Mark Shapiro, Executive Director, Clinical Development, Clinipace Worldwide
Drug Discovery & Development - August 24, 2010
In traditional models, clinical trial functions such as project management and data management are conceptualized and operate independently, each with its unique budget, systems, and software. The independent systems and software make cross-talk among functions difficult and integration among applications expensive. In essence, no one sees the “big picture” of the study until long after the study begins. The end result is widespread duplication of effort and frequent miscommunication. Opportunities for efficiency and cost savings are lost as information is imperfectly transferred from one silo (and technology platform) to another, and quality of the overall effort suffers.
A new paradigm shift can transform outsourced clinical research and give rise to a new kind of contract research organization. The digital clinical research organization uses technology-optimized processes to improve trial performance, visibility, and coordination among all stakeholders. Clinical research and operations software integrates functions such as site selection and management, patient recruitment, project management, monitoring, data management, product safety, and biostatistics onto one platform.
The purpose of clinical data in a clinical trial is two-fold. First, data is used for the evaluation of the safety, tolerability, and efficacy of a drug, device, or biologic. Second, clinical trial data must provide for the accurate re-creation of events that took place during the trial. Because accurate and timely data are the foundation of any clinical study, the methodology used for data collection and management is of the utmost importance.
Many clinical research organizations still rely on methods and processes that originated in a paper-based research system with obvious challenges when those processes are forced onto a digital research system. Aside from the safety implications, data silos in a research study make cross-talk among functions difficult and integration among applications expensive.
The rise of the digital CRO
Through the use of technology, the digital CRO eliminates traditional barriers in the way clinical data is collected and stored by integrating all clinical research and operations software into one platform with roles and permissions-based access for all stakeholders. Instead of layering multiple technology-based tools such as electronic data capture (EDC) and clinical trial management programs onto existing methods, this approach is streamlining outsourced clinical research.
Combining integration and transparency of clinical research processes and clinical trial metadata fosters an unprecedented level of information sharing and analysis for better decision-making and improved efficiency to conduct a frictionless clinical trial. Although the current shift occurring in clinical research is fueled by technology, the people behind the software are the lifeblood of the transformation. The digital CRO is guided by the philosophy that technology is not an add-on to clinical trial processes; it is the backbone.
While technology alone can’t accomplish anything, when matched with the right vision, people and processes, technology can significantly enhance the efficiency, cost-effectiveness and safety of running a clinical trial.
Because every stakeholder involved in a digital CRO project works around the same hub, uses the same tools, and has instant access to the same information, those team members who are devoted primarily to monitoring, status tracking, and status reporting can focus their time on making strategic contributions through trouble-shooting, streamlining, and decision-making. The ability to strategize during a trial, rather than just managing the process—is a new concept in clinical research.
Because the electronic clinical systems of a digital CRO enable real-time trial enrollment visibility and confer the ability to identify and resolve data discrepancies remotely, the need for site visits is reduced. Clinical research associates (CRAs) on a technology-amplified study do not have to travel as much as they did in the traditional model. By employing a just-in-time monitoring approach (enabled by the digital CRO model), CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event or protocol deviation.
The digital CRO model deploys CRAs more efficiently than the traditional model, facilitates identification of issues or problems, and enables earlier corrective actions, thereby reducing costs and enhancing study quality. Continuous remote monitoring of trial data and site performance via technology also helps to make visits more efficient and purposeful. Instead of having to spend days at a site reviewing vast amounts of information, a CRA can remotely identify issues that need to be addressed during the on-site visit.
Technology-enabled processes obviate the need for long meetings devoted solely to ensuring that all project stakeholders are abreast of the most current study status and issues. Likewise, rigid definition of functional areas within the project team is not required. The project team becomes more efficient because everyone is working with the same information.
All of the above-mentioned gains in efficiencies are associated with significant financial cost savings. In a current Phase 2 trial in which a sponsor used technology-amplified systems and processes, the sponsor estimates a 30% savings in the cost of the trial. This cost savings equates to more than a million dollars in operational costs through the simple process of deploying resources more efficiently.
ConclusionIn conclusion, digital CRO methods address the challenges highlighted by the FDA that are palpable to any stakeholder involved in product development. The adoption of digital CRO methods have brought about a shift to a new clinical research paradigm. Integration, collaboration, and transparency have helped to foster information sharing, enable efficient information analysis for better decision-making, and provide the environment for conduct of a frictionless clinical trial. This methodology, applied effectively on a widespread basis, is transforming the process, quality, cost, and outcomes of clinical research for the better.
Reference
1. Challenges and Opportunities Report - March 2004. U.S. Food and Drug Administration. Available at http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Accessed on August 24, 2010.
A new paradigm shift can transform outsourced clinical research and give rise to a new kind of contract research organization. The digital clinical research organization uses technology-optimized processes to improve trial performance, visibility, and coordination among all stakeholders. Clinical research and operations software integrates functions such as site selection and management, patient recruitment, project management, monitoring, data management, product safety, and biostatistics onto one platform.
The purpose of clinical data in a clinical trial is two-fold. First, data is used for the evaluation of the safety, tolerability, and efficacy of a drug, device, or biologic. Second, clinical trial data must provide for the accurate re-creation of events that took place during the trial. Because accurate and timely data are the foundation of any clinical study, the methodology used for data collection and management is of the utmost importance.
Many clinical research organizations still rely on methods and processes that originated in a paper-based research system with obvious challenges when those processes are forced onto a digital research system. Aside from the safety implications, data silos in a research study make cross-talk among functions difficult and integration among applications expensive.
The rise of the digital CRO
Through the use of technology, the digital CRO eliminates traditional barriers in the way clinical data is collected and stored by integrating all clinical research and operations software into one platform with roles and permissions-based access for all stakeholders. Instead of layering multiple technology-based tools such as electronic data capture (EDC) and clinical trial management programs onto existing methods, this approach is streamlining outsourced clinical research.
Combining integration and transparency of clinical research processes and clinical trial metadata fosters an unprecedented level of information sharing and analysis for better decision-making and improved efficiency to conduct a frictionless clinical trial. Although the current shift occurring in clinical research is fueled by technology, the people behind the software are the lifeblood of the transformation. The digital CRO is guided by the philosophy that technology is not an add-on to clinical trial processes; it is the backbone.
While technology alone can’t accomplish anything, when matched with the right vision, people and processes, technology can significantly enhance the efficiency, cost-effectiveness and safety of running a clinical trial.
Because every stakeholder involved in a digital CRO project works around the same hub, uses the same tools, and has instant access to the same information, those team members who are devoted primarily to monitoring, status tracking, and status reporting can focus their time on making strategic contributions through trouble-shooting, streamlining, and decision-making. The ability to strategize during a trial, rather than just managing the process—is a new concept in clinical research.
Because the electronic clinical systems of a digital CRO enable real-time trial enrollment visibility and confer the ability to identify and resolve data discrepancies remotely, the need for site visits is reduced. Clinical research associates (CRAs) on a technology-amplified study do not have to travel as much as they did in the traditional model. By employing a just-in-time monitoring approach (enabled by the digital CRO model), CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event or protocol deviation.
The digital CRO model deploys CRAs more efficiently than the traditional model, facilitates identification of issues or problems, and enables earlier corrective actions, thereby reducing costs and enhancing study quality. Continuous remote monitoring of trial data and site performance via technology also helps to make visits more efficient and purposeful. Instead of having to spend days at a site reviewing vast amounts of information, a CRA can remotely identify issues that need to be addressed during the on-site visit.
Technology-enabled processes obviate the need for long meetings devoted solely to ensuring that all project stakeholders are abreast of the most current study status and issues. Likewise, rigid definition of functional areas within the project team is not required. The project team becomes more efficient because everyone is working with the same information.
All of the above-mentioned gains in efficiencies are associated with significant financial cost savings. In a current Phase 2 trial in which a sponsor used technology-amplified systems and processes, the sponsor estimates a 30% savings in the cost of the trial. This cost savings equates to more than a million dollars in operational costs through the simple process of deploying resources more efficiently.
ConclusionIn conclusion, digital CRO methods address the challenges highlighted by the FDA that are palpable to any stakeholder involved in product development. The adoption of digital CRO methods have brought about a shift to a new clinical research paradigm. Integration, collaboration, and transparency have helped to foster information sharing, enable efficient information analysis for better decision-making, and provide the environment for conduct of a frictionless clinical trial. This methodology, applied effectively on a widespread basis, is transforming the process, quality, cost, and outcomes of clinical research for the better.
Reference
1. Challenges and Opportunities Report - March 2004. U.S. Food and Drug Administration. Available at http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Accessed on August 24, 2010.
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