Clinical investigators are integral to the drug-development process. They often play an important additional role in the adoption of new drugs, particularly for first-in-class agents. In the U.S., most investigators are practicing physicians in office or hospital settings, with only a portion of them based in medical schools and teaching hospitals. These practicing investigators, although not [...]

In the three months prior to the drug’s launch, both investigator and control physicians wrote a mean of 2.2% of all their prescriptions from the pharmaceutical company launching the new drug (SD ± 6.0 for the investigators, SD 4.3 for the control physicians). During this time, investigators wrote a mean total of 677 prescriptions (SD [...]

The drugs, or compounds, in clinical trials are classified by an indication based on the International Classification of Diseases, Ninth Revision (ICD-9) coding system. All of the drugs that we examined in our study represented new molecular entities (NMEs), or substantial reformulations of an existing drug. We required the re-formulations (e.g., extended-release) to be complete, [...]

Study Sample
To answer the study question, we randomly selected 2,187 physicians who were involved with at least one phase 3 clinical study as principal investigators at 2,897 clinical sites from January 1, 1995, to December 31, 1996. (Some physicians conducted studies for more than one indication.) For physician selection, we used a database that tracked [...]

Phase 3 clinical trials are critical to new drug development because they help to secure regulatory approval for the new drugs and add to the general medical knowledge base. The published results from these clinical trials are important in the adoption of new drugs; key results relating to a new drug’s safety and efficacy appear [...]