Digital capabilities provide opportunities to improve clinical trial processes—from trial design, through trial start-up, to trial conduct and closeout. But many R&D organizations are investigating the potential of digital capabilities and following a fragmented approach, resulting in “pilot paralysis” and a lack of consistent, and more impactful enterprise adoption.
At Accenture, we think there’s a better way. R&D organizations should form a holistic digital clinical trial strategy that is aligned with their science, portfolio, tolerance for risk, ability to invest and willingness to navigate uncharted territory, as well as three industry imperatives:
Patient connection and engagement
A digitally empowered workforce
Data-driven insights and decision-making
Trial design: Using data, adaptive trial design and inclusion of patient perspectives to enhance clinical trial design
Traditional clinical trials have been designed and executed to minimize certain variables and increase the likelihood of success. However, this approach often lacks flexibility and empirical assessments of successful outcomes, which has resulted in a level of failure that has held back the industry for years.
Adaptive clinical trials that leverage real world evidence (RWE), real world data (RWD) and analytics have the ability to help trial sponsors:
Target the right patient population at the right time.
Effectively communicate with sites.
Reduce delays and manual intervention.
Adaptive approaches are generally not incorporated until the execution of Phase III trials, yet earlier use of simple adaptive designs can decrease trial costs between 5 and 10 percent. It’s likely that more sophisticated adaptive design, such as adaptive dosing, could produce even greater value through increased success rates.
To design meaningful trials that improve outcomes for patients and R&D stakeholders alike, sponsors also need to interact with patients differently, to gain their insights, whether through simple protocol input or ongoing interactions through digital technologies including health records and wearables.
Trial start-up: Using digital tools to optimize site identification and engagement
Clinical trial start-up and site interactions can be significant pain points for site personnel, who are key stakeholders to clinical trial success. Fortunately, opportunity exists to digitalize these activities.
To address similar needs, companies outside pharma R&D are using artificial intelligence (AI) capabilities such as robotic process automation, natural language processing and machine learning. For example, the insurance industry is leveraging AI for simple case processing and standardized underwriting, to replace manual effort and generalized trend detection.
While our industry is exploring AI in patient safety, there is opportunity to bring similar technologies into the site selection process. By embedding these tools, sponsors could help improve quality site selection, reduce non-value added activity and reduce costs.
Digital technologies such as Web-based remote learning and investigator portals have already enabled the delivery of content and services to sites, improving site interactions. But additional value can be created with a platform approach. A platform that supports multiple capabilities and personas across an end-to-end business process, creates a single point of access for sponsor interactions and can help enable better site management and training of trial staff—activities that typically account for 50 percent of trial costs. Digital-enabled site selection and interaction can reduce these site-related costs by 10 percent.
Trial conduct and closeout: Leveraging digital tools to enhance patient recruitment and trial adherence while speeding time to database close
Effective patient recruitment is a prerequisite for successful and timely trial execution, but it does not guarantee a successful outcome. The overriding goal is to collect the right data to support submission, approval and, eventually, market access. However, participant attrition often slows trial execution and the path to approval. In fact, non-adherence, missed data capture and data inconsistencies can together lead to attrition rates as high as 30 percent.
Several digital can be deployed to better manage adherence and lessen attrition. Smartphone apps and wearable devices enable investigators and sponsors to monitor and control adherence remotely—without manual intervention and in real-time. Highly sophisticated tools (e.g., connected inhalers, digestible trackers, wearables) with electronic data capture capability will not only reduce the rate of missed data, but can help improve data quality and eliminate effort required to edit and clean.
When combined with analytic capabilities, these new sources of remote data capture and patient interactions have a positive impact on trial timelines. With improved patient monitoring and adherence, there is potential to decrease early terminations and improve predictability of trial timelines. With all these factors combined, there is potential to decrease trial cycle times and enable informed and timely decision-making.
The future is bright
By looking at patients and diseases holistically and interacting with patients differently, the digitalization of clinical trials would help:
Feed insights back into research and early development to improve disease targeting and protect future patients a burdensome trial or therapy experience.
Find the patients that benefit the most from a selected therapy and enroll them in high performing sites.
Reduce the risk for all stakeholders by identifying issues in real-time, or better yet, predicting them before they occur.
To bring new therapies to patients over the next decade and to prepare their organizations for the transformation that will come with the use of these technologies, sponsors need to define a strategy that meets their unique goals and appetite for risk. Their strategy must embrace the digital capabilities available today but continue to transform as new solutions and stakeholder expectations emerge.