In 2008, the Tufts Center for the Study of Drug Development estimated the total market size for contract clinical services at approximately $8.5 billion. Nearly 10 years later, market sizing estimates put the contract clinical service industry at over $30 billion. This outsourcing trend is being driven in response to the ever-increasing size, complexity, duration and cost of clinical trials. To illustrate the impact of clinical research organization (CRO) growth, headcount from major CROs outpaced those of major sponsors as far back as 2010, as sponsors strived to trade fixed for variable costs of labor through headcount reductions and concurrent upscaling of outsourced activity. According to recent research, sponsors now outsource 61% of clinical development work and anticipate remaining around this level through 2021. Continued growth in R&D spending along with increasing costs of drug development will drive spend in outsource development despite the relative proportion allocated to outsourced spend remaining flat.
Sponsors primarily outsource to CROs to control operational and infrastructure costs, allowing them to concentrate on what they do best – drug development. Although there are obvious benefits to outsourcing, it creates new challenges around quality, oversight, collaboration, and governance. With outsourcing, processes and systems are often duplicated or disparate. Sponsors, CROs, and sites use their own SOPs and processes, resulting in duplicated effort and data entry.
Additionally, there are challenges around CRO and site benchmarking and governance. Sponsors can’t benchmark CRO and site performance across their studies and therefore are unable to build-up institutional knowledge and competitive business intelligence, nor can they monitor ongoing performance to identify potential bottlenecks, having to rely instead on scheduled, and frequently outdated, status reports. Separate systems can also pose latent compliance risks. What is needed is a unified eClinical ecosystem for “trusted collaboration”, which facilitates centralized communication and collaboration in real-time in order to keep all stakeholders aligned on shared goals and processes.
Redundant processes increase the time required to complete tasks, with incurred delays increasing costs. These redundancies occur most often when sponsor and CRO SOPs require that they perform the same task; without visibility into each other’s processes they unwittingly perform the same work.
Collaborating organizations should document, share, and compare their internal processes to identify such redundancies. Documenting processes using a workflow-driven process automation application helps teams visualize and analyze processes. Efficient, repetitive processes supported by intuitive data systems and specialized teams concentrates resources and the right talent where it’s most effective.
Systems that track how studies unfold are essential but putting that information to good use requires turning real-time visibility into actionable data. Performance metrics must be data-driven, standardized across studies, indication, and therapeutic areas, and timely. They must also, importantly, facilitate a forum for discussion. By utilizing a trusted ecosystem for collaboration stakeholders can proactively identify bottlenecks and have meaningful discussions. These interactions can solidify the engagements for CROs and change the mindset from that of a commodity to strategic partner for sponsors.
Communication and transparency are required to move a clinical trial forward efficiently, but how can you do this when you’re working with multiple CROs or sponsors all using inconsistent reporting conventions? Defining a data dictionary that defines how study performance data is used and interpreted is critical to achieving data integrity. This data should also be shared to prevent duplications and inconsistencies between sponsor and CRO. Quality performance data enables all parties to analyze metrics and make solid data-driven decisions, often in real-time. If required, APIs can be used to integrate disparate systems to enable partners to connect their systems to facilitate sharing, thereby decreasing the potential for errors resulting from inconsistent data handling or analysis.
Organizations that have clear processes and expectations can more effectively train staff and realize repeatable, consistent results. For example, the process for a protocol approval for the German regulatory authority does not change frequently. If an organization doesn’t have this process well documented, each person that manages a protocol in Germany must research and interpret the authority’s regulations and those of the CRO and/or sponsor organization; this could lead to lack of compliance with the submission, lost time, and costly mistakes. Operational performance can quickly be improved by utilizing a library of standardized country workflows for quick study activation.
During the site identification process, sponsors and CROs often request information already provided by sites during previous trials. Maintaining a consistent, supervised database of site performance metrics, such as site startup cycle times, site ethics requirements, facilities, capabilities, and staff documents and details can enable easy access to site information and deliver a more efficient, data-driven and targeted site selection process for sponsors and CROs.
As outsourcing continues to be a clinical trial mainstay and an integral component of clinical research, sponsors and CROs must collaborate in ways that look to build upon the strengths of each organization by utilizing information and resources in a more uniform, consistent manner. Systems that centralize clinical activities are imperative in this pursuit by providing real-time insights into process workflows, supporting regulatory and SOP compliance, and driving meaningful communications and collaboration across organizations based on a foundation of mutual trust.
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