Guide to Clinical Trials

SPILKER B (1991) Guide to clinical trials, New York, Raven Press. 

Spilker, B. (1991). Guide to Clinical Trials. Raven Press, New York. 

Spilker, B. Monitoring a clinical trial. In Guide to Clinical Trials Lippincott-Raven Philadelphia, 1996 430-448. 

In the case of a new sensor and if possible, the preferred approach to clinical trials is to select an already approved assay for the same parameter which is already on the market. In this case, all data on the approved assay (including the 510(k) or PM A application) can be used to guide clinical studies and claimed indications for the new sensor. 

Definitions given below apply to the words as used in this Guide. They may have different meanings in other contexts. An additional glossary of terms relating to clinical trials is provided in Annex 13, Manufacture of investigational medicinal products. 

While taking Serp-1 to clinical trial is a first step in the path toward using viral anti-inflammatory proteins as a new therapeutic, this work really represents only the first step in our symphony and our first passage in the study of serpins as guides to new therapeutic modalities. 

AL Dans, LF Dans, GH Guyatt, S Richardson. Users guides to the medical literature XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA 279 545-549, 1998. 

Drug Products for Clinical Trials An International Guide to Formulation Production Quality Control, edited by Donald C. Monkhouse and Christopher T. Rhodes... 

Specific criteria to indicate treatment failure have not been established through controlled clinical trials. As a general guide, the following events should prompt consideration for changing therapy ... 

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