Nurse Practitioners as Principle Investigators in Pharmaceutical Clinical Studies
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The pharmaceutical industry spends over $14 billion each year in research and development (R&D). A large portion of this R&D is spent in clinical trials testing the safety and efficacy of new drugs. These clinical trials are conducted at universities and private hospitals, clinics, and by specialized companies known as site management organizations (SMOs). Nurse practitioners have the opportunity to take advantage of this huge industry in the role of primary investigator or sub investigator, conducting studies in their office or clinic. Being part of pharmaceutical research is looked upon as being beneficial and desirable, offering additional care, specialized testing and access to state-of-the-art medicine. The Nurse Practitioner as an investigator can also benefit from pharmaceutical studies by increasing professional networking and income potential. Organization is the key to a successful clinical study. Getting ready and organizing a study takes intense planning. Studies need to be set up, space made available, supplies obtained, and coordinators hired. Budgeting is another important part of study planning. To continue to do studies in most settings, they need to be profitable. Finally, subjects need to be recruited. Subjects can either come from an investigator's practice or advertising. Both groups have been found to be equally valuable, but advertised subjects will add an extra cost to the study budget. Documentation is critical. Inaccurate or incomplete source documentation can make monitoring visits by the sponsoring company difficult or even cause a sponsor to not reimburse for a subject due to inability to show appropriate enrollment and proper study procedures. Pharmaceutical studies can be beneficial to both Nurse Practitioners as investigators and to their patients. Good organization is the key, along with the knowledge of how to get started, to a successful, profitable pharmaceutical clinical study.