Clinical Trial Optimization

How can organizations best use data to tier sites into groups to support “fit for purpose” risk monitoring? That’s one of the key issues explored during Linda Sullivan’s interview with two CTO guests: Tammy Finnigan, Chief Operating Officer and Elizabeth Robertson RBM operations consultant at Triumph Research Intelligence. Some sponsors are still running traditional monitoring models while they begin developing “fit for purpose” monitoring – an approach that deploys monitoring resources to the sites based on their risk levels, according to the two guests. Grouping sites into risk categories at the beginning of a study enables you to assign more experienced monitors with the sites most likely to need monitoring oversight. Example of site data being examined under the “fit for purpose” model include historical data, such as recruitment and retention, consent, inclusion criteria, and missing data. There are human aspects such as site staff changes that should be included in this evaluation as well, the guests note. For more on this topic, check out MCC’s website,  https://metricschampion.org. While you’re there, check out the upcoming MCC Virtual Summit, at which these two guests will lead a mini-workshop about this topic, www.mcc-summit.com

Is there a common set of key risk indicators (KRIs) the clinical trials industry is monitoring to achieve world-class Risk-Based Quality Management (RBQM)? That’s one of the key issues explored during Linda Sullivan’s interview with two returning CTO guests: Artem Andrianov, CEO of Cyntegrity and Johann Proeve, Chief Scientific Officer at Cyntegrity. Andrianov and Proeve note that they do see a set of “golden” KRIs – a subset of KRIs that many of their customers are monitoring with their RBQM system. When asked by Sullivan, Executive Director of WCG’s Metric Champion Consortium, about the impact of COVID-19, both guests say that there has been huge demand for implementation and training of their RBQM platform. They specifically advise clients to begin with pilot programs when implementing RBQM. A successful strategy for illustrating the value of using a RBQM system is to conduct a retrospective analysis of a completed study to determine how early emerging issues could have been identified compared to when (or if) the issues were identified using traditional monitoring approaches. The bottom line, according to the Cyntegrity officials: RBQM is a platform that enables sponsors to identify data or process problems early on, track them proactively and avoid late surprises. And, yes, they add, it’s vital that the persons reviewing the RBQM data are capable of interpreting that data and are able to implement appropriate remedial measures. For more on this topic, check out the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit, www.mcc-summit.com

Centralized monitoring clinical trial programs can catch outlying data points in almost real time and quickly notify the clinical trial study team. That’s one of the key takeaways from Crupa Kurien’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Kurien is the central monitoring manager in the RBQM program at Pfizer, who currently manages and provides oversight for the company’s COVID-19 portfolio. For the most part, Kurien says, Pfizer’s central monitors disseminate data analysis internally.  In addition, she notes, it is important that the signals from the central monitoring platform or dashboard are fine-tuned and broadly understand to a wide audience to make optimal use of the data analytics. Pfizer’s central monitoring program runs two basic types of analyses: key-risk indicator analysis and data quality assessment, Kurien says. Central monitoring specialists ae excellent critical thinkers, she notes, trained to question best practices and communicate effectively with other team members and corporate staffers.  The pandemic accelerated the deployment of central monitoring at Pfizer, she notes, ensuring that any risks were mitigated in as close to real time as possible. Effective central monitors specialist listen to study teams, understand their protocols and work very quickly to prioritize any flagging issues. For more on this topic, check out the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit,, www.mcc-summit.com

Sponsors should approach Risk-Based Quality Management (RBQM) implementation focusing on supporting some important critical factors, including company culture, trial design, trial operations, as well as continuous improvement. That’s one of the key takeaways from Sam Sather’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Sather co-founded Clinical Pathways, a North Carolina-based consulting firm and is the company’s Vice President who leads quality management consulting services. RBQM is dynamic and should be embedded in all aspects of a stakeholder’s operations and decision-making, notes Sather. RBQM is not an optional activity or intermittent, she explains, and needs cross-functional representation. Finally, Sullivan and Sather take a deep dive into the differences between how small and large sponsors implement RBQM which varies based on how companies view risk-taking, what is at stake for success, access to data, outsourcing strategies, and regulatory inspection experience. Whatever you do, Sullivan and Sather conclude, document it. For more on this topic, check out the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit, www.mcc-summit.com

With the anticipated adoption of ICH-E8-R1 this summer, there’s going to be even more attention on patient voice and engagement and critical-to-quality factors. MCC’s Quality by Design (QbD) - Risk Based Quality Management (RBQM) – Quality Improvement community of practice group is has already developed practical tools to help optimize quality by design. These are some of the key topics discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates the MCC QbD-RBQM- Quality Improvement Group.  The Cost of Poor Quality Estimator Tool enable users to estimate the financial impact of quality problems that arise during study conduct, notes Dorricott.  Other tools developed by MCC members in the quality by design area, note Sullivan and Dorricott, include the protocol development quality scoring tool and the protocol operational complexity scoring tool, which support the process of identifying potential quality problems during protocol development. Both  tools include consideration of the patient perspective, and the protocol operational complexity scoring tool calculates a patient burden measurement as well, adds Sullivan. MCC members will be reviewing the tools over the next few months to determine what updates will be needed to align with ICH-E8-R1, she notes. Finally, Sullivan says, MCC will be launching a Patient Diversity community of practice group this month to provide a place for members to consider how to assess the impact of patient engagement programs and to ensure that the “voice of the patient” is incorporated into QbD tool updates. For more on this topic, check out the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit,, www.mcc-summit.com

How can you best engage patients in the design and execution of your clinical trials?  That’s one of the important topic discussed in Lori Abrams’s  interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Abrams is the Executive Director of Patient Advocacy and Diversity at WCG and the former Director of Diversity & Patient Engagement at Bristol-Myers Squibb (BMS).  It’s incredibly important to involve minority populations in your clinical trials to deal with health disparities in the United States, notes Abrams.  That effort brings awareness, voice, and diversity to your clinical trials, she explains. By involving the voice of patients and caregivers in your clinical trials, Abrams adds, it can help you identify new investigators and overcome obstacles to recruitment in the clinical trial process.  When you work with advocacy groups on engagement and diversity issues, make sure that the relationship is not transactional and you give them credit for the success of the project, she asserts. At BMS, Abrams started regular educational seminars that involved patients and caregiver voices, and diversity and engagement became GDO’s portion of company’s goals.  FDA recently asked a company to submit a diversity plan for a Phase III study, she notes, which illustrates that we are at a “crossroads” in the clinical trials diversity effort, she notes. For more on this topic and the upcoming launch of MCC”s Patient Diversity of Practice Group, check out the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit,, www.mcc-summit.com

MCC launched its groundbreaking monitoring process metrics working group last year with the purpose of developing new metrics that take into account changes in the clinical monitoring process, including risk-based assessment and centralized monitoring integration. That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC).  The collaborative working group started with the challenging process of developing a process map that depicts the new monitoring approach that integrates centralized monitoring with remote and onsite monitoring, Dorricott notes. The group has been utilizing the MCC metric development framework described in a previous podcast to identify critical success factors, key performance questions, and ultimately metrics that organizations can utilize to oversee and management new monitoring models. The group anticipates the first installment of metrics to be published by the end of May. Sullivan notes that MCC has knowledge portals, including those on monitoring, that members can utilize to optimize their clinical trials. For more on this topic, check out the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit,, www.mcc-summit.com

MCC has developed a valuable risk assessment and mitigation management tool that organizations can use as the basis for implementing the risk-based quality management process outlined in ICH E6 (R2), section 5.0. That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC).  Dorricott facilitates MCC’s QbD-RBQM-Quality Improvement Community of Practice Group. Dorricott describes how MCC members have worked collaboratively over the last five years to develop a Risk Assessment and Mitigation Management Tool (RAMMT) that moves beyond the RACT tool that was developed by another industry group. The initial drive was from members wanting MCC metrics to be aligned with individual risks to assist with risk scoring. Sullivan points out that when ICH E6 (R2) was released, the group conducted a gap analysis to determine whether the tool fully supported the approach outlined in the guidance. The tool was updated to support a new approach that includes identifying critical processes and data and utilizing MCC process maps and key risk indicator metrics already developed by MCC metric development groups. Sullivan and Dorricott note that it’s important for risk indicators to detect risk and emerging issues as early as possible to reduce, and maybe eliminate, the negative impacts. However, Sullivan and Dorricott add, when you’re scoring your risks, you should score the ‘as-is’ situation and document any additional mitigations such as improved detection, or additional training and guidance. Otherwise, the mitigations may not actually be implemented and the risk will be higher than anticipated. Indeed, Sullivan says, documentation is key to risk assessments now being required by regulators. This topic is covered in a White Paper on the MCC website,  https://metricschampion.org. And while you’re there, check out the upcoming MCC Virtual Summit.

MCC metric toolkits include comprehensive sets of time, cost, and quality metrics defined at portfolio, study, and site levels – but how do organizations decide which metrics to include in their metric reports? That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC).  Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates many MCC metric development work groups. Dorricott describes several metric selection tool options included in MCC metric toolkits — each designed to help organizations select the right metrics for their programs. Some organizations opt to start off with metrics that are designated as “basic” metrics and add other metrics as needed. Alternatively, organizations can select metrics that answer important key performance questions and/or help to manage common process issues. Sullivan discusses an often vexing question: If a metric is always “green,” does it still need to be deployed? Answer:  It depends — because the measurements of time, cost, and quality are not always static. What you decide to measure can say a lot about your organization – it sends a signal to your employees and vendors about what is important, she points out. Be sure to consider the unintended consequences of removing a metric – does it mean that achieving a high level of performance is no longer important?

How do MCC metric development work groups determine what metrics to include in a metric toolkit? That’s one of the important topics discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC).  Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates many MCC metric development work groups. Dorricott describes the MCC Metric Development Framework – a multi-step, structured approach MCC work groups use to develop metric toolkits. Rather than starting with metric definitions – which may end up focusing on metrics that are easy to measure rather than the right metrics, this framework focuses on the process and measuring what matters.  The starting point for this approach is to have the group to develop a process map, which helps define a glossary of terms and the aim of the process, according to Dorricott. While the high-level process map may not look exactly like the process at any given organization, it becomes the Rosetta Stone, enabling conversations with the multi-stakeholder members of the work group, adds Sullivan. Once the process map is developed, the work group collaboratively defines critical success factors – the desired outcomes of the process. Then key performance questions are defined. These are the questions that, when answered, help you determine whether a critical success factor is being achieved. Finally, the group defines metrics that provide information to answer each key performance question. There’s a tremendous amount of detail in the metric sets of the toolkit to help provide context and for implementation, which often surprises stakeholders, note Dorricott and Sullivan. In addition, they explain, toolkits contain target goals and companion metrics that can be used for further analysis, with the eye on the prize of finding root causes and improving overall clinical trials. Finally, Sullivan notes, it’s important that metric results are displayed in the most informative and user-friendly way as possible.