As Clinpal launches another global registry study, it is interesting to examine how technology is acting as a catalyst in how we engage patients in clinical research.
Observational studies by their nature are often long term, extend over diverse geographies and operate within tight cost constraints. Add to that, the fact they often involve extended gaps between patient visits. Patient retention and cost effective data quality management can be challenging.
I would like to share a few insights on how we are seeing technology as an enabler for observational research that was simply not achievable until recently.
Patient Engagement & Reminder Dashboard
It is not uncommon for patients to ‘forget’ that they are actually participating in a clinical trial, especially if their involvement is limited to every 4-6 months, as is common on long term OBS studies. To tackle this, we created a personalized dashboard environment that provided each and every patient rolling updates to the clinical trial, their activities, and their overall progress. This also doubles as a reminder ‘focal point’ that is triggered through different means of communication (SMS, Email or App). The patients are sent a quick reminder prompt – they click on it to securely see information on their participation on their dashboard.
Targeted Data Cleaning
Regular query management can be expensive. So we invented the ‘Super-Soft’ query. This is a query that is raised to the investigator who in turn has the means to confirm a response. Used in combination with traditional hard and soft queries, we have applied a risk based automatic data query management process optimized for observational trials. This is less disruptive for the sites, and less costly to monitor for non end-point data.
Not to be confused with an adaptive protocol – an adaptive eCRF only captures the data needed for the trial under the circumstances defined by the protocol and the data entered up to that point in time. For example – capturing ‘Any relevant Medical History’ might be appropriate for a Phase III trial – but with OBS, it is better to target the definition of ‘relevant’ by capturing the correct data in the first place. The eCRF is also highly interactive – it is worthwhile spending more time on the ‘in page’ dynamics that on the extensive DM & Monitoring work across potentially ” 1000’s ” of patients.
Keeping it Simple
One of the most important, and under valued aspects, is keeping the technology that supports a clinical trial as simple as possible. A single system, across multiple devices (BYOD) performing all of the activities required for the trial creates an environment that is not only easy to setup and manage, it is also easy for site staff to operate considering often infrequent usage with long term studies. In a typical OBS study,
Clinpal includes the following (modular) elements:
- Dashboards for all users
- Adaptive Data Capture (inc Monitoring support)
- eLearning – automatically controlling site user access
- eLibrary (for sites and patients)
- BYOD ePRO
As we launch another registry, it is clear that some observational studies, that were not possible even as recently as 3-5 years ago, are now both achievable as well as affordable. Patient engagement is no longer just a nice to have ‘bolt on’. Patient engagement can be considered an integrated element of a successful study.
Happiness is an engaged patient!