Contemporary clinical trials
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Contemp Clin Trials · Nov 2013
ReviewAn industry statistician's perspective on PHC drug development.
In the past decade, the cost of drug development has increased significantly. The estimates vary widely but frequently quoted numbers are staggering-it takes 10-15 years and billions of dollars to bring a drug to patients. To a large extent this is due to many long, expensive and ultimately unsuccessful drug trials. ⋯ We will present guiding principles of personalized health care (PHC) development and review the statistical, strategic, regulatory and operational challenges that statisticians regularly encounter on development programs with a PHC component. Some practical recommendations for team statisticians involved in PHC drug development are included. The majority of the examples and recommendations are drawn from oncology but broader concepts apply across all therapeutic areas.
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Contemp Clin Trials · Jul 2013
ReviewA systematic review of the factors influencing African Americans' participation in cancer clinical trials.
This systematic review was conducted to synthesize the existing evidence regarding key considerations influencing African Americans' participation in cancer clinical trials (CCTs). ⋯ Existing research underscores the importance of social support from family and friends, cultural appropriateness and sensitivity from physicians and in the design of the CCT, and enhanced education among African Americans in decision-making processes. As African Americans are underrepresented in CCTs, targeted strategies to enhance recruitment efforts and improve cancer treatment outcomes are essential.
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Contemp Clin Trials · Jul 2013
ReviewA systematic review of the factors influencing African Americans' participation in cancer clinical trials.
This systematic review was conducted to synthesize the existing evidence regarding key considerations influencing African Americans' participation in cancer clinical trials (CCTs). ⋯ Existing research underscores the importance of social support from family and friends, cultural appropriateness and sensitivity from physicians and in the design of the CCT, and enhanced education among African Americans in decision-making processes. As African Americans are underrepresented in CCTs, targeted strategies to enhance recruitment efforts and improve cancer treatment outcomes are essential.
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Contemp Clin Trials · Sep 2012
ReviewDoes the reporting of randomized clinical trials published in Chinese pediatrics journals improve after the CONSORT Statement is adopted?
There is no systematic assessment whether the quality of reporting has been improved since the CONSORT Statement was introduced into China in 1997. The aim of this study is to determine whether the use of the CONSORT Statement is associated with improved quality of reporting of RCTs published in Chinese pediatrics journals. ⋯ The quality of reporting of RCTs has not significantly improved since the CONSORT Statement was introduced into China. The reporting remains poor, and often inadequate for assessment of the rigor of studies. Chinese pediatrics journals should reinforce the use of the CONSORT Statement in the reporting of trials.
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Contemp Clin Trials · Jul 2012
ReviewEarly phase drug development for treatment of chronic pain--options for clinical trial and program design.
Due to high prevalence and unmet medical need, chronic pain has become an important area for development of new medicines. Chronic pain disorders are heterogeneous with regard to pathophysiological mechanisms and clinical presentation. While a mechanism-based classification of pain is generally advocated, it is not yet applicable for diagnostic use. ⋯ We have reviewed characteristics of three alternative design options from an early (Phase 2) drug development perspective; enriched enrolment, dose titration and adaptive dosing. The advantages and disadvantages of each type of study design were analyzed and discussed from a clinical development program perspective. It is concluded that these designs can be useful in addressing different types of issues in early development of novel analgesic drugs for chronic pain.