A Brief History of Patient Reported Outcome Data Collection
Long ago, the industry was using paper to collect patient reported outcome. Papers were being given to patients to take home and they would manually record in a diary whatever outcome is required per protocol needs.
Data collection began moving from Paper CRF to eCRF and there was also a transition a few decades ago to using electronic systems to report outcomes in real time. More recently, patients were even given the option to use their mobile phones to access a system to enter their information via secure URL.
Enter the Convenience, Security and Reliability of ePRO
ePRO (which stands for Electronic Patient Reported Outcome) enables patients to conveniently record whatever observation needed during participation in the study, such as quality of life, symptoms, drug intake, etc. The use of ePRO has seen a significant improvement in:
- patient response and engagement,
- quality and accuracy of data, and
- reducing burden to site staff as data are collected in real time, where no data entry is required.
Accelagen proudly employs this system, as we are devoted to providing the best experience available. Using the ePRO platform, Accelagen provide patients with a unique link via their email, which leads to a very secure portal where site staff and patients can simply log in and report their outcomes within a private, secure environment. Additional features also allow for automated patient reminders to complete their assessment or confirm upcoming clinic visit, which builds on improved data collection.
The Standardization of CDISC data packaging
CDISC (Clinical Data Interchange Standards Consortium) standards are a set of guidelines used to standardize the way of collecting, organizing and communicating data in clinical trial research. These standards are used worldwide among CROs, pharmaceutical companies and even some academia.
Generally, for clinical trial data, the key CDISC standards used are the Study Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM). SDTMs organize data into specific domains (such as Adverse Events, Disposition and Demographics), whereas he ADaMs are analysis-ready datasets designed to support the further statistical analyses. The SDTM domains and ADaM datasets adhere to specific structures and variables, formats, naming conventions and terminologies, so specialized knowledge in these standards is crucial.
Accelagen Makes the Most of the CDISC Standard
All of this requires expertise, of course, but the benefit of using CDISC is that the final study data is in a standardized format so that when it comes to regulatory reviewers, it will be an easier and quicker process. This ensures efficiency and ultimately, saves time and money across studies and sponsors.
For further efficiency, CDASH standards are implemented at the data collection stage to ensure the collected data are consistent, and these form the basis of Accelagen’s eCRF library. Having these forms readily available when we’re creating datasets speeds up our build time for customers.
The Importance of Expertise AND Experience
Expertise is critical to maximise the correct application of the ePRO and CDISC technologies. An important requirement of implementing ePRO systems is the involvement of certified database developer to build the platform the specific systems being used. These developers need to be trained and certified in implementing these modules within each platform. What distinguishes Accelagen from the other CROs is the dynamic nature of our programs that allows us to accommodate whatever changes are required within the patient forms promptly.
If the sponsor has their own standards, Accelagen has the flexibility to customize the interface to accommodate these elements, but also the experience to give the customer insight on whether these elements might cause issues in the standardization of their data downstream.
For instance, some clients may not have expertise on CDISC standards when building their study, but because of our years of expertise we can tell “Yes. You can collect that, however, it will not match the CDISC standard”. Additionally, we can then take the time to explain what effect collection of specific data may have downstream, allowing Sponsors to thoroughly evaluate their options and decide what is important to the overall outcome. This input is just a small step to the value Accelagen can add to a program outcome.
The Advantage of Being Nimble (and Quick)
On top of being highly skilled and experienced as a team, Accelagen also offers the advantages that come from working with an agile group of professionals.
Our clients have come to truly appreciate our customer-calibrated approach, and our ability to respond to their needs in a project centric way… not to mention the opportunity our approach allows for studies to begin in weeks – not months.
Our size and culture at Accelagen is one that of nimble response to your needs with the heart of a teammate, rather than just a vendor. Your success is the way we measure our own success. When we begin your projects, we are more than just a hired set of hands… we are truly an extension of your team.
If you would like to experience the peace of mind that comes from knowing your studies are being conducted using the best available platforms, which are producing data via established standards from a group that is responsive to your individual needs throughout the entire process, contact Accelagen today to set up a call.