September 1, 2015 LSL-M09-15-NI-001
When asked which technological advancements adopted by CROs/CMOs have the greatest potential to provide cost and time savings, 62 percent of respondents indicated that cloud-based data management services are important. Mobile-based innovations for recruiting and communication with patients and mobile technology for remote monitoring were each also noted by 38 percent of respondents.
A potential outsourcing partner’s level of technological innovation is one of the areas survey respondents listed as being important. In addition, they also consider the partner’s use of advanced technologies to enhance safety and improve efficiency, security, regulatory compliance, patient compliance, speed, loyalty, and traceability to be important.
Survey respondents also ranked quality control, R&D, manufacturing, distribution, and labeling and packaging as respectively having the greatest to least potential to benefit from technological innovation.
The global clinical trial service market will reach $64 billion by 2020, growing at a compound annual growth rate of nine percent from $38.4 billion in 2015, according to Research and Markets. In addition, a U.S. Department of Health and Human Services report from July 25, 2014, stated that by 2020 close to three-fourths of clinical trials (72 percent) will likely be performed by professional CROs.
This growth in outsourcing of clinical trials is driven by several factors. First, the number of clinical trials is growing dramatically — approximately 33-fold since 2000, according to the National Institutes of Health. Second, clinical trials are becoming more complex than in the past, with many performed on a global scale at multiple sites for longer periods of time.
This growth is also reflected in the results of the Nice Insight survey when looking at the needs of emerging and start-up pharmas. More than any other activities, respondents indicated they would be outsourcing clinical research and clinical monitoring (32 and 30 percent, respectively) in the next 12 to 18 months. Biostatistics and data management also ranked fairly high, with 29 and 26 percent of respondents expecting to outsource these services, respectively.
Analytical (e.g., analytical and bioanalytical testing, chemistry and stability testing, microbiology, product and particle characterization) and biomanufacturing services also ranked high, with 30 and 29 percent of participants anticipating the outsourcing of these activities.
In its January 2015 21st Century Cures Discussion Document, the Energy and Commerce Committee of the U.S. House of Representatives identified five key issues that must be addressed in order to accelerate the discovery, development, and delivery of promising new treatments and cures for patients, one of which is the need to streamline clinical trials. As a first step, the committee suggested the industry pursue broader adoption of adaptive clinical trial designs aided by innovative technologies and statistical modeling.
The July 2014 report, Examination of Clinical Trial Costs and Barriers for Drug Development, also determined that in addition to expanding the FDA’s priority review process, the high costs of clinical trials could be reduced by leveraging lower-cost facilities and in-home testing combined with the use of mobile technologies and EDC, which were estimated to reduce trial costs from 8 to 24 percent across all phases.
Larger and more complex clinical trials generate large quantities of data that must be collected, monitored, and managed. Advanced software systems, such as Merge eClinicalOS from Merge Healthcare and BioClinica’s eClinical platform, can help ensure not only efficient data collection, but also data accuracy and control. Information technology platforms with advanced data management tools provide real-time visibility combined with the ability to process, analyze, and evaluate the data and instantly share results with relevant stakeholders.
The FDA, in fact, supports the use of EDC systems because they benefit everyone involved in clinical trials, from sponsors to investigators to patients.
Compared to traditional paper- and spreadsheet-based approaches, these systems provide more accurate data that can be more easily shared and monitored, and they offer increased compliance with regulatory requirements and lower overall costs. The agency also encourages the use of advanced data management tools that enable adaptive trial design, which has been estimated by the Tufts Center for the Study of Drug Development to save sponsor companies between $100 million and $200 million annually through early termination of unsuccessful studies.
Such tools include cloud-based data collection and storage systems, programs that enable real-time data monitoring, data analysis tools for real-time and continual evaluation of results, and security systems for data access control, among others.
Trial planning and study build-out and start-up are also simplified with EDC solutions because it is possible to establish timelines, determine the required number of sites, and define responsibilities for different staff members across multiple sites at the outset.
As importantly, there is no need to create paper case report forms (CRFs) or keep track of thousands of pieces of paper, and the data is centrally located for easy searching and analysis, which enables early identification of trends and significant outcomes. Communication among all parties is also enhanced, which means that problems are caught and addressed before they become major complications.
Several studies have confirmed the benefits of EDC systems. Cost savings have been found to result from the elimination of on-site monitoring, the reduction of the time required for cleaning up data errors, and the lowering of general processing costs (Global Clinical Trials: Effective Implementation and Management). In another study outlined in the 2011 Thompson Reuters report, Information Technology Is Improving Clinical Practice, more than 300 trial days were eliminated on average following the implementation of EDC systems.
Cloud-based EDC systems are ideal for the complex, multisite clinical studies being performed today, because all information (study protocols, patient data, images, outcomes, etc.) is stored in a central location and maintained by a third-party service provider. The data can be input from any type of Web-based device, including smartphones for easy patient reporting, and is automatically updated and collated for more rapid and efficient data monitoring. The most advanced cloud-based EDC systems also include capabilities for tracking the drug supply, managing images, and coordinating reporting, translation, patient education, and other activities that go well beyond simple data capture. Because there is no sizable up-front investment with cloud-based EDC systems, organizations of all sizes can benefit from the advantages of increased efficiency and productivity.
Today’s pharmaceutical manufacturers are constantly faced with driving down costs and improving product performance (e.g., efficacy, ease of use, patient adherence). Consequently, more clinical trials are being outsourced, but at the same time, the costs associated with conducting even outsourced clinical trials have increased.
Innovative technologies that range from cloud-based data management systems to increased automation for production and analyses are, therefore, attracting significant attention, as indicated by participants in Nice Insight’s survey. Cloud-based EDC systems combined with mobile and wearable technologies, most notably smartphones and smart watches to date, are beginning to have a real impact on improving efficiencies and lowering costs, and sponsor companies are attracted to CROs/CMOs that recognize and leverage such state-of-the-art data management solutions.
Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.