Question

In: Nursing

Match the following definitions with the type of clinical trial:(a) preclinical, (b) phase I, (c)...

Match the following definitions with the type of clinical trial: (a) preclinical, (b) phase I, (c) phase II, (d) phase III, or (e) phase IV. ____ Studies involving animals or cell cultures. ____ Conducted to determine the safety of a treatment in humans. Patients go through intense monitoring. ____ Large studies (may or may not be a randomized trial) conducted after the therapy has been approved by the FDA to assess the rate of serious side effects and explore further therapeutic uses. ____ Relatively large randomized blinded trials used to ____ Relatively large randomized blinded trials used to evaluate the efficacy of an intervention. ____ Investigator explores test tolerability, safe dosage, side effects, and how the body copes with the drug.

Solutions

Expert Solution

A- preclinical -Studies involving animals or cell cultures.

B-phase 1 - Investigator explores test tolerability, safe dosage, side effects, and how the body copes with the drug.

C- phase 2 -Conducted to determine the safety of a treatment in humans. Patients go through intense monitoring.

D- phase 3- Relatively large randomized blinded trials used to evaluate the efficacy of an intervention

E - phase 4-Large studies (may or may not be a randomized trial) conducted after the therapy has been approved by the FDA to assess the rate of serious side effects and explore further therapeutic uses.


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