Amidst Pandemic or Post – Decentralization a Necessity with a Patient Centric Approach
Conduct of clinical research relies heavily on the successful completion of many ongoing and future clinical trials. In the current pandemic situation, decentralization (remote) seems to be the only way to achieve the completion of these clinical studies.
Unless the clinical study is intensive with requirements of specialized hospital equipment’s like a CT/MRI scanner, etc, the clinical study visits could be completed at the patient’s home by using local/mobile healthcare and a telemedicine platform. It is one part to conduct the patient facings aspects remotely, collecting good quality data is another part, which requires utilizing on the edge technology which may not be ready for prime time, but will become the main process flow for future.
This would include, several existing procedures being managed electronically (e)
- eConsent
- eSource files
- eCase report forms (eCRFs) ideally integrated with the eSource files
- Remote monitoring, as on-site visits would be limited
- Risk/100% based real time monitoring, merging with stats and given direct access to data a more real time review of the date being collected to ensure good quality
- eClinical Out Assessments (eCoA) including clinician and patient reported outcomes
- eDiaries
- eLearning centers to offer training to study site staff based on their involvements, and for patients on the new things that they need to learn
- Specialized contactless deliveries for equipment’s, investigational products, etc
It would also make it possible to have tertiary care centers that can perform a part of the specialized cares that are needed, as a few massive corporations are converting their brick and mortar areas towards healthcare.
While bring your own devices (BYOD) is not a preferred approach, given the versions that one needs to develop to support the different types of devices that the patients may have, it might be the simplest way, and worth the innovation of creating applications that can support the above electronic (e) functionalities
On the back end, the randomization and trial management system (RTMs), electronic data capture system (EDCs), supplier portals, clinical trial management systems (CTMs), telemedicine platform for source capture, etc, and creating an all integrated system would be the ideal set-up.
It is an exciting time in the life science industry as the field is moving towards a logical solution of decentralized clinical research that has been in the works for a few years but has been pushed to the forefront with the pandemic. While there remain concerns on best practices, only remote interaction with patients, or a hybrid approach, elements of risk, management of compliance and data quality, which are all expected as a phase of implementing a transformative idea. I do believe that the biggest winners would be the patients, as the entire approach is a patient centric approach, which would go a long way in recruitment and retention of them in clinical studies.
