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search is in the forefront of developing new project management approaches in a high-risk industry. |
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1.
The Need for Policies on Prioritization. |
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To get some sense out of conflicting multiple clinical trials, some form of prioritization is necessary, and it helps to reduce this to as simple a level as possible. One company was accustomed to assigning individual priority levels to all of its clinical trials, so that there might be as many as 40 levels. The problem was that no one could remember the actual priority of each study, so, levels were not adhered to and were open to change without notice by senior management. Because so many other factors can influence the sequencing of trials, holding some up and releasing others, it is perfectly possible to manage them with as few as three priority levels (although some of the software systems confusingly allow many levels). |
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In recent years conferences on crisis management have been increasingly popular. Although much of the focus has been on drug safety crises, nevertheless, the great interest in the concept shows how much we tend to enjoy an emergencyteam spirit is always high, and there is a great sense of achievement at the end. But often the problem is not a genuinely unforeseeable one arising externally but simply a conflict of priorities. Figure 4 shows one clinical trial which is running late, and another trial is scheduled to start immediately after staff are available from completing the first. What usually happens is that the second project is delayed because of the need to finish the first, and this then feeds through the whole program until all of the projects are late and, thus, managed as crises. A better technique is to recognize the high priority of trial 1 at the outset and do everything possible to complete it on time, even if this means extra staff or other expense. Then, this breaks the vicious circle of crisis feeding crisis. An additional benefit is that, if projects are scheduled sequentially rather than in parallel, total investment is less and profitability is higher. This works in the following way. Figure 5 shows that, if two projects are conducted at once, there can be no return on investment until they are both completed. If one project is held up, and twice the effort put into the other, cash flow starts earlier, maximum investment is less (because the first helps to pay for the second), yet the second project is no later in completing. To put this into a clinical trial perspective, should you try to run two phase III anti-infectives programs at the same time? You might do better to put all your skilled people and budget on one of them, run twice as many study centers, and finish it |
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