Patient-reported-outcomes (PROs) can not only be utilized to present patient medical history; but also indicate biometrics that can be integrated with clinical trial data within a scalable, secure framework. Adopting ePROs (electronic patient-reported-outcomes) as a supporting arm of patient-centric care can complement previously recorded clinical data while also providing a complete roadmap of patient health; thus supporting clinical development and ongoing care. Through ePROs, capturing valuable treatment progress information in between medical/clinical appointments can also indicate steps towards successful preventative and chronic care management. This data can then be captured electronically through EDC (electronic data capture), steering away from paper-based CDM.
Implementation in a clinical setting
ePROs have the capacity to benefit patients, clinicians and researchers alike by supporting simple integration of patient-generated data into core clinical systems. Additionally, this facilitates safer, more holistic care through the sharing of broad clinical information. It is also possible to bring in both patient-reported data as well as objective, biometric data and eventually perform analytics on these two data sets for more accurate results. It is important to note that active patient monitoring requires an FDA Class II certification and 510(K) clearances1 in the US; hence certification can be an expensive and lengthy process considering tight clinical budgets and short timelines.
Innovative patient engagement devices can facilitate the production of important data outside of standard ePRO frameworks and data can be shared with providers to expand the depth and stability of data available to improve patient care and outcomes. The submission of ePROs and access to patient/trial subject portals can offer innovative ways to connect patients, and strengthen patient engagement related to their health and wellbeing.
Patient monitoring devices – bring your own device (BYOD)
Leveraging patient-reported data from mobile health (mHealth) devices and applications has the potential to successfully support clinical research. mHealth devices such as PDAs (personal digital assistants), smart phones and tablets may be integrated with clinical study data in order to provide a comprehensive understanding of the patient/trial subject’s progress. This can be achieved through integrating lab information, clinician-reviewed vital signs and inclusion of any adverse events. The devices are easy to use and support end-to-end data integrity from point of origin to point of use. Presenting patients with mHealth devices drives forward real-time clinical support and unearths new study endpoints that can expose digital biomarkers, thus providing a better understanding of patient outcomes and disease progression. Furthermore, patients can have a more engaging clinical experience with reduced site visits. Researchers can help identify which mHealth device is most practical to improve health and care processes, yet more education is required to support ease of use and adoption clinically. Establishing how to assimilate mHealth tools clinically is paramount to innovation of patient engagement. It is important to note that In addition there are also costs associated with managing healthcare devices, and receiving them from patients after the trial programme is concluded. This can add strain on return on investment if not managed efficiently.
Data privacy considerations
The emerging success of patient engagement unavoidably highlights potential challenges related to compliance with data privacy protection laws. When capturing, processing and utilizing personal data through ePRO or mHealth, it is crucial to avoid breaches in data privacy. In order to avoid liability, it is fundamental to comply with EU Data Protection, Safe Harbour and HIPPA (Health Insurance Portability and Accountability Act) regulations2. Aligning internal processes to ensure compliance with these regulations also assures patients that their data is secure, and as a result can abolish a key barrier to patient enrolment in clinical trials. Researchers must ensure their vendor partner(s) also adhere to any country-specific regulations.
Key considerations for patient engagement moving forward
Harnessing a more objective and subjective approach to patient engagement can not only benefit clinical trial enrolment but also trial execution. While all study plans are not yet optimized for incorporating ePRO and mHealth, it is important to the development of clinical trial processes to leverage such tools moving forward. Patients are already involved in purchasing their own devices to monitor their health and wellbeing, so this paves the way for capitalizing on this for clinical trials. Patient-reported data is significant to the future of the clinical arena and managing this through proactive data integration supports the success of clinical trials.
1 – http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/
2 – http://www.export.gov/safeharbor/eg_main_018238.asp
