Briefly, matrix management of Phase IV studies relates to the use of a
matrix management organizational structure to conduct Phase IV
studies. Phase IV studies are conducted in the pharmaceutical
industry, and are geared toward the monitoring of pharmaceuticals
after they have been approved by the FDA (in the United States) and
are being prescribed. They look for problems and efficacy. The
concept of a national Phase IV study simply implies the geographic
area over which data is being obtained and analyzed.
I hope you find the following references and quotations helpful.
Wonko
http://www.strategicfutures.com/articles/matrix/mtrx-1.htm
Ronald A. Gunn, Matrix Management: Method, Not Magic, Strategic
Futures
Matrix Management is an organizational model organizing teams in the
functional elements of an organization. An example is diagrammed
here: http://www.strategicfutures.com/articles/matrix/mtrx-4.htm
http://www.strategicfutures.com/articles/matrix/mtrx-7.htm
"Let's see how this plays out in a live example, drawn from, say
pharmaceutical R&D. Peter is a biostatistician who is currently
assigned to 3 separate cross-functional drug teams. He "reports" to
three Project Team Directors as well as to the head of his functional
department, the Vice President for Biostatistical Research."
In this case, Peter is part of a matrix structure, wherein he is the
intersection point between three separate project teams and the
biostatistical research department. He is being subjected to matrix
management because he reports into projects and functional areas.
http://www.cochrane.dk/cochrane/handbook/hbookPhase_IV_studies.htm
"Phase IV studies
Studies that are concerned with post-marketing surveillance. They are
often promotional exercises aimed at bringing a new drug to the
attention of a large number of clinicians, and may be of limited
scientific value." |