PRACTICAL CONSIDERATIONS

While beyond the scope of this chapter, the following practical issues are worthy of careful study before proceeding with drug development:

• Study planning and budgeting: Carefully constructing and administering the study budget (which may be in tens of millions for a Phase III trial), deciding on optimal methods of data collection in multi-center trials (e.g. the use of web-based data forms, standardizing instructions for the administration of subjective evaluation instruments); coordinating the timely availability of all study supplies (e.g. study drug, properly translated patient diary cards, case report forms).
• Study initiation: Selecting investigators and study sites that can reliably recruit a sufficient number of patients and deliver high quality data; employing techniques to speedily obtain institutional review board and regulatory approval of the protocol; putting in place various methods to enhance the rate of patient recruitment (often the major determinant of the time to trial completion); motivating study personnel to work well and hard.
• Study conduct: Efficiently monitoring the performance of individual sites and the trial as a whole; timely identification of sites and investigators with quality and productivity problems; optimizing way in which data are brought from the study sites to the central location where QA and data entry are done.
• Post-study activities: Streamlining data analysis and interpretation; coordinating the production of data summaries, manuscripts, and the final study report.

Optimally managing these and a multitude of other activities requires extensive experience in actually running clinical trials. A company serious about clinical development should have such practical expertise available in-house and/or acquire it by working with knowledgeable consultants and CROs.