Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can divert investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, ther...

The state of Louisiana, like the nation as a whole, is facing the salient challenge of improving population health and efficiency of healthcare delivery. Research to inform innovations in healthcare will best enhance this effort if it is timely, efficient, and patient-centered. The Louisiana Clinical Data Research Network (LACDRN) will increase the capacity to conduct robust comparative effecti...

BACKGROUND Governments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In t...

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve pa...

whAt Is the PRoBleM? Different from trials for regulatory approvals of new interventions aimed to test the efficacy, comparative effectiveness research (CER) is the direct comparison of existing health‐care interventions (compared with active controls) to examine which treatment works best, for whom, and under what settings.[1] Therefore, CER is indispensable to assist consumers, clinicians, pu...

This article traces the history and evolution of statistics in the era of evidence based medicine, and focuses on the Indian perspective of this growth of statistics as a discipline for clinical research. Statistics will assume a more inter disciplinary form. Use of software other than SAS likely to grow further. In India, innovative statistical methods will help propel the development of biosi...

Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory...

BACKGROUND Multiple classifications have been developed that classify the medical literature into different levels of evidence to facilitate the evaluation of study results and practice of evidence-based medicine. The suggested hierarchies of evidence are generally based on the type of study design; randomized, controlled clinical trials constitute the top level of evidence while case reports r...

I N 1914 Abel2 described the technic of plasmapheresis in animals and demonstrated that very large amounts of plasma could be withdrawn if the red cells were re-transfused. Since that time, the technic of plasmapheresis has l)een used extensively in the research laboratory for the study of protein metabolism and more recently has been introduced as an alternate form of l)lOod donation in humans...

While physical and human capital are established as important predictors of success among early-career clinical investigators, less is known about the role of social capital. The authors aimed to develop a brief scale to assess social capital in this population and test its reliability and validity. A three-item assessment was developed based on a conceptual framework and measures of social cap...