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!