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P&S Journal

P&S Journal: Fall 1995, Vol.15, No.3
Clinical Trials: Recruitment, Sometimes Easy Sometimes a Thankless Task. The Adventures of Six Clinicians Recruiting Patients for Trials By Lynne Christensen;
The Clinical Trials Process

Drug Approval
Before new drugs are approved by the Food and Drug Administration and made widely available, they must pass through a rigorous series of trials. Once a compound is identified in the laboratory as having potential therapeutic value, it is subjected to preclinical trials, which involve extensive laboratory and animal testing. The goal of these studies is to determine whether the compound is biologically active and safe.

If the compound proves effective in preclinical trials, human clinical testing can begin. Clinical trials are conducted in three phases.

Approval for Procedures
New procedures are not as strictly regulated by government agencies as drugs. However, a therapy that has shown promise usually undergoes clinical trials because most physicians wait for widespread acceptance of a new procedure after sufficient proof of safety and effectiveness is shown in peer-reviewed literature.

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