Getting Ahead of ICH E6 (R2) with Dashboards
May 14th, 2018
Not all roads in clinical trials lead to success, particularly when you are facing growing complexity, shrinking timelines and new regulatory changes. It’s been advocated that adopting technology will solve a number of issues related to these challenges, which is true—although there are some critical Best Practices that will help smooth the way and reduce the amount of effort to achieve the desired results.
In a recent webinar, Comprehend introduced advice on how to empower various levels of stakeholders in Clinical Development. The goals remain the same, e.g. meeting timelines, investigating and resolving issues, evaluating performance and status, and assuring patient safety. However, adopting the use of technology that provides role-based dashboards of clinical insights can significantly impact the success rate and timeliness of the study conduct phase.
According to a recent survey by Tufts Center for the Study of Drug Development (CSDD) of Clinical Development senior staff, vendor oversight programs are top of mind due to regulatory changes, and this includes addressing risk, vendor collaboration, compliance, and shared metrics. However, when asked how study information is shared between Sponsors and vendor partners, it was noted that the majority of Sponsors claimed their vendors still rely on communicating study reports through email and phone. Some of the most important challenges to Sponsors continue to be lack of shared actionable metrics, with no clear direction to be taken, which can be directly related to manual, limited reporting practices.
Key Focus Areas to Address Compliance
The webinar outlined four main areas of consideration that should help Sponsors narrow their focus in addressing compliance. These areas included:
- Delivering the right information at the right time
- Ensuring completeness of information
- Providing actionable information
- Directing joint teams on where and how to resolve issues
Each of these areas are supported by technology but where are Sponsors having the most success? The webinar presented a case study of a mid-sized pharmaceutical company as an example of how to effectively apply technology to address these areas.
Engaging Multiple CROs across Studies and Systems
When working in a complex environment involving both inhouse and external outsourced teams, Sponsors are challenged by juggling timelines with the coordination of work required. In the case of the mid-sized pharmaceutical, their VP of ClinOps was tasked with maintaining data quality, site management, subject enrollment, and team productivity, all while addressing compliance and oversight across six studies and three CROs. The key objective was to reduce the delays the Sponsor had experienced in getting their drugs to market.
Engaging the use of technology to reduce manual effort and save time was one aspect of their approach. However, they quickly realized that focus was another key, critical objective. In order for their studies to reach milestone objectives, all teams needed to work together, and concurrently, and be as efficient and effective as possible in each of their roles.
This Sponsor chose to address this objective by organizing views, or dashboards, specific to each of the team members’ roles. Using technology that provided up-to-date information in screens that automated status and performance, each team could quickly see issues and drill into the details they needed to take action. The technology also provided a collaborative messaging facility, called task management, that enabled teams to share action items and communicate steps to take, either internally or with external vendor partners.
Dashboards for Every Role
Each of the teams had different priorities, and having a role-based view of cross-portfolio, cross-study and cross-system information significantly helped them see exactly what was important to them. In the case of the executive-level teams, having color-coded indicators in a snapshot view, enabled them to quickly see portfolio status, comparisons and performance. This was critical to targeting areas that could delay studies and potentially affect investment and other financial decisions.
The senior ClinOps team members responsible for coordinating CRO agreements and tasks could easily see where issues, gaps, and delays were evident. The dashboards enabled them to better coordinate joint issues and activities, and address risk and compliance as part of the oversight plans in place.
For study managers, having a dashboard that helped speed issue resolution, and improve quality and performance, was a tremendous time-saver. As an example, they could quickly see where studies were faltering in enrollment, and drill into specific details on root-cause, just through clicking in their screens. They could compare performance across sites and CRAs, giving them immediate actionability on what to address and to whom.
And, as a CRA, having detailed information on individual sites significantly reduced time spent on manual research and investigation. This enabled CRAs to pinpoint where to spend their time, rather than to be required to visit each and every site without knowing in advance if that site had issues.
An ICH E6 (R2) Focus
In order to support the ICH guidelines, the Sponsor adopted some additional Best Practices as part of their solution. They organized a streamlined way to continuously integrate all relevant data on their studies, so that the dashboard information was the most accurate and up-to-date. They worked closely with their CRO partners to develop joint KPIs to monitor performance across their studies and portfolios. They engaged all team members in collaborative activities to find, monitor, and resolve issues in communications, escalations, and tasks. And finally, they established a fact-based method of managing risk by enabling threshold detection and alerting, along with views of improving and worsening trends.
With proactive monitoring, the executive and senior level dashboards enabled the VP of ClinOps to add more trials, without adding staff. Having visibility across their enrollment funnel and site productivity enabled them to eliminate many change order costs and speed enrollment.
The Sponsor was able to increase team productivity through the use of automated scorecards and KPIs. And finally, the Sponsor established a program that provided fact-based reporting and process to assure accurate oversight and compliance for ICH E6 (R2) objectives.
- Tufts CSDD “Oversight Effectiveness Survey 2018”