If not randomized, biases can make determination of causation difficult will be used for
patients on whom it has not been studied or for whom it is cost-ineffective. In these …

The availability of drugs and medical devices has unquestionably benefitted many patients
and fundamentally changed the way healthcare is delivered. However, drug development is …

THE CENTRAL THEME OF THE INSTITUTE OF MEDICINE report on the US drug safety
system was the need for a life cycle approach to drug evaluation: both the benefits and the …

Postmarketing evaluation The reporting systems for adverse drug reactions in most
countries are voluntary and depend on individuals becoming suspicious that an event is …

Background: Nonrandomized safety and effectiveness studies are often initiated
immediately after the approval of a new medication, but patients prescribed the new …

A new drug is approved for use if its efficacy and safety have been demonstrated. However,
healthcare decision makers may also require data on the cost-effectiveness of new drugs if …

The vastness of clinical data and the progressing specialization of medical knowledge may
lead to misinterpretation of medication efficacy. To show a realistic perspective on drug …

The development of a new drug is often portrayed as a series of increasingly demanding
clinical trials, performed in patients with a single target condition, as the development …

In the process of deciding whether to fund a clinical trial, the sponsor weighs the investment
of dollars, effort, and time against the information the trial is likely to generate. Varying …

Background: Facing financial pressures, the provinces and territories have chosen to use
“costeffectiveness” for making decisions about drug listings. This study examines the …