Study delays are a common and costly problem in the world of clinical trials. Today, with the COVID-19 pandemic significantly impacting trial enrollment and stranding many trials, it is more important than ever to make operational study plans as predictable and controlled as possible. Sponsors and CROs can achieve this goal and accelerate trial delivery through data-driven digital tools and solutions.
Transformational digital technologies provide assistance in four key ways:
- Patient recruitment. Patient recruitment tools identify, qualify, and enroll patients from the public domain and enable healthcare organizations to qualify their own pool of patients. This takes the burden of patient matching off the study sites and lets them focus on their core competency: the clinical evaluation of patients.
- Patient engagement. Patient engagement solutions improve patient retention by simplifying communication between patients and the site, keeping patients well informed, driving patient motivation, and – of great importance – encouraging patient adherence to treatment and compliance with procedures.
- Risk assessment. Analytics software can help quantify operational, commercial, and technical risks in drug development projects and portfolios. This gives a clear understanding of potential problems and opportunities downstream, leading to better, more informed strategic decisions.
- Study development. Scenario simulations help optimize the design of a clinical study by demonstrating how various factors (e.g., recruitment rate, time to activation, number of sites, budget considerations) may impact the delivery time of the study. Multiple scenarios can be modeled to see how to accelerate the completion of a specific study.
Digital tools are beneficial beyond the initial stages of a trial. As real-world data is gathered during the course of a study, it can be leveraged to further refine patient recruitment and engagement tactics, assess emerging and ongoing risks, and support agile decisions to shift the study’s delivery timeline or reduce costs. For instance, look-alike modeling can leverage data about current study patients to more quickly recruit qualified candidates. As another example, data about actual site performance can be entered into a simulation to assess whether or not additional sites need to be added.
As sponsors and CROs launch new studies and restart stranded studies, transformational digital technologies will play an even more crucial role than ever before in ensuring that studies can be completed successfully. Integrating tools such as those described here will give organizations the edge they need to mitigate risks, condense timelines, meet budgets, and make decisions to get ahead of the curve. In doing so, they will be able to streamline the development of therapies and treatments that can change and save the lives of the patients they serve.
To learn more, view the on-demand webinar “Minimize the Impact of Trial Disruptions with RWD-Driven Digital Recruitment and Operational Scenario Simulations.”