[Show abstract][Hide abstract] ABSTRACT: Mobile health (mHealth) approaches for non-communicable disease (NCD) care seems particularly applicable to sub-Saharan Africa given the penetration of mobile phones in the region. The evidence to support its implementation has not been critically reviewed.
Globalization and Health 06/2014; 10(1):49. · 1.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigators were asked to (1) prospectively document time to process IND safety reports and (2) retrospectively review safety reports from a previous 3-month period, documenting resultant actions. In this limited sample, sites spent a median of 0.25 hours per report at a median cost of US$22. Few expedited safety reports were retrospectively said to have changed study conduct or informed consent. However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results. The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements. Better methods to facilitate this type of research will enrich the scientific basis of future clinical trial regulation and guidance.
Therapeutic Innovation and Regulatory Science 07/2014; 48(4):413-419.
[Show abstract][Hide abstract] ABSTRACT: For privacy and practical reasons, it is sometimes necessary to minimize sharing of individual-level information in multisite studies. However, individual-level information is often needed to perform more rigorous statistical analysis.
Medical Care 07/2014; 52(7):664-8. · 2.94 Impact Factor
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