Johnson & Johnson is arguably the world’s largest healthcare company, with over 140,000 employees globally and bringing in over $90 billion in revenue annually. Central to its business is carrying out innovative clinical research, the practice of determining the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
However, clinical research is an expensive, complex and broad practice that requires analyzing millions of data points, across multiple systems and stakeholders. Johnson & Johnson is on a mission to improve the experience of this process for clinicians, as well as broaden its capabilities in this area and introduce efficiencies.
It is doing this through the use of a new system called ClinApp, which it has built on Pega’s low-code, automation platform, Infinity. Speaking at Pega’ recent annual user event, Susan Knippenberg, Johnson & Johnson’s Director of Clinical Operations Strategic Projects, explained why ClinApp is important to the healthcare company’s clinical research ambitions. She said:
New drugs and medical devices require extensive clinical evaluation to confirm safety and effectiveness before being approved for human use. Clinical Trial development follows a detailed regulated process, including development of a clinical protocol, which describes study design, participant entry criteria, information collected via data endpoints, study timings, and additional details. The road to approval can be lengthy, expensive, and very complex.
The average number of clinical trial endpoints has been rising 6% annually since 2003, with the average protocol generating more than 20 unique endpoints. This may translate to millions of data points collected over the course of a study. Numbers of protocols, study sites and patients have also increased significantly. In recent years, the planning and execution of clinical trials has increased in complexity due to multiple factors, including changing regulatory requirements, a high volume of operating procedures that vary by study type, and multiple systems used to manage clinical studies.
This complexity creates challenges, including getting study information and updates when needed, delayed communication and duplicative information across the systems. As the clinical environment and associated complexities continue to grow, it can become harder to maintain adequate oversight of clinical related activities, such as subject enrollment, monitoring visits, action items, and documentation.
Knowing that complexity is increasing in clinical research, Johnson & Johnson reached out to clinical study managers and other stakeholders to better understand current bottlenecks and frustrations with clinical research. The findings from this stakeholder engagement were that researchers have to log into multiple systems to get work done, that there is time consuming communication and follow up with the study site to ensure that no steps are missed, that there are too many documents to manage, and that there was generally a lack of intuitiveness in the current study management system. The whole process needed to be streamlined for a more effective and efficient workflow.
This research led to the creation of ClinApp, a new user-focused platform developed by Johnson & Johnson and Pega, which aims to provide the integration of knowledge processes, systems and data. Knippenberg said:
ClinApp reduces the complexity of work, and then enables the efficient planning and execution of clinical trials. The improved operational oversight seen with ClinApp also helps ensure compliance. ClinApp’s intuitive interface will create efficiencies around onboarding, training, planning and execution of clinical activities, along with reducing costs associated with monitoring. The user experience with ClinApp is also a critical differentiator compared to what is seen across current available systems.
Pilot to production
Prior to full production, Johnson & Johnson has developed a ClinApp pilot to focus activities associated with monitoring. The pilot has three key deliverables: operational efficiencies via a user friendly interface; creating the monitoring visit confirmation letter, exiting the monitoring visit and the monitoring visit report; and generating the visit follow-up letter.
ClinApp aims to provide a single user interface between the end user and clinical systems that impact monitoring activities. This includes an interface for calling study information, and also for document archival. The app will also provide on-demand access to study-related documents including SOPs, regulation, and study materials. Long-term, Johnson & Johnson anticipates that ClinApp will be used from study start-up all the way through to close out.
Also speaking at the event was Johnson & Johnson’s Business Technology Leader, Robert Spicer, who has been managing the development of the pilot. Commenting on the company’s choice of Pega, he said:
Choosing IT platforms and partners is a long, challenging process. After several months of evaluations and deliberations, we chose the Pega Infinity platform to deliver ClinApp because it enables us to overcome several technical challenges. It also provides a unified user experience, while being flexible enough to accommodate study specific details required to support pharmaceutical, medical, technology, vision care, and surgical vision users across Johnson and Johnson
Pega also enables users to manage business rules without requiring IT involvement for every change. Pega integrates with a complex and evolving landscape of systems with a variety of technologies and capabilities. We partnered with Pega professional services from early concept ideation through analysis, design and delivery. They assembled a global team of qualified and dedicated business architects, systems architects, and user experience designers to collaborate with Johnson & Johnson subject matter experts throughout our journey.
Johnson & Johnson is using Pega case management, business process management and low-code capabilities to build the ClinApp solution. It also utilizes Pega’ Cosmos UI design system to build the single user interface. To streamline user workflow, Johnson & Johnson has applied Pega’s business rules framework, to help address and manage variations and processes across sectors. It has also deployed Pega’s business intelligence exchange and API tools to connect with systems across the applications ecosystem. Spicer said:
Pega’s support of all modern API integration standards enable us to integrate real time with our internal and external transactional systems. We leverage Pega’s business intelligence exchange to extract large data volumes for analytics and reporting.
We are confident that ClinApp will delight our users and we look forward to expanding and extending beyond the scope of the initial pilot. We are looking forward to exploring how their capabilities offered within the Pega platform can be used to impact the future of clinical operations at Johnson and Johnson.
The future of clinical research
The initial ClinApp pilot will include 11 studies across the pharmaceutical, med tech and surgical vision sectors of Johnson & Johnson. It is hoped that it will result in reduced time to complete tasks, less redundant work, improved compliance and a better user experience. Knippenberg added:
To ensure a successful pilot, robust change management, communication and training plans. have been put into place. This includes pre-launch communications, interviews, fun videos, and messaging from Johnson & Johnson leadership. Training will be live and interactive. Information about ClinApp will be maintained on the landing page as well.
The team also has cross sector champions and coaching to address questions and issues in a timely fashion. We anticipate ClinApp will become integral to a user's daily workflow. Stakeholder discussions are also underway with Pega and our internal work streams to identify future opportunities.
The initial ClinApp development took six months and Spicer said that the company learned a lot from the experience. He explained:
Customer journeys are invaluable in setting the direction of your solution. Get to the detail as soon as possible by clearly mapping out processes and keep them updated as you learn more. Confirm requirements from multiple sources and shape them with your architects, make sure you have a sufficient backlog of stories before engaging developers.
Also, identify potential integrations and ensure that they're in place before you start your build. Integrate testing into the development process from the very beginning and allow extra time for quality reviews. Include sufficient time and resources to support additional compliance requirements and documentation needed.
And finally, keep stakeholders actively engaged throughout the process and don't neglect change management communication plans. Over the next few months we will evaluate ClinApp for both capability and expansion.
Our first pilot study will go live in the summer of 2022 after which we will measure and analyze key metrics throughout the remainder of the year with the goal of scale up in the first half of 2023.