Technology in Registries and Observational Studies - What You Should be Considering (Part II)

Technology in Registries and Observational Studies - What You Should be Considering (Part II)

The increased use and importance of observational studies necessitates sponsor evaluation of standard operating procedures for clinical trials. Often the focus of that evaluation is on methodology, structure, and resulting evidence, but it is just as critical that the technology details be evaluated as well. As touched on in our first post, many facets should be considered during development of platforms for registries and observational programs. Components already covered include: audience, burden, data cleaning and notifications/compliance. Now, let’s continue the list:

Developing a customizable, action-driven dashboard allows a call center to manage program workload. Via a dashboard, managers have the ability to monitor performance based on task completion and compliance rates, and workloads can be easily modified to fit targeted goals and service level agreements.

Size / Length
Unlike clinical trials that are specific in size and length, most registries and observational programs have a very large patient population and can have an extensive follow-up period. Due to the amount of data collected, it would be wise to:

  • Have a defined upgrade path that will allow the technology to execute and stay current for more than 10 years

  • Test and prove the platform with sizable amounts of data to ensure there is no performance degradation as more data is being collected

  • Incorporate the ability to adjust to dynamic program process improvements and modified follow-up algorithms. Being able to identify locked forms at any time and having the ability to extract the interim locked data for analysis is a must for such programs, since the analysis cannot wait until the end of the study.

Customization / Flexibility
The platform needs to have the flexibility of customizing any behavior and workflow in order to quickly respond to change requests. The data collection forms need to be extremely flexible and  easily modified. Because data fields will be updated after the release of the program, the platform will also need to intelligently define the impact on the current data or data collection form based on a given change, eliminating potential data loss as a result of the changes.

Reports that compare site data to aggregated national data, and that graph events over time to show improvement versus degradation of patients, are integral tools in the analysis and interpretation of study results.

The lists provided in both posts are good starting points for the evaluation process necessary to tailor registries and observational studies to your specific needs. However, we suggest that information technology experts be included in the early stages of decision making and design to ensure the right data is collected in the right ways from the right people with the least amount of burden or potential for error. If you find more guidance is needed, we are available to assist. Please contact us.