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clinical research people (who did not respond). The clear message was that most chief executives are not worrying at all about meeting clinical research objectives and see it as their subordinates' problem. This could be understood if it applied to drug discovery or preclinical research, but clinical trials are consuming resources and timescales at an escalating rate. If the really worrying issues get such scant attention, is it surprising that project managers lack support? It may well be argued that managers should be empowering staff by delegation, but there is a big difference between offloading responsibility wholesale and delegating key decisions which are backed up by the authority to get them enacted. |
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G.
How to Create Empowerment |
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Even if one's own scenario seems so disappointing, there is hope! If many of the causes of project failure are related to poor communications, the project manager can achieve much by ensuring that what has been agreed to is widely known within the organization, especially in the upper strata. When a clinical plan or protocol has been agreed upon, why not send a summary to top management, itemizing the key deliverables, who is responsible, and when they have been promised. Even if top management does nothing, is it more or less likely that drug supply (for example) will be on time and correctly packaged, when pharmacy department knows who is aware of the agreement? Eventually, of course, top management starts to take some notice of these succinct summaries from clinical research, especially when they are followed by positive progress reports. |
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H.
Clinical Research in the New Global Village |
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As long as pharmaceuticals continue to be produced, clinical trials will be necessary. Among the many questions are Who can afford to do them, where will they be done, and how will possible changes in practice affect their management? |
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Many factors are influencing the world of clinical research, and we will speculate on just two. The first is impossible to ignore, and that is the headlong development of information technology, which impacts on most areas of business and daily life. To begin at the beginning, there is enormous scope for improving the planning stages of clinical trials, especially in collecting information to produce estimates of timescale, cost, and labor. Looking first at cost, an initiative is already in place with the PICAS database [6]. This attempts to compare investigational site costs. The data source is costs from actual studies carried out by subscribing companies. |
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