ePRO Solutions: Should we eliminate paper altogether in clinical trials?

??????????????????????????????????????????According to a study by CenterWatch, if the market continues to adopt ePRO technologies, paper diaries will no longer exist in 10 years. In an increasingly interconnected world, where technology can make data available in real time and increase the quality of collected data, why are we still using paper diaries to collect subject data in clinical trials? 

ARITHMOS looks at potential scenarios in clinical trials using paper vs electronic diaries and provides an example of a respiratory study in which an ePRO solution determined the success or failure of the study outcome. 

 

Quality of Data: Collecting Accurate Data in Real Time

In a paper diary scenario, clinical trial leaders face many challenges including illegible forms and uncompleted questionnaires. This wastes a Data Manager’s time trying to decipher a subject’s diary entries and ask for missing information.  More importantly, paper doesn’t always guarantee an accurate and honest response. The British Medical Journal reports in a pain study example, 45 percent of subjects invented data because they waited until the deadline to fill out questionnaires and had to recall weeks of data.

ePRO takes the burden off the subject and allows clinical trial leaders to have more control over the situation. Devices can be programmed to send reminders to subjects so they fill out diaries with real time data and submit data in real time.

Compliance

Technology has allowed ePRO devices to come in all shapes and sizes – from smartphones to tablets that integrate with Glucometers to spirometric devices that capture respiratory data. These devices have been proven to increase compliance among adults and elderly subjects who can adjust viewing screens and respond to questionnaires with a simple click.

Moreover, studies have demonstrated that subjects have a greater sense of privacy with ePRO devices. Subjects might be hesitant to respond honestly on a paper form knowing that various people will read their answers. In a study on female sexual dysfunction, subjects reported 80 percent more sexual episodes on an eDiary as opposed to a paper diary (cit. CenterWatch).

Reducing Study Timelines, and Inevitably Costs

ePRO solutions can be significantly advantageous for biostatisticians, especially when applying an adaptive approach to a study. Based on accurate and high quality data and data available in real time, biostatisticians can adjust sample size calculations and study endpoints which can potentially save money.

Paper diaries may be a viable option when time is not an issue, however is a time when pharmaceutical and biotechnology companies are struggling to cut trial timelines and costs, this hardly seems a feasible option.

ePROARITHMOS can provide a customized ePRO solution for its customers or work with third party ePRO devices and integrate with the eCRF. Below is an example of an ePRO solution ARITHMOS implemented in a respiratory study which used a hybrid solution:

A CRO contracted ePRO and EDC services for a respiratory study combining eCRF with paper diaries and paper questionnaires. The device was a spirometer with an integrated QoL questionnaire. The study also required a short deadline with external providers for IVRS, laboratory data and ECG and direct upload of spirometry data onto eCRF. Milestones included:

  •  eCRF receiveddata from 2,000 subjects in 14 countries from 207 sites
  • It was easy to identify subjects who experienced problems in using the ePRO and perform the appropriate corrective actions
  • The team was able to have the last query resolved to database lock in 2 days using innovative technology solutions to integrate a spirometric device with EDC
  • Each subject was given a Spirometric device for 1 year, collecting 700 records each. Over 14,000 total records were collected with almost 100% success. Any mishaps were handled immediately due to an alert system.
  • Blind Review Meeting was done 2 days after study completion since all data was immediately available. Without the spirometric device, it would have taken up to 3 months.
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