Rick Morrison, Chief Executive Officer, Comprehend01.04.16
The two highest priorities of any clinical trial are to deliver high-quality results, and deliver them on time. Yet given the lack of clarity that can plague the trial process, ClinOps teams are hard pressed to deliver either. CenterWatch, in a recent survey, found that less than 10% of all clinical trials finish on time—and 80% regularly miss milestones.
Uncertainty in trial research takes many forms. Study risk is a major challenge: enrollment delays, excessive query levels, missing data, protocol deviations and other issues often destabilize trial progress and produce speculation over results. Data quality is another cause of uncertainty, often brought about when multiple, highly-complex trials are being conducted with thousands of patients simultaneously at hundreds of global sites.
Many studies miss critical milestones due to unforeseen or undetectable problems. During patient recruitment—a stage that often generates the lowest performance scores and greatest variations—teams can overlook critical but hidden factors that cause a trial to lose momentum. Nearly 80% of clinical trials fail to meet enrollment timelines. When such delays occur, organizations risk investigator burnout, loss of interest, or even trial abandonment.
Unnoticed or unaddressed regulatory issues often create headaches as well. Regulators and patient advocacy groups are more likely than ever to scrutinize parameters such as patient sampling or protocol inclusion criteria, which increases the burden on study teams to perform exactly as specified.
CenterWatch reports that the average cost of bringing a drug to market in the U.S. is $1.3-1.7 billion, of which clinical trial costs are one of the biggest line items. With so much at stake, it’s no wonder that both Sponsors and CROs are seeking better solutions to eliminate unforeseen problems.
What’s sorely needed is greater visibility, something existing protocols and technologies have historically been unable to guarantee. For years, trials were dominated by paper. With the advent of Electronic Data Collection (EDC) and clinical trial management systems, operations personnel were able to improve data integrity and better manage workflows. Yet there has never before been a way to effectively look at all clinical trial data, across all systems—and not only at the site level, but also at the study and portfolio levels. Doing so would allow deeper issues surrounding performance to be ascertained at their earliest stages, when the impact of concerns is minimal and solutions are relatively pain-free.
The recent introduction of validated, cloud-based software solutions is finally providing a response to the visibility challenge. Built with robust data integration capabilities and powered by advanced analytics, these solutions are helping study teams hit their milestones and provide quality results faster.
One of the greatest advantages to next-generation cloud solutions is the ability to unify and normalize data from multiple and even incompatible sources. Reliable, pre-built adapters are able to connect to all of a sponsor’s data collection systems. The new generation of cloud-based solutions are designed to sit on top of existing systems, with no on-premises installation and minimal configuration required. With IT burdens minimized, cloud-based solutions require a much smaller capital investment.
Efficient data exchange and access allow users to better interrogate data and improve their outcome reporting. With the full range of data at their disposal, teams can make better-informed decisions.
Real-time access to all relevant data, supported by clear visualizations of outliers and sophisticated analytics, give clinical trial leaders a better idea where to focus their attention. Enrollment, patient compliance, site compliance and data quality are now fully visible at the portfolio, program, study and site level.
Teams can now act faster through integrated collaboration. They can improve their investigation speed, make smarter, more collaborative decisions faster, and be more coordinated in remedial actions. A variety of advanced tools go beyond email to encourage more efficient and inclusive collaboration within organizations, and/or between Sponsor and CRO.
Early notification of issues is made possible by automatic alerts that are incorporated directly into system analytics and delivered either to the desktop or to a mobile device. When an alert is sent, managers are able to determine root causes by quickly drilling down into reports.
Until now, the issue with clinical trial management hasn’t been the lack of technology, but the lack of the right technology. Automation is important, as is the ability to unify and normalize data previously residing in silos. Interactivity, collaboration and communication is essential, as is a common workflow that supports mutually-recognized goals. Lastly, timeliness is an imperative to ensure high-quality studies that are completed within budget.
Today’s cloud-based solutions put the full power of technology to work in order to instill the certainty that study leaders wish for. They are not only establishing a new era of best practices, but also revolutionizing the very nature of clinical study itself. Given the challenges, complexities, and critical importance of trials to the effectiveness of modern medicine, innovations such as these have the potential to significantly, and positively, impact the future of life science.
Rick Morrison is Chief Executive Officer of Comprehend, a provider of clinical software solutions for clinical trial management.
1 October, 2005. Hess, Jon. Web-based Patient Recruitment. Cutting Edge Information.
Uncertainty in trial research takes many forms. Study risk is a major challenge: enrollment delays, excessive query levels, missing data, protocol deviations and other issues often destabilize trial progress and produce speculation over results. Data quality is another cause of uncertainty, often brought about when multiple, highly-complex trials are being conducted with thousands of patients simultaneously at hundreds of global sites.
Many studies miss critical milestones due to unforeseen or undetectable problems. During patient recruitment—a stage that often generates the lowest performance scores and greatest variations—teams can overlook critical but hidden factors that cause a trial to lose momentum. Nearly 80% of clinical trials fail to meet enrollment timelines. When such delays occur, organizations risk investigator burnout, loss of interest, or even trial abandonment.
Unnoticed or unaddressed regulatory issues often create headaches as well. Regulators and patient advocacy groups are more likely than ever to scrutinize parameters such as patient sampling or protocol inclusion criteria, which increases the burden on study teams to perform exactly as specified.
CenterWatch reports that the average cost of bringing a drug to market in the U.S. is $1.3-1.7 billion, of which clinical trial costs are one of the biggest line items. With so much at stake, it’s no wonder that both Sponsors and CROs are seeking better solutions to eliminate unforeseen problems.
What’s sorely needed is greater visibility, something existing protocols and technologies have historically been unable to guarantee. For years, trials were dominated by paper. With the advent of Electronic Data Collection (EDC) and clinical trial management systems, operations personnel were able to improve data integrity and better manage workflows. Yet there has never before been a way to effectively look at all clinical trial data, across all systems—and not only at the site level, but also at the study and portfolio levels. Doing so would allow deeper issues surrounding performance to be ascertained at their earliest stages, when the impact of concerns is minimal and solutions are relatively pain-free.
The recent introduction of validated, cloud-based software solutions is finally providing a response to the visibility challenge. Built with robust data integration capabilities and powered by advanced analytics, these solutions are helping study teams hit their milestones and provide quality results faster.
One of the greatest advantages to next-generation cloud solutions is the ability to unify and normalize data from multiple and even incompatible sources. Reliable, pre-built adapters are able to connect to all of a sponsor’s data collection systems. The new generation of cloud-based solutions are designed to sit on top of existing systems, with no on-premises installation and minimal configuration required. With IT burdens minimized, cloud-based solutions require a much smaller capital investment.
Efficient data exchange and access allow users to better interrogate data and improve their outcome reporting. With the full range of data at their disposal, teams can make better-informed decisions.
Real-time access to all relevant data, supported by clear visualizations of outliers and sophisticated analytics, give clinical trial leaders a better idea where to focus their attention. Enrollment, patient compliance, site compliance and data quality are now fully visible at the portfolio, program, study and site level.
Teams can now act faster through integrated collaboration. They can improve their investigation speed, make smarter, more collaborative decisions faster, and be more coordinated in remedial actions. A variety of advanced tools go beyond email to encourage more efficient and inclusive collaboration within organizations, and/or between Sponsor and CRO.
Early notification of issues is made possible by automatic alerts that are incorporated directly into system analytics and delivered either to the desktop or to a mobile device. When an alert is sent, managers are able to determine root causes by quickly drilling down into reports.
Until now, the issue with clinical trial management hasn’t been the lack of technology, but the lack of the right technology. Automation is important, as is the ability to unify and normalize data previously residing in silos. Interactivity, collaboration and communication is essential, as is a common workflow that supports mutually-recognized goals. Lastly, timeliness is an imperative to ensure high-quality studies that are completed within budget.
Today’s cloud-based solutions put the full power of technology to work in order to instill the certainty that study leaders wish for. They are not only establishing a new era of best practices, but also revolutionizing the very nature of clinical study itself. Given the challenges, complexities, and critical importance of trials to the effectiveness of modern medicine, innovations such as these have the potential to significantly, and positively, impact the future of life science.
Rick Morrison is Chief Executive Officer of Comprehend, a provider of clinical software solutions for clinical trial management.
1 October, 2005. Hess, Jon. Web-based Patient Recruitment. Cutting Edge Information.