Radiologists Urge FDA To Accept PET-Based Tumor Response Criteria in Clinical Trials
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منابع مشابه
Evidence Based Medicine: Clinical Trials
Evidence based medicine is very important for success of modern medicine. It is the ongoing process of using the most reliable evidence from clinical studies, scientific understanding and medical practice to make the best possible medical choice for patients. Evidence based medicine is how medicine advances and how we get improvements in life expectancy and quality of life. It not only identifi...
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Drug Administration (FDA) has been interested in the individualization of therapy, that is, determining whether and how treatment should be modified for various demographic groups within the population. After several years of discussion, a guideline was published on the study of drugs in the elderly (1), and later a similar guideline on the study and evaluation of gender differences in the clin...
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Standardized staging and response assessment are critical to the successful conduct of clinical trials. In turn, clinical trials are essential to the development of new and more effective therapy for patients with lymphomas. In the absence of effective agents, response criteria are almost irrelevant. However, with the increasing number of effective therapies, standardized criteria are necessary...
متن کاملBiologics clinical trials, research, and FDA actions.
Hopes raised, hopes dashed — the last half of 2012 has seen plenty of both. Enthusiasm over a bumper crop of U.S. Food and Drug Administration approvals has been tempered by a long list of phase 3 trial disappointments. Oncology agents led the way, starting with two drugs being studied for the treatment of non-small cell lung cancer. The addition of Eli Lilly’s pemetrexed (Alimta) to a regimen ...
متن کاملFDA draft guidance on computerised systems used in clinical trials.
When using computer systems to manage clinical studies, it is important to understand how these systems should be controlled and, for studies intended to support United States (US) regulatory submissions, when and how US regulations on electronic records and signatures apply. This article discusses these issues and a draft guidance document.
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ژورنال
عنوان ژورنال: JNCI: Journal of the National Cancer Institute
سال: 2011
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/djr133