Since being officially condoned by the FDA in 2013, Risk-Based Monitoring (RBM) has progressed to become a viable clinical monitoring technique, leveraging the latest technology to proactively identify challenges to trial safety, data analysis, and compliance. With clinical trial resources prioritized by risk, RBM has brought study sponsors, CROs, and other stakeholders greater oversight into how trials are conducted.
Based on the effects that social distancing and quarantine are having on current and upcoming clinical studies, decentralization offers many benefits over the traditional approach to clinical trial execution – leveraging digital technology and home health to facilitate site-less trials and patient-centric protocols.
As digital therapeutics are integrated into every aspect of the healthcare landscape, patients, payers, and providers are seeing an increasingly complex set of software-driven therapy options reaching the market. This rapidly expanding field has enormous potential but faces challenges at every stage, from design to patient perception. Focusing on the clinical trial stage, how does the trial of a digital therapeutic compare to that of a pharmaceutical? What are the specific challenges of running a digital therapeutics clinical trial, and how can sponsors adapt their approach for the highest chance of success?
Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.