The logic behind the RCT research design seems unassailable. Before the efficacy of a new drug is actually tested, it is only theoretical. Even the most promising results from laboratory experiments and animal studies cannot always be replicated in humans. Reliable testing must ensure that drug effects are observed in a representative sample of patients [...]
INTRODUCTION The touchstone of clinical research is the randomized controlled trial (RCT). This is the design preferred for studies that face academic scrutiny through peer review, and it is the required research paradigm for findings that are submitted to the Food and Drug Administration (FDA) to support New Drug Applications (NDAs). The probative value as [...]
This secondary analysis of patients is from the first randomized head-to-head clinical trial that was designed and powered to evaluate the efficacy of EPO 40,000 units once weekly versus DARB 200 mcg every two weeks. The DCR point estimate was 199:1 in the base case scenario, with a tight range of 190:1 to 207:1, depending [...]
Study Population Of the 358 subjects enrolled in the trial, 352 received at least one dose of study drug and had at least one post-baseline Hb reading or transfusion; these patients formed the modified intent-to-treat (mITT) population. For our analysis, six subjects (three receiving EPO and three receiving DARB) were further excluded because they lacked [...]
Study Population This secondary retrospective analysis used data from an open-label, randomized, multicenter, head-to-head trial comparing EPO and DARB. To be included in the trial, patients had to be histologically confirmed solid malignancy baseline hemoglobin level of 11 g/dl or lower cyclic chemotherapy scheduled for a minimum of 12 weeks informed consent obtained fewer than [...]
INTRODUCTION Anemia is a common complication of myelosuppressive chemotherapies in patients with cancer. When untreated, chemotherapy-induced anemia (CIA) may adversely affect the patient’s quality of life and ability to function because of symptoms such as fatigue, weakness, shortness of breath, and impaired mental function.
Presenter: James Berenson, MD, Medical and Scientific Director, Institute for Myeloma and Bone Cancer Research, West Hollywood, California Multiple myeloma (MM) is an incurable B-cell malignancy, and resistance develops in nearly all patients. Most patients develop renal insufficiency, which is associated with poor survival.
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