ePRO/eCOA in clinical trials: 3 keys to save a lot of time.
The acronyms ePRO and eCOA define the tools used to collect data directly from the participants in clinical trials.
In such trials it is necessary to collect data directly from the participants. Historically printed forms or questionnaires have been used to this end. The participants would fill these forms by hand at different stages of the trial and later on this data would be manually transferred to a database.
This data collection method entails several issues and headaches:
- Paper questionnaires must be collected and then transcribed or transfered from paper to digital. In order to minimize errors during the data copy this process must be done in duplicate.
- Problems with the collected data: errors, difficulties with understanding handwriting…etc.
- Once the collected data is in a digital format it must be united with each patient’s clinical data so that all data can be accounted for in the statistical analysis of the trial.
- Impossibility of collecting the data in a non-presential and remote manner.
- The need to store and keep paper forms safe for years or to scan them to keep a digital copy in case physical storage is not desired.
The ability to digitally perform this collection in a direct manner, facilitates and speeds up the clinical trial, although 3 keys must be considered to prevent this method from becoming an issue.
Key 1: Easy for the participants
This is fundamental. Some study participants could have a very basic technological level, and that is why the offered system must be as easy to use as possible.
A complicated system for the study participants, will result in very few participants being involved and filling the required data.
So important factors to accomplish such simplicity and ease for the study participants are, among others:
- Intuitive and easy to use
- It avoids the display of meaningless questions based on previous answers. (Skip logic)
(Gif animado de un formulario ePRO rellenándose)
Key 2: It allows remote access
An important matter to consider is if the collected information can be sent remotely by the participants. That way we can avoid unnecessary commutes. But it is also very important that the system has the necessary tools to remind the participants to fill the forms via automatic notifications.
And of no less importance is the possibility to send notifications to the study manager when participants had completed all or some of the questionnaires.
(Gif animado con notificaciones)
Key 3: Automatic integration with the rest of the clinical data of the study.
This key is more than recommendable.
Once the participants’ data has been collected it is highly recommended that such data can be automatically integrated with the rest of the participant's clinical data.
Doing so, the data included by the patient can be effortlessly related to the clinical data without having to recur to complex integration processes between the participant´s clinical data and the submitted data by the participant.
(Gif con los datos integrados en el EDC)
ePRO/eCOA in ShareCRF
In SharecRF we have an ePRO/eCOA tool in place which allows the patients to send the data in a secure and fast manner through our ePRO application and the collected data are automatically linked in the eCRF to the rest of the participant’s clinical data
It also allows the configuration of notifications and reminders to the participants to prevent them from forgetting to fill the forms before the indicated date.
On top of that, the forms can be configured with the same tool used for the eCRF forms, so it is not necessary to learn a new one.