|
|
|
|
|
|
|
on Harmonisation should ultimately mean that data for marketing authorizations will be in common formats worldwide and to common standards (although admittedly this goal is some way in the future). Medical communities which continue to adhere to a cottage industry mentality in clinical research may find themselves sidelined in favor of the better organized. |
|
|
|
|
|
|
|
|
7.
A Vision of the Future |
|
|
|
|
|
|
|
|
Therefore, these well-organized centers will be taking on all the systems and methods familiar to the pharmaceutical companies: GCP, quality systems, and, of course, project management. The opportunity for the business community is there for the takingto transfer these skills to the medical community while there is still time. One of the great strengths both of GCP and project management is the concept of accountability. GCP clearly states the obligations of the parties involved, and project management enables compliance by building the obligations into plans which can be carried out effectively. The major risks which we discussed earlier, among which clinical data volume and quality failures are very prominent, must be addressed by clinical centers. |
|
|
|
|
|
|
|
|
It is not acceptable for principal investigators to sign protocols without reading them and to delegate all the work to junior staff who lack the proper training and time to meet the study's targets (and still to collect the fees). This may sound excessively negative, but it is commonplace in many active clinical research centers. |
|
|
|
|
|
|
|
|
Formal quality systems are surely set to become more integrated into project plans, rather than a kind of afterthought (oh yes, we must schedule a site audit some time). This will take the form that deliverables become more accurately specified in plans, so that it is clearer when they have been achievedand this will happen at all levels from the data source to the sponsor's top management. The clinical project manager must add to the classical triad for each tasktechnical objective, cost, and time deliveredthe quality standard specified and how it will be proven. |
|
|
|
|
|
|
|
|
More automation at study sites will enable far better estimates and, thus, more realistic plans, because valid data will be available. Health service data will become properly organized to enable data mining for feasibility studies, lessening the chances of embarking on unsound clinical trials. |
|
|
|
|
|
|
|
|
With globalization rapidly overtaking drug development [9], all of these new tools will need to be adapted for use across different cultures. In practice, it will almost certainly not be possible to harmonize at the clinical site level to any useful extent, because medical practice is organized so differently around the world. Therefore, project management must pay even more |
|
|
|
|
|