Quality clinical

The principal role of the CRO is to contribute to the enhancement of the financial performance of its customers (Table 21.1). Improvement in the efficiency of their clients product development activities provides benefits to regulators, physicians and their patients. These include reduced cycle time, availability of external capacity, increased quality of trial management, and higher quality clinical data, all of which can result in lower labor costs. In late stage peri-approval trials, CROs may also play a role in developing safety profiles in large patient populations that are exposed to a new product after it is approved for manufacture and sale. Such trials can also assist the revenue growth of a new product. 

It is remarkable that, despite decades of accumulated observational evidence, the balance of benefits and harms for hormone use in healthy postmenopausal women remains uncertain (8). Quite apart from the constantly changing spectrum of the available data, one explanation for the confusion is the relatively high proportion of poor-quality clinical work, particularly studies that are designed to promote particular commercialized forms of treatment from among the many alternatives available. 

ShekeUe PG, Ortiz E, Rhodes S, Morton SC, Eccles MP, Grimshaw JM, Woolf SH. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines how quickly do guidelines become outdated JAMA 2001 286 1461-7. 

Clinical trials cannot take place without an infrastructure designed to support the research function. With research studies becoming more complex and entailing more procedures per subject (Figure 11.3), it is critical that the staff at the investigative site have an appreciation of what it takes to perform good-quality clinical research in a timely, ethical and fiscally responsible manner. 

The initial draft of the template was evaluated at four hospitals under the direction of clinical pharmacy administrators. The evaluators noted several advantages of the template for example, it could lead to quality clinical... 

The medical literature is perhaps the best indexed and most readily accessible of all information types in science and technology. The National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM) was a leader in creating an online, high-quality clinical database to complement its venerable multi volume Index Medicus. NLM s... 

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY CLINICAL PRACTICE GUIDELINE TREATING TOBACCO USE AND DEPENDENCE... 

In Part 3, Cohen focuses on the American Cancer Society and its blacklist of alternative therapies. For starters, he cites an article by Andrew Vickers titled Alternative Cancer Cures Unproven or Disproven in the March/April 2004 issue of CA — A Cancer Journal for Clinicians, a publication of the American Cancer Society. Vickers is described as an Assisting Attending Research Methodologist at Memorial Sloan-Kettering Cancer Center. Asserting that many alternative cancer treatments have been investigated in good quality clinical trials, Vickers states that... 

The performance of high-quality clinical cough research requires not only meticulous attention to the cough challenge procedure itself, but also an appreciation of issues relevant to study population, placebo effects, and proper interpretation of study data. 

Quality and Safety in Healthcare American Journal of Medical Quality International Journal of Healthcare Quality Assurance Journal of Quality Clinical Practice Journal of the American Medical Association New England Journal of Medicine The Lancet... 

It is decided to focus the risk assessment on two qualities clinical need of the medicine and uniqueness of distributor. Each quality may be scored as acceptable, relevant or critical. 

For the quality clinical need of the medicine the team decides to score as follows ... 

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