Clinical Trails
Clinical Trials
A clinical trial is a research study designed to answer specific questions about new drugs, medical devices, or new ways of using known treatments. Clinical trials are used to determine whether the new drug or treatment is safe, and whether it works.
A clinical trial is a research study designed to answer specific questions about new drugs, medical devices, or new ways of using known treatments. Clinical trials are used to determine whether the new drug or treatment is safe, and whether it works.
Clinical trials consist of four phases:
Phase I tests a new treatment on a small group, and concentrates on safety;
Phase II deals with safety and efficacy, and expands the study to a larger group of people (several hundred);
Phase III expands the study to an even larger group of people (thousands), and is designed to determine conclusively whether or not the treatment is effective;
Phase IV takes place after the drug has been licensed, to monitor the drug for long-term effects.
What are the phases of a clinical trial?
The randomized, double-blind, placebo-controlled (or active-comparator-controlled) trial offers the strongest evidence that a treatment is effective. The number of participants also considerably effects how reliably the trial can determine the effects of a treatment.
Clinical trials must be consistent with good clinical practice (GCP), a rigorous set of guidelines designed to protect the participants’ safety and the integrity of the trial data. The FDA requires pharmaceutical companies and contract research organizations to conduct rigorous clinical trials verifying the safety and efficacy of the new drugs before granting approval for marketing.
The trial objectives and design are usually documented in clinical trial protocols. Once the objectives are determined, case report forms must be carefully designed to gather complete, unambiguous data from the trial.
During the trial, the data management team must continually monitor and verify the data to ensure that they are accurate and consistent. Any missing or inconsistent data must be investigated and corrected.
The randomized, double-blind, placebo-controlled (or active-comparator-controlled) trial offers the strongest evidence that a treatment is effective. The number of participants also considerably effects how reliably the trial can determine the effects of a treatment.
Clinical trials must be consistent with good clinical practice (GCP), a rigorous set of guidelines designed to protect the participants’ safety and the integrity of the trial data. The FDA requires pharmaceutical companies and contract research organizations to conduct rigorous clinical trials verifying the safety and efficacy of the new drugs before granting approval for marketing.
The trial objectives and design are usually documented in clinical trial protocols. Once the objectives are determined, case report forms must be carefully designed to gather complete, unambiguous data from the trial.
During the trial, the data management team must continually monitor and verify the data to ensure that they are accurate and consistent. Any missing or inconsistent data must be investigated and corrected.
Base SAS Certification Exam Model Questions:
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Base SAS 9 Base SAS 10 Base SAS 11 Base SAS 12 Base SAS 13 Base SAS 14 Base SAS 15
Base SAS 16 Base SAS 17 Base SAS 18 Base SAS 19 Base SAS 20 Base SAS 21 Base SAS 22
Base SAS 23 Base SAS 24 Base SAS 25 Base SAS 27 Base SAS 28 Base SAS 29 Base SAS 30
Base SAS 31 Base SAS 32 Base SAS 33 Base SAS 34 Base SAS 35 Base SAS 36 Base SAS 37
Base SAS 38 Base SAS 39 Base SAS 40 Base SAS 41 Base SAS 42 Base SAS 43 Base SAS 44
Base SAS 45 Base SAS 46 Base SAS 47 Base SAS 48 Base SAS 49 Base SAS 50 Base SAS 51
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Base SAS 113 Base SAS 114 Base SAS 115 Base SAS 116 Base SAS 117 Base SAS 26
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