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that are known to be stable, where no one ventures to other disciplines and new people are rarely hired, might rest somewhere between sedentary and moribund. While people need to develop in the core competencies and in team-based behaviors, there will always be the need to develop new skills. |
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Two of many areas to consider for cross-training or hybridizing are pharmacokinetics and biostatistics and also clinical monitors (CRSs) and data managers. For example, in the past pharmacokineticists and biostatisticians have collaborated on issues such as decisions in bioequivalence testing. Both groups are currently engaged in analyzing pharmacodynamic information, but in remarkably different ways. Pharmacokineticists tend to look at single-dose PK/PD or Phase II/III population models. Biostatisticians tend to focus more on hypothesis testing for large efficacy trials. If a hybrid clinical statisticokineticist was developed, companies might become more creative in developing more efficient and relevant designs and analyses for Phase II and III trials. The idea of creating disease models and searching for drug effect over time should be natural area of mutual scientific interest. |
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In collecting the information from clinical pharmacology studies, the clinical monitor tends to throw the case report forms over the wall to the data manager. From that point forward the ownership of the data, the cleanup, and database entry process gets murky, often resulting in long delays in reporting the final data and submitting the final report. Data quality, access, and speed for decisions and reports could be catalyzed both by cross-training in disciplines and expanding the career path. This new hybrid clinical study and data flow person might speed data-collection format from paper to computer and maintain continuous responsibility for data integrity and access. |
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The science disciplines that are the foundation of clinical pharmacology in the drug development environment are pharmacodynamics, pharmacokinetics, and biopharmaceutics. These skills are blended with medical specialties and aspects of biostatistics. The clinical experience gained in experimenting on healthy people and patients is a unique aspect within the pharmaceutical company, particularly when a drug-study unit is part of the function. The decision process to administer a new chemical to a human for the first time is pharmaceutical medicine. Long-term practitioners develop an unwritten wisdom that their colleagues depend upon. They assess the safety of new chemicals that might as easily be a poison as a life-saving drug. While most drugs have been discovered and developed by drug companies, the new science that underpins clinical pharmacology has been developed by academic centers. Industrial clinical pharmacologists apply the science to sorting out useful drugs from poisons and place-bos and then recommending how they should be dosed. Investing in academic |
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