Tbd

Early - P. 1/2

Fig. 3.15. Biotechnology Product Pipeline* *Amgen, 2004; Public Information r U.S. 52,000 with at least one trial r Education & Training o Degrees: MD 96%, DO 3%, Other 1% c Certification: IM 50%, N/Psy 9%, Ped 8%, FP 5% o Age: 45-50 yrs, 45%; 51-60 yrs, 32% Trial experience: < 1yr 63%, 2-4 12%, > 5 25% r Rationale for involvement c Scientific reward p Financial reward c Better patient care r Setting: Group practice vs University

Fig. 3.16. Clinical Investigators (A Profile)

applications to regulatory authorities and with reasonable alacrity. However, new products in research may pose educational challenges for all investigators, even experts, related to new mechanisms and new protocols. Training of investigators is a major undertaking for pharmaceutical companies, related to each and every specific protocol for a product, especially related to patient recruitment and eligibility, product administration, monitoring and case report forms, all of which are very specifically spelled out in study protocols. Figure 3.16 documents that the industry used about 52,000 investigators in the USA alone, which can be characterized as mostly M.D. physicians with relatively limited research experience (63% less than 1 year), older practitioners by age and time in practice, and practicing in both clinical settings of the university or clinical office practice. The university expert usually leads the study effort for the company, but often many practitioners are needed to recruit sufficient patients that qualify for a study. University-based patients are often tertiary care, complex patients that may be too sick or have too many complications to participate. Also, the practitioners have access to many more patients in number. The rationale for a clinician to participate in a trial includes three major motivations; first, the science, engagement in novel products to advance science; second, financial reward from the compensation for participating in a trial (research grants), especially for the university where grants are a major part of advancement criteria; and third, an opportunity to help create better patient care through improved therapeutic products [5].

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Project Management Made Easy

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