WHITE PAPER Getting Connected: The Benefits of a Unified Clinical Platform December 2017
Table of Contents 01 Getting Connected: The Benefits of a Unified Clinical Platform 05 New Technologies 04 Changing Dynamics 06 Into the Future
Getting Connected: The Benefits of a Unified Clinical Platform Historic Barriers The issue of disconnected, poorly integrated systems and processes (Table 1) has long plagued clinical trial management. For nearly 20 years it has been discussed and dissected, and has been top of mind for clinical operations leaders. Point-to-point integration across multiple products has provided some connectivity but doesn t account for the need to connect the many different points of entry (Figure 1) data collected from trial participants, lab data, EDC data, site monitoring, safety data, analysis, and so on to ensure oversight, allow in depth analysis and gain knowledge about the trial data. Available Solution Clinical Data Management System (CDMS) Purpose Tool used in clinical research to manage the data of a clinical trial Clinical Trial Management System (CTMS) i Supports administrative and managerial aspects of running a clinical trial Site Start Up Tools Focus on selection of investigators and getting the sites ready for patient enrolment Electronic Data Capture (EDC) ii Collects clinical data in electronic format Randomization & trial supply management systems (RTMS) Support clinical trial randomization and associated drug supply management ArisGlobal.com 1
Clinical investigator site Portals Allow sponsors and CROs to communicate and coordinate with their sites electronically beyond EDC Electronic Clinical Outcome Assessment (ecoa) Allows patients and clinicians to directly report outcomes from clinical trials Electronic trail master files (etmf) Provides a formalized means of organizing and storing documents, images, and other digital content for clinical trials Trial Disclosure Efficiently manages clinical trial registration and reporting of results to public registries like ClinicalTrials.gov or EudraCT and submits results overview of completed trials Regulatory submission tools Supports the planning, preparation and tracking of submissions of clinical trials to regulatory agencies and IRBs/ECs. Table 1. Clinical trial management systems and processes ArisGlobal.com 2
Study Start-Up Site Portal Regulatory Submissions RBM Safety Report Distribution etmf CTMS ecoa RTSM Payments EDC Trial Disclosure Document Data Site Data Subject Data Figure 1. Point-to-point integration across multiple products ArisGlobal.com 3
Added to these challenges is the fact that clinical trials are now more complex than ever. According to the Tufts Center for the Study of Drug Development (CSDD), study protocols now have more endpoints, procedures, eligibility criteria, case report form pages, amendments, and investigative sites than 10 years ago iii. To overcome challenges, clinical operations put in place point-to-point integration, such as sharing data from electronic data capture solutions with their clinical trial management solutions (CTMS) or tallying efficacy data and safety data. Often, however, these solutions don t address the broader needs of project and risk management, partly because they fail to connect the multiple systems involved in running clinical trials and don t provide organizations with a holistic view of the entire trial. Increasingly, it s important for clinical operations to have platforms that give them a single source of truth, enable master data management to improve data quality and achieve standardization, guarantee the security and privacy needs of clinical trial data, allow for system upgrades, and enable early adoption of new technologies to support growing business needs. Without a unified platform, these capabilities can t be adequately achieved. What is needed is an end-to-end approach that shifts away from the point to point data integration, an approach that typically has been referred to as integrated, and toward a unified process integration. Changing Dynamics Today, clinical operations executives have many issues to juggle: they must ensure evolving regulatory requirements are met, they must meet trial objectives, and they must provide data that demonstrates the continued value of a clinical study to the business or sponsor. They must achieve all this while making optimal use of resources and preventing costs from escalating. Study start up has typically been time-consuming, difficult and expensive. From site identification and feasibility, to contract preparation, to patient recruitment, to managing and tracking documentation, there s a lot of work involved in starting a study. The use of electronic investigative site files (eisfs), integrated onto one platform, can simplify the process of site document control and management, as well as collaboration with the sponsor. Time and resources can also be saved by deploying risk-based monitoring because smaller teams of monitors can be deployed to handle communications. However, RMB requires modern tools to enable remote monitoring and this is typically possible with most systems in place today. From recruitment to data collection to managing variability in clinical practice, the ability to leverage connected solutions that can remove some complexities and advance research is paramount. Electronic health records (EHRs) could be a means for improving recruitment, surveillance, and clinical ArisGlobal.com 4
research iv by enabling better site selection, reducing source data verification efforts, and improving adverse event reporting. EHRs have the potential to enhance interoperability with other systems, such as electronically moving relevant EHR data into an EDC system. In guidance released in 2016, FDA noted that widespread use of EHRs created opportunities to improve patient safety, data accuracy, and clinical trial efficiency in clinical trials v. The advent of patient registry studies also plays a significant role in how technology is leveraged. Typically during clinical studies, clinical operations teams spend time methodically designing electronic case report forms (ecrfs). However, registry studies require quick turnaround of the observational data gathered from questions posed. Digital technologies are vital to enable patients to join the registry, to facilitate how the data is reported and stored and to find patients with similar conditions vi. The patient dynamic is also changing. Increasingly patients are likely to have spent time researching the disease, the drug being trialled, and the history of the investigative centers involved. These digital patients vii are engaged and interested in participating in trials and they are looking to be kept informed and involved. That can mean adding educational websites or social platforms to keep patients engaged as well as reminder tools to help patients keep track of medicine intake. It s also important to gather both quick and deep insights from the data that will assist with decision-making. For example, clinical trial managers want to be able to conduct risk-based monitoring (RBM) to better identify potential risks and determine the safety and quality of the trial. Another complexity that clinical operations must contend with is data protection. When clinical data exists in multiple different platforms and data centers, data protection can be a challenge. With the new General Data Protection Regulation (GDPR), which will be enforced from May 2018 in Europe, citizens gain greater control over their data, which means organizations must inform individuals about any data they have about them and gain their consent to process any personal data. Robust technology and procedures are a must in the clinical space. From recruitment to randomization procedures to stock management to data management and data cleansing to central data monitoring, a progressive approach to clinical trial management is imperative. New Technologies In today s information rich digitized world, there are growing opportunities to create a unified clinical platform that delivers a single source of truth and helps organizations to realize trial and business objectives. On a day-to-day user perspective, one of the big challenges with heterogeneous solutions is that each user interface is different, such as different data flows, different log ins and different look and feel. A unified platform lets users enjoy the same experience for different processes, which can reduce the need for training and optimize onboarding time. ArisGlobal.com 5
At a broader business level, a unified platform makes it possible to leverage new technologies. Automation, mobility, the cloud, and artificial intelligence (AI) are changing the face of clinical operations, making it easier not only to integrate data and processes but to leverage that data as required. Mobility, for example, makes it easy for trial subjects to report information relevant to the trial and for trial investigators to quickly share that information while on the go. The value of the cloud in the context of advancing clinical operations capabilities is in the ability to have all systems and solutions unified on one platform. Cloud vastly simplifies the task of managing and integration systems and sub-systems, and scaling based on operational needs. A further benefit with multi-tenant, cloud-based platforms is that upgrades are handled quickly and seamlessly without the need for time-consuming upgrade projects, which makes it easier to leverage the latest technologies, such as AI and machine learning. Automation: AI has the potential to enhance analytics and decision-making, but for that to happen data needs to be in one place. However, once a unified data and process platform is achieved, AI allows organizations to take analytics to the next level. Among the many use-cases for AI are: The ability to identify significant risk indicators for risk based monitoring (RBM) The ability to identify adverse event from data that originated directly from patients in clinical trials The ability to identify sites that follow a pattern different from other sites and that therefore require special attention By way of example, AI creates a paradigm shift when it comes to RBM. In the past, monitoring to protect patients and ensure quality data required frequent on-site visits. The shift to RBM sought to enhance monitoring while allowing resources to be used more strategically. To determine where a review is needed, clinical operations leaders have used rules-based data, which flag outliers or events to indicate the need for a review. Into the Future Having a unified platform (Figure 2) removes the complexity associated with trying to consolidate multiple different data points from several systems. Furthermore, with so many digital opportunities knocking on the door of clinical operations, having a solution that enables these new technologies cloud, mobility, automation, AI -- to be implemented is not only highly desirable but increasingly necessary to advance capabilities and insights. A unified platform enables organizations to maximize the value of each application and leverage its full potential in concert with other applications. ArisGlobal.com 6
Dashboard/Reporting/Analytics CTMS EDC RTSM etmf Regulatory Coding Site Portal Study Planning Study Start Up Budgeting Clinical Payments RBM Safety Reports Trial Disclosure ecoa Shared Data Model/Libraries Technology Platform/Cognitive Computing Figure 2. Unified Clinical Development Platform A unified user experience through a unified platform that simplifies integration of new technology benefits all stakeholders. Below are some of the key roles involved in the clinical process and some of the gains a unified platform could create for each group. For CRAs a unified platform helps to optimize monitoring plans, such as frequency of site visits and which sites need more urgent monitoring. CRAs also benefit from not having to enter data into multiple systems. And mobility that is enabled by a unified platform means CRAs can continue to work offline wherever they are, boosting productivity. For clinical operations leaders a unified platform provides multiple advantages, including faster study setup, improved control over clinical trials, early detection of any issues arising in a trial and optimized use of available resources. In addition, the ability to identify risk signals and trends can lead to faster, proactive interventions by study teams at sites where potential problems are identified. For senior management a unified platform provides real-time visibility as well as early detection of risk and issues, the opportunity for faster clinical development timelines, reduction in complexities and increased return on investment ArisGlobal.com 7
For data management there are opportunities to enforce data standards across multiple studies, achieve faster study set-up and the elimination of problems that arise when merging data from two different systems-an issue that typically results in having to sift through dirty, or inaccurate, data. For regulatory a unified platform means easy submission planning in terms of timelines, better resource allocation and an easier way to track all the deliverables for approval. As the pressure to achieve faster, most cost-effective results, and to tap into new technologies to expand capabilities mounts, clinical operations will need a more progressive approach to managing every aspect of the clinical trial. A unified platform is the way forward. Authors: Vitthal Gouri, Director Clinical Solutions, ArisGlobal Mathias Poensgen, Subject Matter Expert, ArisGlobal i http://www.grandviewresearch.com/press-release/global-clinical-trial-management-system-ctms-market ii http://www.grandviewresearch.com/press-release/global-electronic-data-capture-edc-systems-market iii Getz: Site Activations Hurt By Commodity Mentality, Miseta E, Clinical Leader iv Electronic health records to facilitate clinical research, Crowie MR et al, Clinical Research in Cardiology, 2017 v Use of Electronic Health Record Data in Clinical Investigations, Draft Guidance, FDA, May 2016, https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm501068.pdf vi Engaging Patients in Information Sharing and Data Collection: The Role of Patient-Powered Registries and Research Networks, Workman TA, Agency for Healthcare Research and Quality, 2013, https://www.ncbi.nlm.nih.gov/books/nbk164514/ vii Patient centric approach for clinical trials: Current trend and new opportunities, Sharma NS, Perspectives in Clinical Research, 2015 ArisGlobal.com 8
About ArisGlobal ArisGlobal is a visionary technology company that s transforming the way today s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter. 2017 ArisGlobal LLC. All rights reserved. All trademarks are the property of their respective owners and are acknowledged as such. ArisGlobal.com 9