The Clinical Trial Management System—The Central Intelligence Hub Henry Levy
Henry Levy is the Managing Partner for Accenture’s Life Sciences R&D Practice in Europe, based out of Zurich, Switzerland. Henry has worked in the Pharmaceutical Industry for the last 17 years, providing services across Strategic Consulting, Technology and Outsourcing to most top 20 biopharmaceutical companies. Henry has focused on helping sponsors achieve high performance in driving new therapies to the market. Henry is considered an industry expert in the clinical trial process and speaks often at key industry conferences.
Evolutions in technology, such as point-to-point data integration and centralized data capabilities, are enabling clinical trial management systems (CTMS) to increase the value they add as pivotal tools for streamlining clinical development operations. Accenture believes that collaboration functionality, bringing clinical trial stakeholders closer together, and the use of analytics to drive improved insights into the clinical trial progress, are major drivers of the evolution in the CTMS environment. CTMS is in a prime position to support critical decision-making by becoming the central intelligence hub in an integrated eClinical system that serves the needs of all stakeholders in the process. Furthermore, Accenture asserts that CTMS will also support clinical trials of the future by offering greater insight into the drug development process.
The biopharmaceutical industry is experiencing a challenge; as research and development (R&D) expenditure within the industry has increased tenfold over the past twenty years the number of new drugs approved continues to be flat or, as is the case recently, to decrease.1,2 Moreover, it is Accenture’s opinion that the continued merger and acquisition activity will not be enough to address the long-term impact on the industry’s valuation in the market. Therefore the situation has forced the industry to become highly focused on cost reduction.
Current clinical trials expenditure accounts for approximately 60 % of the total development spend, with the development spend itself accounting for 70 % of the overall R&D budget.3
overall expenditure allocated to the clinical trial process,4
improvements in clinical trial execution and productivity, coupled with how clinical trials are managed, has now become a key area for the biopharmaceutical industry to optimize and address. The industry must shift from a pure cost-reduction model to focus on innovation-driven efficiency. The main question to be answered by the industry is: ‘How do I get more done without increasing resources?’
The Merging eClinical Ecosystem
Accenture finds that clinical trials are supported by a variety of technologies that capture, process, and share data. CTMS is one of the many components alongside different technologies in the clinical development infrastructure, such as clinical data management systems (CDMS), electronic data capture (EDC), electronic patient reported outcome devices (ePRO), interactive voice response (IVR), laboratory processing, statistics and programming, and various submission components.
1. 2. 3. 4.
These elements form the interconnected environment that can be identified as the eClinical ecosystem. It is an environment in which high-quality data is of the essence. At its end, it must support the analysis required to provide a safe drug for the patient population but, through the clinical development process, it must also help the industry in maximizing investment by driving the highest efficiency process possible.
With 40–50 % of the
By having an ecosystem in which information can flow, data can be taken and used not only for analysis but also for management to comprehend the trial progress, as well as trial-specific predicted events. In essence, within the eClinical framework the technology components need to enable two fundamental processes:
1. data handling (data management, data analysis and reporting, data analytics, and data mining); and
2. trial management (planning, execution, management, and decision making).
Accenture notes that advances in data warehousing and data analytics technology are enabling the evolution of data hubs that can support data handling and the creation of operational data marts that better support trial decision making. With these capabilities in place, the two focal points—one data focused and one execution focused—can come together and CTMS can become the operational ‘heart’ of the clinical trial process. The direction of future approaches will determine just how much CTMS will gain in strength as it is established as the master system within the eClinical infrastructure.
Baum A, et al., Pharmaceuticals: Exit research and create value, Morgan Stanley Research Report, January 2010.
NMEs Approved by CDER. Available at: www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM247465.pdf
(accessed June 2011). Pharmaceutical Industry Profile 2010. Available at: www.phrma.org/sites/default/files/159/profile_2010_final.pdf
(accessed June 2011). DiMasi et al, The price of innovation: new estimates of drug development costs, J Health Econ, 2003;22(2):151–85.
© TOUCH BRIEFINGS 2011
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