Carmen Polito

Navigating the institutional review board approval process in a multicenter observational critical care study.

Objective:To characterize variation in the institutional review board application process of a multicenter, observational critical care study. Design, Setting, and Subjects:Survey analysis of 36 investigators who applied for participation in the United States Critical Illness and Injury Trials Group: Critical Illness and Outcomes Study, an observational study of 69 adult ICUs. Interventions:None. Measurements and Main Results:Analysis of investigator-specific characteristics, institutional review board process, application and approval dates, and level of difficulty in obtaining approval. Surveys were analyzed from 36 sites (95%) that applied for institutional review board approval. Level of review ranged from full board, expedited, to exempt. Seventy-five percent of applications were submitted by an experienced investigator while 25% were submitted by a less experienced investigator. Median time to institutional review board approval was 30 days (interquartile range, 14–54) and ranged from 5 days to 5.5 months. Time to approval was 29 days (interquartile range, 17–48) for applications submitted by an experienced investigator compared with 97 days (interquartile range, 25–159) for those submitted by a less experienced investigator (p = 0.08). Subjective level of difficulty was significantly higher for less experienced investigators (4 of 10; interquartile range, 2–8) vs experienced investigators (2 of 10; interquartile range, 1–3) (p = 0.04). Four sites cited institutional review board concern regarding waiver of consent as a major barrier to approval and were required to perform revisions or participate in board meetings regarding this concern. Conclusions:In a multicenter, observational critical care study, significant variation was observed between sites in all aspects of the institutional review board evaluation and approval process. The level of difficulty was significantly higher for less experienced investigators with a trend toward longer time to institutional review board approval. Variation in institutional review board interpretation of waiver of informed consent regulations was cited as a major barrier to approval.

Rare Elizabethkingia meningosepticum meningitis case in an immunocompetent adult

Though Elizabethkingia meningosepticum typically causes meningitis in neonates, its occurrence in adult is rare, with sixteen cases described worldwide. We report a case of E. meningosepticum meningitis in an immunocompetent adult. Bacterial identification was made a day earlier than conventional method by using matrix assisted laser desorption ionization time-of-flight (MALDI-TOF) Vitek mass spectrometry RUO (VMS), which resulted in successful treatment with rifampin, trimethoprim-sulfamethoxazole, levofloxacin and minocycline.

Developing a World Class Clinical Trial Site

Developing a World Class Clinical Trial Site: A Step by Step Guide for Developing a Clinical Trial Site by P. K. Julka. 2011 Field Creation of a clinical trial site with a focus on drug development. Format Paperback and Kindle eBook available for purchase online. Audience Inexperienced clinical investigators. Purpose Overview of the clinical trial process from design to publication. Content This book is organized into 26 brief chapters that serve as a broad overview of the development of a clinical trial site. Important trial design and implementation concepts, such as review of ethical requirements, creation of standard operating procedures, composition of the study team, infrastructure requirements, and trial monitoring, are provided in pithy and easy-to-follow text. The flow charts and graphics included throughout the book are clear and mostly helpful, and each chapter concludes with several summary points. The last few chapters include templates for common documents, including clinical study reports and publications. Strengths The book is easy to navigate and covers many major topics of interest to novice clinical investigators. Limitations and Weaknesses Although the short book covers many topics that are useful for trial site initiation, the focus of book’s content is on drug discovery and development, with little guidance on other types of clinical trials. It is also primarily designed for inexperienced investigators and would not serve the needs of those investigators who have previously participated in clinical trials. In addition, subjects such as observational trials, implementation science, and investigator-initiated studies are not covered in this textbook. The book also appears biased toward the development of clinical trial sites in India, which may prove annoying to investigators from other locations. Finally, this edition has content unchanged from the 2009 book but has a new title and publication date. Competing Products • Friedman, Furberg, and DeMets. Fundamentals of Clinical Trials. 2010. • Liu and Davis. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. 2010. • Brody. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. 2011. • Meinert C. Clinical Trials: Design, Conduct and Analysis, 2nd ed. 2012. Funding Not reported.