Prior to selecting a clinical trial to participate in, the PRC doctors complete and in depth review of the study medication, study medication options and the similarity of standard treatment to the study design to select the clinical trials that offer the least risk and most benefit to the volunteer.
Prior to the study medication being tested in humans it has to successfully complete years’ oflaboratory testing (pre-clinical testing). The sponsor must then review all the data and consult with the FDAfor advice on continuance and direction of the clinical trial program.
At each phase of research the clinical trials are intended to reveal the overall safety and the effectiveness of the drug for the indicated purpose while keeping the FDA apprised of the clinical trialoutcomes. As the clinical trial program moves forward, the targeted effective dose of the drug is narrowed down, the clinical evaluations proceed to be able to submit a new drug application to the FDA fortheir review and approval, denial or request for additional trials.