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attention to forging multilevel links between strategy and operations. National subprojects can tailor their management to local needs, and planning and progress control will consolidate project data at an appropriate level of detail. One useful approach in such a scenario is for the manager to plan only deliverables and to let project teams worry about how they will meet their objectives. Thus, the project plan becomes a list of deliverables (what do we have to produce?), not a list of tasks (what are we going to do?). Curiously, some project software pays scant attention to deliverables. The author recently evaluated a new software system which did not have the term in its database, and the help desk staff had never heard of it! The simple solution is to use the task field to enter the deliverableit is really a matter of terminology, but the intellectual difference is important. |
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This focus on deliverables is a fitting note on which to conclude. So much effort can be wasted in pharmaceutical development by worrying about what we have to do, rather than what we should be handing over to the next stage. If this relatively simple attitude change could be achieved across all the disciplines in clinical research, the industry would have a much more secure future. Technology is now becoming available to communicate such a change to everyone involved, so there will be no excuse for not doing it. It will be much easier to achieve the clarity of purpose which is vital for survival into the next millennium, if the following key concepts can be incorporated into the drug development program: |
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planning based on real data rather than guesswork and optimism, |
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active participation in planning by multidisciplinary teams, |
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empowerment of clinical project managers by top management, which will need clearer definitions of responsibility and authority, and |
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bringing clinical study sites closer to the inner project team. |
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The author gratefully acknowledges the contribution of Tony Berridge, Director of Technical Management Development Ltd, and Non-Executive Director of Medical Scientific Services Ltd, for reading the manuscript, for helpful comments, and for permission to use material for some of the illustrations. |
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1. Department of Health. Local Research Ethics Committees. HMSO Dd DH 003009 7/92 C20 G3392 38776. |
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