Clinical Trials

Phase II can be subdivided into

IIa - assesses optimal dosing & adverse effects

IIb - assesses efficacy

Mnemonic: does the drug "SWIM"

Phase 1 - Is it Safe?

Phase 2 - Does it Work? i.e efficacy

Phase 3 - Is Improved? compared to standard care

Phase 4 - Market Survival

Post-marketing surveillance is the monitoring of the safety of medications or devices after they have been released on the market. The true safety profile of any medications is really understood only after the medication has been on the market for a period of time and has been used by a large number of patients.

Scenario:

An HMO has its annual medical directors, meeting, and new treatments are discussed. A recent study has just clearly demonstrated that a new drug can lower blood pressure significantly, although monitoring tests for renal function are required. The directors consider adding the treatment to their list of approved treatments but feel handicapped. Which of the following is one of the real disadvantages of making treatment decisions based on clinical outcomes alone?

Ans?

Although clinical trials can determine which treatment works best, they cannot determine the cost of this success. Unfortunately, they do not take into account costs and ultimate benefits, which would be the role of a costbenefit study. If properly constructed, with study and control groups randomly drawn from the general population, the results should be applicable to the general population. In addition, they usually determine what works best by measurement of a clinical endpoint. In many cases, the treatment may achieve its objective, but the change in parameters may not be significant. It is worthy of note that the USPSTF is now taking cost-effectiveness into account when making recommendations. Clinical trials ignore the difference in costs between treatments.

Survival Analysis