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Clinical Research

  • Race & Ethnicity in Clinical Research

    Posted on 3/4/2015 12:40 PM

    Defining the Problem The role of race and ethnicity in biomedical research is constantly under debate. After sequencing the human genome and mapping human genetic variations, there are contradictory beliefs and practices about the use of race and ethnicity in clinical research. These beliefs and practices endorse the concept of a socially constructed race and ethnicity, yet at the same time they are often treated as genetic variables. Is it scientifically correct to treat race and ethnicity as

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  • Expanding the Discussion: Assessing CV Safety in Clinical Research

    Posted on 2/25/2014 4:30 PM

    Clinical drug trials are always challenged with creating clear, standardized definitions of cardiovascular (CV) event outcomes that can be easily agreed-upon and evaluated by regulatory agencies. As data from several different clinical trials are frequently compiled to gain a fuller understanding of the investigational drug, it is important to use definitions that can be recognized across various studies. CV endpoints currently being examined in clinical studies are usually based off of a custom

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  • Modern Approaches to Assessing CV Safety in Clinical Drug Research

    Posted on 1/28/2014 4:32 PM

    Cardiovascular (CV) events have always been a prime focus in clinical drug research, but have been of increased concern to the FDA in recent years. In 2007, a well-publicized meta-analysis by Nissen and Wolski identified an increased risk of myocardial infarction and death due to CV causes associated with the anti-diabetic drug rosiglitazone1. The FDA Endocrinologic and Metabolic Drugs Advisory Committee met in July 2008 and determined that concerns about CV risks during premarketing and postmar

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  • Combination Therapy: The Path Revealed

    Posted on 9/26/2013 10:51 AM

    The recent advance in the understanding of the pathophysiological process behind some of the most common life-threatening diseases, such as cancer and AIDS, has warranted the need to develop new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets. Combination therapy is a method to treat a disease or a disorder through the simultaneous usage of different drugs having synergistic or additive potential to improve therapeutic efficacy. The final guideline

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  • Are Pharmaceutical Companies Mainstreaming Nutraceuticals?

    Posted on 3/7/2013 11:56 AM

    The term nutraceutical is a word that was coined by Stephen DeFelice, MD in the early 1990’s. Dr. DeFelice is the founder and chairman of the Foundation for Innovation in Medicine in Cranford, NJ. Nutraceutical is a combination of the words “nutrition” and “pharmaceutical” and Dr. DeFelice meant it to describe any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease. Today it is a commonly accepted word in the l

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  • Herbal Medicine in Clinical Trials: Regulation and Challenges

    Posted on 8/2/2012 12:05 PM

    According to the World Health Organization (WHO), traditional medicine refers to health practices, approaches, knowledge, and beliefs incorporating plant, animal, and mineral based medicines, spiritual therapies, manual techniques, and exercises, applied singularly or in combination to treat, diagnose, and prevent illnesses or to maintain well-being. If the material being used is of plant origin, then it is called traditional herbal medicines. In the Chinese pharmacopoeia (2005 edition), nearly

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  • CDISC SDTM Programming: Utility Programs and Scope of Code Reusability

    Posted on 6/28/2012 12:33 PM

    The Idea Writing SAS programs for SDTM conversion could be a cumbersome process when the raw data are not CDASH compliant or is a legacy data that did not follow any particular standard for data capture (in CRF and during Data Entry into a designed DBMS screen). This task could be simplified to a great extent if clinical programmers have utility macros (substitution of programming lines) handy with them. Let us see how and why utility macros may be used. Utility macros Fine Tunes Programming T

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  • Pharmacovigilance Trends: Getting to Know the DSUR

    Posted on 6/21/2012 12:40 PM

    In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. Although both the Food & Drug Administration (FDA) and EU Clinical Trial Directive required what is termed as IND AR and ASR, respectively, the conte

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