Does One Clinical System Fit All Studies?

by Haibin Shu

Does One Clinical System Fit All Studies?

by Haibin Shu

by Haibin Shu

The answer is ‘No’ because it’s very hard to build or find a system that can fit into the needs of all clinical trials. Therefore selecting the most sufficient-effective system would become very important prior to launching the upcoming clinical trials.

In theory one would think it might be possible to include all factors when creating such a system, in reality however, the efforts might be too much to be justified. Let alone the ever evolving status of clinical trial requirements – e.g. the best paper-based system in history would fail to address the basic needs of a simple study nowadays that requires electronic data capture.

Some factors to consider when selecting a clinical system:

  • Experiences of site users: less experienced users may require much more robust and less error prone systems to work with for data entries and other necessary tasks.
  • Study design including visit structures, key data points etc.: the more complex a study is the more programming requirements it might need to implement such as edit checks, metric reports etc. So it may require a system that provides strong programming capabilities in the backend.
  • SAS extracts: many systems are equipped with on-demand-type data extracts which make it very convenient to extract real-time data for necessary reporting and analyses. Contrarily for systems that don’t provide such capability it might become a daunting task to get SAS data sets out of the system and nothing could be done until SAS data sets can be generated.
  • Balance of front-end and back-end: a system can easily be voted down if the front end functions aren’t as desirable; on the other hand attentions should be paid to the back end functions as well. Selecting a system with friendly front pages but insufficient back end functions equals driving a nice looking car without a good engine!

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