P247: Multimodal Digital Remote Patient Monitoring (RPM): The Development of Solutions for Adverse Events of Special Interest
Poster Presenter
Michael Trulli
Associate Director, Science Capability and Delivery
Evinova United States
Objectives
We describe the multi-disciplinary development, content validation and implementation of four digital solutions for monitoring toxicities in oncology trials with the goal of keeping patients on efficacious treatment.
Method
We convened a multidisciplinary team (data science, clinimetrics, behavioral science, design, device regulatory and safety) and conducted literature reviews, qualitative interviews with patients and clinicians and consensus experts panels to inform best practice for RPM solutions in trial settings.
Results
Symptomatic adverse events of special interest (AESI), Pneumonitis, Stomatitis, Rash, and Dehydration due to Vomiting or Diarrhea, were prioritized based on incidence, morbidity, and treatment dosing impact (delay, reduction, interruption) in a tumor and treatment agnostic manner. Functional definitions of AESI were informed by (i) review of the published clinical guidelines for toxicity monitoring, diagnosis, and treatment, (ii) an expert panel using qualitative consensus methodology, and clinically validated during semi-structured focus group interviews and individual interviews with oncology nurses and health care providers (HCPs). These functional definitions accompanied by the CTCAE grading criteria informed the data collection and data visualization requirements as most relevant for monitoring the emergence or worsening of symptoms attributable to toxicities. Clinical data to be reported by patients includes symptom incidence, severity, and limitations on activities of daily living (ADL). To provide additional objective clinical data, physiological biomarkers including vital signs (blood oxygenation) will be captured through sensors on medical devices including wearables and pictures of the dermatological or mucosal affected area(s) captured through camera from smartphones and anonymized. Patients confirmed that the interfaces were fit for the purpose and could enable sustained engagement. Patients appreciated the opportunity to receive education on these toxicities and be able to track symptoms. Testing with HCPs did not surface any risk of misuse such as inferring diagnosis or grading or management of the AESI. Review of statutory requirements for adverse events reporting and Software as medical device drove the characterization of the digital RPM solutions and regulatory framework for clinical trials implementation as simple data collection and data transfer non device solution.
Conclusion
Clinical data can now be collected outside of clinical sites without HCP supervision via sensors and digital application. This opens the potential to process and transmit insights regarding the patients’ health status including emergence of AESI in real time to decisions makers.
Four RPM digital solutions for the remote monitoring by HCP of symptomatic pulmonary, digestive, dermatologic, and mouth and throat toxicities were developed and content validated with patients and site HCP personnel. These solutions were implemented in oncology clinical trials supporting 3,000+ patients to stay on optimal dose and HCPs to deliver monitoring requirements for AESI. In addition, although in the absence of clinical evaluation, the data collected on these RPM solutions cannot be considered safety data, such data can support more granular insights for toxicity evolution and as such can be leveraged to inform endpoints to document the patients’ experience with treatment tolerability, and supplementing investigator reported toxicities.
The blueprint for these solutions includes a patient interface to educate patients to recognize, track, capture or report vital signs and symptoms relevant to the toxicity of interest. The data collected through patient app inform immediate surfacing of coping tips to support the patients with pragmatic steps to minimize impact of toxicities on their quality of life including nudges to contact their HCPs. The HCP interface displays the data collected via patient interface for quick insight on selected patient-reported parameters collected in between clinic visits.
Usage analytics are captured to support upcoming documentation of the clinical utility of solutions for the monitoring of AESI including impact of more engaged patients to secure trial engagement, and opportunity to prevent evolution towards high grade toxicities and related impact on treatment dosing.
