Clinical Research Methodology

The purposes of several key components of clinical research methodology can be summarized as follows (Turner 2012) ... 

Arani RB, Soong S-1, Weiss HL, Wood Ml et al. (2001) Phase specific analysis of herpes zoster associated pain data a new statistical approach Statistics in Medicine, 20, 2429-2439 Bedikian AY, MiUward M, Pehamberger H, Conry R et al. (2006) Bcl-2 Antisense (obUmersen sodium) plus dacarbazine in patients with advanced melanoma The ObUmersen Melanoma Study Group Journal of Clinical Oncology, 24, 4738-4745 Bland M (2004) Cluster randomised trials in the medical Uterature two bibliometric surveys BMC Medical Research Methodology, 4, 21... 

At this level a number of methodological issues concerning clinical research need to be addressed ... 

Kraemer, H.C. Methodological and statistical progress m psychiatric clinical research a statistician s perspective In Bloom, F.E., Rupfer, DJ. Psvchopharmacologv the Fourth Generation of Progress. Raven Press, New York, 1994, pp. 1849-1860. 

There are two components to evidence-based medicine and two related sets of responsibilities. The first component is clinical research. Clinical research is a scientific endeavor that provides evidence concerning potential therapeutic interventions. This book has focused on one particular therapeutic intervention, drug therapy. Once clinical trials have been conducted, the evidence obtained is published in clinical communications in journals. Everyone involved in clinical research has the responsibility to provide the best possible evidence in this manner. As noted throughout the book, this includes all aspects of clinical research study design, experimental methodology and clinical operations, analysis and interpretation, and also accurate and complete representation of study findings in clinical communications as discussed in Section 13.6. 

From the scientific perspective, an inappropriate study design is generally incapable of answering a research question, no matter how careful the subsequent methodology and analysis. Additionally, the perfect design will not provide optimum information if the research methodology is flawed or an inappropriate statistical analysis is conducted. From the ethical perspective, research subjects voluntarily take part in clinical trials with the understanding that their participation... 

In the past complementary therapies have been called alternative or fringe medicine but the position of conflict between complementary and conventional therapies is outdated. The term allopathic is used for the conventional, orthodox mainstream medicine and relies on gathering evidence through scientific research methodology. It examines outcomes, i.e. the results or consequences that follow from the action or intervention that we call the treatment. There is a clinical criterion called the gold standard clinical variable, which is often viewed as the measure of clinical improvement in a condition. This can be a simple quantitative measure for some conditions, e.g. blood sugar level for diabetes, peak air flow for asthmatics. Often there are multiple variables and simple quantitative criteria are inapplicable. 

M Linden. Phase IV clinical research specifics, objectives and methodology. Pharmacopsychiatry 17 162-167, 1984. 

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