Can Technology Streamline Clinical Study Design?

posted on April 3rd 2014 in Recommendations with 0 Comments /


We frequently hear from our clients that their clinical study design processes are cumbersome and take a long time to complete. Additionally, down the road, our clients are frustrated with the challenges that “pop up” as the clinical trial is on-going and they are collecting and monitoring the data.

Our recommendation begins with implementing an EDC system. Our EDC technology platform of choice is Medidata Rave®. Rave’s flexible design supports any organization’s clinical processes and unique clinical trial design needs. Rave has a great study build module known as Architect.

Using a clinical study design module such as Architect has three primary benefits:

  1. Decreasing the time it takes to build a new study
  2. Increasing efficiency in clinical data collection processes
  3. Enhancing the quality of the collected data

Once a client adopts Rave we work with them to design their study using Architect, while keeping in mind the following best practices…

Know when to use duplicate forms rather than dynamic data entry

Duplicate forms functionality is best suited when there are 2-3 discrete differences in data collected at different time points. An example is with vital signs screening. Frequently sponsors collect a more extensive set of vital sign data at the initial visit than at subsequent visits. We recommend our clients use a Vital Signs Screening form for the first visit and a Vital Signs form for subsequent visits. Additional uses for the duplicate forms functionality is in collecting pharmacokinetics, pharmacodynamics, and serial ECG data. The benefit of using duplicate forms is that sponsors can report measures based on defined time points throughout the study.

Take advantage of skip logic to increase clinical trial efficiency

Using skip logic functionality allows certain elements (or fields) to be dynamically enabled (or skipped) based upon the values that are previously entered. So, only the required fields that study sites need to enter are displayed. This reduces the likelihood of errors. Additionally, since only the required data is requested, the amount of time needed for data entry at the study sites is decreased. This also decreases the amount of time data management teams spend cleaning and monitoring the data, which leads to decreased study expenses.

Using defaulted data to comply with data standards (CDASH/SDTM)

Defaulting data is a feature in Rave that lets the sponsor pre-populate text in fields. This feature is especially helpful in populating timepoints. This takes the burden off the site to enter data that is helpful with standardization. This feature can also be used to design studies that comply more with standards. Duplicate forms, skip logic, and defaulting data are best used together to reap the benefits of efficient and user friendly data collection.

Use repeating forms (instead of log forms) when a lot of data is being entered

Repeating forms are  especially helpful when multiple records are expected or when large volumes of data are collected for each record. Repeating forms make it much easier to enter data and navigate through the eCRF to review collected data as all information is displayed on the equivalent to one screen width. In Medidata Rave data managers and clinical research associates can run reports that indicate the eCRFs that are overdue for data entry by site and study subject.

Using a clinical study design tool such as Medidata Rave’s Architect module, can decrease study build time, make clinical trial data collection more efficient by using standards, and enhance the quality of the data that is collected. At eClinical Solutions our team has helped many life sciences companies realize these benefits, and we can help you too.

If you are interested in learning more about the use of Medidata Rave to speed up your clinical trial design processes, please stop by and see us at the upcoming Mediata Symposium 2014–Americas in San Francisco April 23 – 25, 2014. We’d love to learn about your needs, and discuss how we can support your clinical trial data management needs with innovative IT products and platforms.

Join the conversation! Has a clinical study design tool improved the data collation process for your organization?

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