality, so it's critical to involve regulators in this process. |
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