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 necessarily authors of major professional papers on drug development, may be a useful source of information for physicians who were not participants in clinical studies.
Investigator-physicians are the first to work with drugs and thus have the greatest experience with them. Their behavior after the launch of drugs may well influence other physicians. Participation in phase 3 studies provides a mechanism by which investigators can gain access to new drugs under development nearly three years ahead of the general population of physicians.
By and large, clinical investigators are likely to be early adopters of new medications and hence may be more willing to participate in clinical trials. We have no way of measuring this general mindset regarding early drug adoption in this study. We do not have psychographic data on the investigators, and we have no information about how they prescribe other new drugs when they have not participated in these other clinical trials of new drugs. We do know from the data in this study, however, that investigators, more than other physicians in the study, do tend to adopt first-in-class drugs.
The investigators had earlier access to the study drugs, and they have seen new drugs being carefully tested in their own practices. Investigator-physicians who are new drug pre-scribers may be more numerous, simply because they are often comfortable prescribing drugs with which they have become familiar. Their involvement with clinical trials affords them this added experience with the drugs.
Whether or not investigators are more innovative in their general approach to medicine, or whether they simply tend to prescribe what they know, they are more likely to prescribe clinical study drugs when they have participated in the clinical development of those drugs.
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At all times during this study, and for nearly every comparison except for research-based or medical teaching-based physicians at three months after product launch, investigators were more likely than controls to prescribe the new drugs. For physicians in research or teaching institutions, their more restrictive outpatient formularies may be slower in admitting new drugs. Teaching hospitals often have a relatively higher percentage of patients whose pharmaceutical and medical care is compensated by government sources. These investigators may have initially been inhibited in prescribing new products because of the more restrictive formularies in their workplaces.
Eventually, however, the research-based and teaching-based investigators prescribed new drugs in a manner similar to that of other investigators, perhaps because their institutions began adding the new drugs to the formulary. Three months after product launch, the investigators’ prescriptions for the study drug accounted for a statistically significant higher USC share than did the controls’ prescriptions. This difference remained constant over the next 15 months.
Phase 3 investigators were more likely to prescribe new drugs for all indications studied, thereby making these drugs available to their patients sooner than control physicians did. Clinical investigators often have the longest and most extensive exposure to new drugs, and their patients may benefit from this experience during the clinical trial and after the product is introduced into the market. cialis soft tablets
Clinical studies are an essential step in the drug-development process. Investigators often play a central—and heretofore underappreciated—role in the way that new drug adoption is actually diffused into the general population of physicians. This might be especially true for first-in-class drugs.