Clinipace

[This post is the second in a three-part series about the transformations that are occurring throughout the clinical research industry and Clinipace Worldwide's effort to bring more efficiency and transparency to the process.]

The new clinical research paradigm is characterized by a unified technology that enables integration, collaboration, and transparency across all stakeholders: integration and collaboration among functions and roles across the spectrum of clinical trials components (e.g., Site Selection/Management, Patient Recruitment, Project Management, Monitoring, Data Management, Biostatistics) and project- and stakeholder-wide transparency of both clinical research processes and clinical trial metadata.

In the new clinical research 3.0 paradigm, integration and transparency foster an unprecedented level of information sharing, enable efficient information analysis for better decision-making, and provide the environment for conduct of a frictionless clinical trial.

While similar in many ways to a traditional Contract Research Organization, the dCRO is built around a vision of clinical research 3.0, which improves upon the traditional Contract Research Organization model by using technology-amplified processes to improve trial performance, visibility, and coordination among all stakeholders. Clinical research software integrates the spectrum of clinical trials functions in one platform accessible to all stakeholders; eliminating silos, which are often times, conceptualized and operate independently, each with its unique budget, systems, and software.

In contrast to the traditional CRO, which views technology as an add-on to a personnel-based system, the dCRO begins with technology as a platform and adds to it the minimum number of people to do an effective job. With judiciously employed technology, fewer people and resources are needed to do a job. In the dCRO, technology carries some of the work burden that would typically be carried by people, so the people component is smaller and less expensive.

Technology Is the Backbone of the Transformation, but People Are Its Heart

Although the current transformation occurring in clinical research (led by Clinipace Worldwide) is fueled by technology, technology is not its heart. Rather, people who share a vision of technology as a tool that can bring both unsurpassed efficiency to the process of running a clinical trial and unsurpassed quality to clinical trial outcomes are the heart of this research transformation.   A shared passion for using technology for the success of the project underpins the culture of a dCRO.

To those people working in the digital Clinical Research Organization, technology is not an add-on to clinical trial processes; it is the backbone.  The dCRO is guided by the philosophy that using technology to drive the clinical research process optimizes outcomes. The soundness of this tenet is intuitively obvious: in the process- and regulation-driven setting of a clinical trial, the use of technology should make the processes more organized, efficient, and transparent.

While clinical research cannot be completely automated, technology can bring visibility and control to a level not previously possible. In the dCRO model, technology facilitates the optimization of tailored resources so that just the right number of individuals—that is, the minimally effective number of individuals—becomes engaged in clinical trial management. In contrast, the traditional approach to clinical trials centers on providing (selling) people by the hour and each stakeholder adds his or her specialized technology. This approach increases costs, reduces collaboration, and makes processes more complicated.

The dCRO approach of using technology to optimize tailored clinical trial resources is changing the face of clinical research. Project stakeholders’ adoption of technology is transforming the way teams work individually and collectively toward common goals. As a result of these changes, clinical trials have better quality control and are run with greater efficiency and at reduced cost.

In part three, we’ll discuss the how the entire ecosystem will benefit from this transformation.

CROs and Sponsors alike say they see trial project teams making the same mistakes over and over. Missteps like: teams not following standard project management processes, not staffing the clinical trial appropriately, not assessing the risks (and managing them) that could imperil their projects, and the the list goes on.

A few weeks back Clinipace hosted a educational webcast to assist project managers identify, measure, and fix the top challenges faced by clinical trial teams. Any of these impacting your trial?

#1: First Subject, First Visit Delayed

What to look for…

• CRF, database, and planning activities are driven off of a synopsis or draft protocol
• Protocol not approved in first cycle of IRB review
• Poor site compliance with regulatory document submissions
• Poor Investigators’ Meeting attendance

How to measure…

• Close contact with central IRB
• % of PI’s that attend the IM

How to fix…

• Gather site feedback on the draft protocol
• Target  key central IRB sites during start-up

#2: Enrollment Rate Does Not Meet Expectations

What to look for…

• Target enrollment rate does not match historic rates
• Fewer  sites than expected show interest in participating in the study
• Study coordinators raise questions or concerns about the inclusion/exclusion criteria or schedule of assessments
• High screen-failure rate observed
• Poor awareness of the treatment standard-of-care and /or competitive landscape (global and local)

How to measure…

• Use technology to measure and monitor screening, enrollment, and screen failure rates
• Reassess enrollment expectations at the PSV and IM

How to fix…

• Build enthusiasm for the scientific aims of the study
• Focus on high-performing sites
• Facilitate learning and information-sharing across sites
• Identify and activate back-up sites early

#3: Trial Cost Overruns

What to look for…

• Breakdown of the Sponsor-CRO relationship
• Study monitoring is poorly aligned with site enrollment
• Protocol amendments required
• Pass-through costs are greater than expected
• Enrollment lags expectations

How to measure…

• Availability of PM or other key team members
• On-line monitoring visit calendar
• Analyze spending rates on invoices

How to fix…

• Start with a clear and comprehensive Communication and Risk management plan
• Use remote and just-in-time monitoring
• Validate site cost expectations before setting trial budget

#4: Project Team Turnover

What to look for…

• Historic turnover rate
• Historical delays or challenges with the program
• Rising stars
• Attitude and enthusiasm of the project team
• Availability of project team members

How to measure…

• Ask about turnover rate and transition plans
• Pay attention to attitude and availability

How to fix…

• Start with a clearly defined transition plan
• Follow the Communication and Issue Escalation Plan
• Manage quality of life challenges

#5: Data Quality Challenges

What to look for…

• Sites express concerns or have many questions about the protocol or schedule of assessments
• Poor alignment of monitoring visits with site enrollment
• Inexperienced sites or monitors
• High subject drop-out rate
• Lag time for data entry at sites
• High query rate (in general or around specific CRF fields)

How to measure…

• Use technology to track questions
• Use technology to measure data collection and drop-out rates
• Monitor query trends

How to fix…

• Maintain and FAQ starting from the PSV and IM through the study
• Use experienced sites and monitors
• Validate the protocol with the CRO and sites