One of the challenges of clinical research is to collect quality data in a timely manner. This means that, in order for data collected during clinical trials to be solid enough to support a regulatory submission and, if warranted, a market authorization, sponsors must be certain of its reliability. For a very long time certain elements of clinical data have been gathered directly from patients in the form of questionnaires. In order to provide information on the clinical benefits or reactions to a study drug, trial participants would complete these paper questionnaires on their own, often times while at home, and would return these questionnaires to their study investigator. Such questionnaires could be for example patient diaries to track potential Adverse Effects (AEs), self-administration dairies to track compliance, quality of life questionnaires or questionnaires to follow-up on a specific marker linked to the drug’s effect. In some cases these questionnaires related to quality of life could be a decision maker for the market authorization filing for example in the case of oncology or rare disease drugs. These elements fall under the generis term of Patient Reported Outcomes, or PRO. This system, while offering the advantage of potentially gathering a comprehensive dataset also has several disadvantages including:

 

  • Possible lack of data reliability, as subjects may enter data at a later moment than required, e.g. just before a visit to the study site, rather than in an ongoing manner throughout the trial. In this case the data will lack reliability as it will not have been captured in real time as initially was intended

 

 

  • Requiring a potentially large effort from study site staff and trial monitors to ensure that data from the questionnaires is correctly entered into the study database (DB) at the site. This effort may in some instances require a large amount of work which could be spent on other, more value-adding tasks, such as site training or patient oversight

 

The decision made by Clincase to develop an electronic system to capture PRO, called ePRO, was based on these observations with the goal of:

 

  • Increasing data reliability as we can know when data has been captured and thus that it is done at the moment closest to an event

 

  • Reduce the need to perform data entry and monitoring at the study site, freeing up precious staff time to dedicate to higher-value activities

 

  • Provide real time, on-line access to the PRO data to all the people in charge of the project

 

To find out more about clincase ePRO please send us an email info@clincase.com

 

 

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