Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (Critical Issues in Health and Medicine)

Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (Critical Issues in Health and Medicine)

Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (Critical Issues in Health and Medicine)

Pharmaceutical Clinical Trials
Pharmaceutical Clinical Trials

 

Today, more than 75 percent of Pharmaceutical Clinical Trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important Pharmaceutical Clinical Trials are now being outsourced to non-academic physicians.
According to Jill A. Fisher, this major change in the wayPharmaceutical Clinical Trials are performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report dimini

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What are Pharmaceutical Clinical Trials?

Pharmaceutical Clinical Trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization or a clinical trials unit in the academic sector.

 

Pharmaceutical Clinical Trials

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