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The possible relationship of an adverse event to use of study product is assessed by the investigator. The terminology for these assessments can vary from one reporting system to the next. The DMID (S)AE reporting system uses the following terms to describe the relationship of an AE to the study product.
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Reporting rules for adverse events in clinical trials only seem straightforward in the case of death or injury requiring hospitalization. Otherwise, those involved in clinical trials have to figure out how soon they need to report, what information needs to be included in the report, and who should get it.
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While an argument could be made that collecting genetic information from individuals is no different from collecting any other type of health information, the fact remains that the very word genetic may raise additional concerns among potential research participants.
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The brave new world of genetics and pharmacogenetics research provides some exciting possibilities as well as some major challenges to researchers. Recruiting subjects is top concern.
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In January, New Jersey became only the second state in the union to pass legislation formally permitting research using embryonic stem cells.
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Exemestane after Tamoxifen Therapy in Breast Cancer; An Analysis of How Long Patients Remain on Various BP Therapies; Endothelial Dysfunction with Insulin Resistance and CWT in Hypertension
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A clinical prediction rule helps identify patients with knee pain who might benefit from orthopedic surgery.
