6 results match your criteria Clinical Research and Regulatory Affairs [Journal]

  • Page 1 of 1

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

Clin Res Regul Aff 2016 1;33(2-4):25-32. Epub 2016 Jun 1.

Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.

Context: Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings.

Objective: We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Read More

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http://dx.doi.org/10.1080/10601333.2016.1182693DOI Listing
June 2016
33 Reads

Reflections on the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Process-Findings from a Qualitative Study.

Clin Res Regul Aff 2015 Oct 18;32(4):121-130. Epub 2015 Sep 18.

Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.

Context: The context for this study was the Adaptive Designs Advancing Promising Treatments Into Trials (ADAPT-IT) project, which aimed to incorporate flexible adaptive designs into pivotal clinical trials and to conduct an assessment of the trial development process. Little research provides guidance to academic institutions in planning adaptive trials.

Objectives: The purpose of this qualitative study was to explore the perspectives and experiences of stakeholders as they reflected back about the interactive ADAPT-IT adaptive design development process, and to understand their perspectives regarding lessons learned about the design of the trials and trial development. Read More

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http://dx.doi.org/10.3109/10601333.2015.1079217DOI Listing
October 2015
30 Reads

Special population considerations and regulatory affairs for clinical research.

Clin Res Regul Aff 2015;32(2):47-56

Division of Adolescent Medicine, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.

Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. Read More

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http://dx.doi.org/10.3109/10601333.2015.1001900DOI Listing
January 2015
27 Reads

Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel.

Clin Res Regul Aff 2015 Mar;32(1):22-35

Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA.

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Read More

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http://dx.doi.org/10.3109/10601333.2015.980944DOI Listing
March 2015
10 Reads

Adaptive designs for comparative effectiveness research trials.

Clin Res Regul Aff 2015 13;32(1):36-44. Epub 2014 Nov 13.

Department of Health Outcomes and Policy, University of Florida, Gainesville, FL, USA.

Context: Medical and health policy decision makers require improved design and analysis methods for comparative effectiveness research (CER) trials. In CER trials, there may be limited information to guide initial design choices. In general settings, adaptive designs (ADs) have effectively overcome limits on initial information. Read More

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http://dx.doi.org/10.3109/10601333.2014.977490DOI Listing
November 2014
12 Reads

Disposition kinetics of a dipeptide ester prodrug of acyclovir and its metabolites following intravenous and oral administrations in rat.

Clin Res Regul Aff 2009 Jan;26(3):65-72

Division of Pharmaceutical Sciences, School of Pharmacy, University of Missouri-Kansas City, Kansas City, Missouri, USA.

The objective of this work was to study the disposition kinetics of valine-valine-acyclovir (VVACV), a dipeptide ester prodrug of acyclovir following intravenous and oral administrations in rat. A validated LC-MS/MS analytical method was developed for the analysis VVACV, Valine-Acyclovir (VACV), and Acyclovir (ACV) using a linear Ion Trap Quadrupole. ACV was administered orally for comparison purpose. Read More

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http://dx.doi.org/10.1080/10601330903200684DOI Listing
January 2009
11 Reads
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