E. Integrating GCP, Quality Systems, and Project Management
222
F. Getting Things DoneThe Clinical Project Manager's Authority
223
G. How to Create Empowerment
224
H. Clinical Research in the New Global Village
224
References
231
The clinical phases of drug development present some of the most serious tests of management skills. The selected drug candidate demands rapidly escalating resources, in labor and cost, and, at the same time, much of the influence on progress is passed to third partiesthe clinical investigators. The purpose of this chapter is to examine the special challenges encountered by the clinical project manager and to consider the skills and methods needed to bring successful medical products to market on time. It should be emphasized that these skills apply to all levels of clinical project management from the clinical development plan down to the individual trial and to project management at the strategic level.
I.
Are Clinical Research Projects Really Different?
A.
RealismClinical Research's Holy Grail
There is a widespread management technique which imposes impossible goals with no expectation that they will be achieved. What the proponents of this method do expect is that another goal, secret and less demanding, will be achieved; the logic is that people will respond to unreasonable pressure by working harder than they would do if the target were realistic. You will not find this idea in any serious book about management because it does not work. People are demoralized by a continual sense of failure and do not respect unattainable objectives. Yet the author has worked for companies which practiced this and has many consultancy clients who are its victims.
This point is made to emphasize that the fundamentals of good project management are dealing openly with people on a realistic basis. In clinical trials, there are special reasons for adhering to these principles. Figure 1 gives some idea of the different people and disciplines with which the clinical research specialist has to interact. This illustration is not intended to show reporting lines or authority; the connections show the negotiations
