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International Clinical Trials

Metrics System

CROs, along with pharmaceutical and biotech companies, will be able to speak the same language in reference to the metrics they want to capture. They will have a standard definition, a formula for understanding the data, and key targets for the data. Additionally, data will be reported in a similar manner across CROs and sponsor companies. More importantly, benchmarks will be established that will enable sponsors to compare their performance data against that of the rest of the industry. This is where the real benefit to sponsors will come into play. This standardisation will allow CROs as well as pharmaceutical and biotech companies an opportunity to work together to identify process steps that need improvement with the intention of streamlining the clinical trial process.

There is, however, much work that remains to be done on this important industry initiative. With the establishment of v1.0 of the Clinical Trial Metrics, a new work group has been established to aid members in the implementation of the metrics and provide a forum for those companies to share their progress and raise issues that they may have. In addition, another work group has been established that looks at protocol quality and site assessment score user tools. If adopted, these tools will have a real impact on the industry and will be truly innovative metrics, providing some very keen insight into two important elements that historically lead to delays in clinical trials.

The site assessment score, for example, will provide insight into the identification of high-quality sites, which can have a direct impact on the likely success of meeting enrolment targets and complying with the protocol. This will be one more critical tool in identification of the right sites for the right study which, in turn, should increase the possibility of meeting patient enrolment expectations.

METRICS IN USE: THE CUSTOMER VIEW

Since late 2009, i3 has been using the list of MCC metrics as a starting point for discussion of relationship-level metrics internally and with its customers. This data is used to standardise the list of metrics selected as key performance indicators (KPI) across studies and across the relationship in order to track the health of key processes. In time, customers will be able to compare these metrics to standards across the industry through the MCC’s blinded database.

At i3, a set of agreed upon metrics are established by the management steering committee within the customer relationship. The metrics include ranges that represent the target (green), a cautionary range (yellow), and when the metric is considered off-target (red). For example, the metric established by the MCC for monitoring visit report compliance (that is, the percentage of monitoring visit reports submitted for review within 14 calendar days of site visit) will include a target of greater than or equal to 95 per cent (green) and a cautionary level of between 80 and 95 per cent (yellow). Anything below 80 per cent is considered off-target (red), and action is necessary to improve the process and get it back on track. Timely monitoring visit reports are important to gain insight in the quality of the data obtained from the site, patient safety, and adherence to regulatory guidelines.

A process is established to review metrics with the customer across the relationship on a regular basis (for example, quarterly) which, in turn, will drive action. If a particular metric is not where it needs to be, it is the responsibility of a joint metrics sub-committee under direction of the steering committee to understand why it is off track. This crossfunctional team from both i3 and the customer conducts an analysis session to determine the genesis of the issue. Once established, the team identifies solutions and implementation strategies. The joint metrics subcommittee also monitors progress and determines if there are any additional solutions needed. As an ongoing exercise, the list of metrics is reviewed on a quarterly basis to ensure the ‘right’ metrics are represented. Small tweaks may be made to the metrics, or the definitions of the metrics, to better align with the objectives of the customer.

This process, combined with the use of MCC metrics, has been well received by customers; data are used to more objectively identify root causes and potential solutions.

METRICS IN USE: THE CRO VIEW

i3 also has established its own internal Metrics Strategy Team with cross-functional participation across the organisation. A Quality Dashboard has been in place for a number of years, but the  addition of the MCC metrics has provided new industry perspectives as the organisation has recalibrated the dashboard to account for the MCC measures and the ‘health’ of the clinical trial process within the company.

The initial focus of the Metrics Strategy Team has been on a limited number of metrics which measure key elements of a study phase. For example, metrics that relate to study start-up (percentage of planned sites activated), patient enrolment (ability to meet/exceed patient enrolment expectations), clinical monitoring (compliance with monitoring visit report completion), data management (number of calendar days from last patient, last visit until database is locked by data management) and quality assurance (average number of major/critical audit findings per final audit report) have been selected. Each potential metric was ranked by value to the company as well as ease of collection. The final list was presented and reviewed with the leadership team before implementation.

It is essential that the metrics are actionable. Data owners and process owners are assigned to each metric. The data owner is responsible for collecting the data for the metric and adding it to the dashboard. The process owner is responsible for reviewing the metrics, investigating why a particular metric is off-target, as well as identifying and implementing action plans to get it back on target.



FOOD FOR THOUGHT

The MCC should make a significant impact on the industry by establishing a set of standard metrics with universal definitions, formulas and targets to improve processes and increase the probability of more efficient clinical trials.

As part of the MCC Steering Committee, i3 has helped identify a number of key areas within the MCC list that do not include applicable metrics, and suggested that the MCC focus attention on these in the future. Three important aspects of the clinical trial process particularly relating to regulatory adherence include the trial master file (TMF), pharmacovigilance and training compliance.


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Nick Jackson is Associate Director, Process Management and Improvement, responsible for leading quality improvement initiatives across i3. Nick has been actively involved in multiple strategic relationships with sponsors, participating as a member of management steering committees to assist with metrics selection/review, lessons learned reviews and leading quality improvement teams. Through i3’s sponsorship of the Metrics Champion Consortium, Nick is able to bring an industry-leading approach to metric selection and use. Nick also has worked directly with customers to lead various improvement projects, such as those improving the site initiation process. Nick has a Black Belt in Six Sigma from UnitedHealth Group and received his BS from the University of Scranton. Email: emailto:specialists@i3global.com
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