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Levels of Evidence for Adult Cancer Treatment Studies (PDQ®)
Health Professional VersionEn EspañolLast Modified: 05/19/2004




Introduction






Strength of Study Design






Strength of Endpoints






Summary






Changes to This Summary (05/19/2003)






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Introduction

A variety of endpoints may be measured and reported from clinical studies in oncology. These may include total mortality (or survival from the initiation of therapy), cause-specific mortality, quality of life, or indirect surrogates of these 3 outcomes, such as disease-free survival, progression-free survival, or tumor response rate. Endpoints may also be determined within study designs of varying strength, ranging from the gold standard—the randomized, double-blinded controlled clinical trial—to case series experiences from nonconsecutive patients. The PDQ editorial boards use a formal ranking system of levels of evidence to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. For any given therapy, results can be ranked on each of the following two scales: (1) strength of the study design and (2) strength of the endpoints. Together, the two rankings give an idea of the overall level of evidence. Depending on perspective, different expert panels, professional organizations, or individual physicians may use different “cut points” of overall strength of evidence in formulating therapeutic guidelines or in taking action; however, a formal description of the level of evidence provides a uniform framework for the data, leading to specific recommendations.

The PDQ Adult Treatment Editorial Board adds information on levels of evidence, described below, to the PDQ adult treatment cancer information summaries when appropriate.

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