Adverse Event Reporting in Clinical Trials: Time to Include Duration as Well as Severity
نویسندگان
چکیده
منابع مشابه
Adverse Event Reporting in Clinical Trials: Time to Include Duration as Well as Severity
Assessing the efficacy of therapy involves a complex interplay between the risks and benefits within particular patient populations. The concept of patient benefit has been well established. Direct patient benefits are typically assessed with regard to patients living longer, living better, or both. Assessing risks of therapy can be more difficult. To properly assess risks, one must have a clea...
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Regulatory and ethical guidelines require clinical trial sponsors to disseminate clinical trial adverse event reports to involved investigators and human research ethics committees. Compliance with these guidelines has resulted in a major administrative burden for ethics committees. This burden does not necessarily contribute to the protection of clinical trial participants. Rationalisation of ...
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ژورنال
عنوان ژورنال: The Oncologist
سال: 2017
ISSN: 1083-7159,1549-490X
DOI: 10.1634/theoncologist.2017-0437