Understanding of the drug development process

All new clinical staff need to understand the overall drug development process. Before new investigational products can be introduced into man, extensive preclinical and toxicological studies are performed. Staff who will be responsible for the clinical portion of drug development need to have an appreciation of the work that has been undertaken to progress the compound through to the clinical phases.

This includes understanding the vision, mission and objectives of the sponsor's clinical development strategy. Most sponsors have a unique inves-tigational product development system. Being familiar with this system is important in understanding the sponsor's decision-making approach, its internal milestones, and its methods for budgeting and resourcing clinical programs. Individuals new to industry should identify and understand the function of the major departments comprising the clinical research and development process, as well as understanding the operation of sponsor management bodies.

To gain this knowledge, new staff members should attend the sponsor's orientation program on drug development and the appropriate Pharmaceutical Education and Research Institute Inc. (PERI) or Drug Information Association (DIA) overview courses on investigational drug development. There is considerable literature available that discusses the drug development process, such as the Guide to Clinical Trials by Dr Bert Spilker. Regulatory authorities provide important guidelines on registration expectations. In addition, many sponsors have internal documentation explaining the company's systems and processes. Senior-level staff can also attend the advanced course on international investigational product de velopment and regulatory issues sponsored by Tufts University.

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