Advances in AI, digital technology, and wearable devices have played a vital role in accommodating the social distancing restrictions during the COVID-19 pandemic. Emerging digital clinical measures enable clinicians and researchers to maintain continued support for patients and healthcare systems. However, organizational barriers often slow the advancement of the adoption of digital clinical measures. Here are some ways experts can help you overcome the obstacles.
Gain Acceptance by Regulators or Payors/HTAs
Regulators and payors now expect to see complete Real-World Evidence (RWE), biometric, patient compliance, ePRO, and eCOA data presented supporting the submissions and competitive claims. Adding a validated digital clinical measure to this rich, patient-centric evidence maximizes the probability of regulatory and commercial success for drugs, devices, and therapies of all kinds.
Minimize Financial Barriers
Digital clinical measures may increase the cost and complexity of a clinical trial. However, the actual cost would be to risk not having this essential patient data. For this reason, RWE technologies are often deployed in sub-studies or as exploratory measures to minimize the budgetary impact.
Acquire Capabilities, Expertise, or Analytic Solutions
When technological and human resources are scarce, an end-to-end solution for all aspects of wearable sensor data is necessary. Engaging with a specialized, outsourced team provides efficiencies of experience and scale.
Obtain Senior Level Buy-in/Support or Budget Limits
Senior-level executives are hesitant to buy into the adoption of digital clinical measures due to a lack of knowledge and perceived budgetary constraints. Developing a comprehensive feasibility plan increases acceptance and maximizes ROI for your drug pipeline.
Increase Awareness of Potential / High Perceived Risk
The current pandemic has increased the awareness and acceptance of enabling technologies in regulated clinical trials and healthcare research. Improving patient outcomes and quality of life through innovation has never been more critical. By leveraging innovative technology, you can measure clinically meaningful aspects of patient health.
Overcome the organizational barriers that can slow the adoption of digital clinical measures. Talk to us about how our wearable sensor data analysts and digital biomarker development experts can become a valuable extension of your team.