BY DANISH.IBRAHIM.JASNAIKBBI-11006

Submitted to: Lijin Sir

CLINICAL TRIAL PHASES

Clinical trials

Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy (In medicine, efficacy indicates the capacity for therapeutic effect of a given intervention data for health interventions e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought.

• Randomized control trials on large patient groups (1000-3000)

• Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies.

• Studies move into this phase only after a diagnostic agent, modality, or treatments have shown promise in phase I and II trials

• Many phase III trials are randomized and blinded.

PHASE III

Randomization Study?Randomization means Researchers assign patients by chance to either a group taking the new diagnostic or treatment agent. Similar to “flipping a coin”.

Example: Patient #1 is assigned to Arm A of the trial, which involves the new treatment. Patient #2 is assigned to Arm B, which is the standard treatment.

Blinded Study?

Blinded study means, the patient does not know which arm of the protocol they have been assigned to.

Example: Patients who know that they are assigned to the “new treatment” group might expect it to work better and report hopeful signs because they want to believe they are getting well. This could bias the study by making results look better than they are.

• Pre-approval, post-launch

• Involve safety surveillance and ongoing technical support of a drug.

• Sometimes mandated by the FDA for additional testing including interactions with other drugs and testing on certain populations.

Phase IV

• Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study

• Adverse effects detected by Phase IV trials may result in withdrawal or restriction of a drug -

Examples include Vioxx (used in the treatment of arthritis and other conditions causing chronic or acute pain. On September 30, 2004, Merck withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use.

Phase V is a growing term in the literature of research to refer to community-based research, it is used to signify the integration of a new clinical treatment into widespread public health practice.

PHASE V