Category 1: Management of Technology Solutions
Category 2: Integrating Change Management
Category 3: Managing Guidance and Requirements from Health Authorities
Category 4: Identifying the Right Metrics
GLOSSARY: Key Terms Defined
Category 2: Integrating Change Management
Change management is the practice of aligning values, culture, people and behaviors to new modes of operation that will reshape an organization. A practice that’s applied to corporations across all industries and disciplines, successfully integrating change management into RBM adoption will be critical.
Addressing challenges and deviations from the outset of a RBM plan is important to efficiently manage roles and expectations throughout a trial’s lifecycle. This includes educating and involving new and potential adopters about the nuances of RBM, debunking myths surrounding RBM, and creating awareness campaigns and comprehensive training tailored to key stakeholders. Essential to efficient adoption of RBM is a shared understanding of terminology, scope of tasks, and roles and responsibilities across the entire stakeholder ecosystem.1
Let’s explore what change management could look like for key trial players.
A common concern among sponsor company teams has been fear that they’ll miss critical errors when they integrate RBM into their risk assessment. Some are worried about potential punitive measures if there are audit findings following implementation. These concerns are largely due to a lack of understanding of RBM – but with more education and successful case studies on the way, progress should be made in coming years.
The industry is already seeing – and will likely see more – sponsor companies and others that have experienced success with RBM publicly advocating for it. Increasing external conversation around how RBM is an asset that helps detect emerging risks and issues will help create deeper understanding of RBM’s impact on trial success.
More companies likely will provide comprehensive and cross-functional training to study teams, support functions, and peripheral groups like compliance and auditing, to ensure teams are understanding RBM concepts and properly applying new skill sets. Change management training should also emphasize that RBM does not start at “first patient in” but is rather enabled through a holistic Quality by Design approach that plans ahead for effective cross-functional risk mitigation activities, and addresses and adjusts risk activities throughout the trial lifecycle. Educating on this is key to reducing anxiety around missing errors that could hinder a trial.
One area of particular interest for companies who have adopted RBM measures has been the potential to establish a designated leader for Centralized monitoring. Thus far, some companies have taken various approaches to organizational design to implement this function – with many companies carving out a specific and new role to do so. In the near future, there may be an industry movement towards a single process / function to assess risk, evaluate Risk Indicators, draw conclusions and direct resulting activity, which could achieve a more efficient implementation.
Teams implementing RBM should plan to retain learnings and best practices so they can be applied for learning, future plan enhancements and re-application. It’s imperative that companies build off of the knowledge they are gaining around RBM now to impact future use.
Getting investigative sites on board with RBM is critical: the site is key to the trial’s success and thus, key to a successful implementation. As with sponsor companies, raising sites’ awareness and demystifying certain unknowns associated with RBM can potentially help implementation. Tactics include trainings and other educational measures. We anticipate that open and strong communication between site staff and sponsors can also help with effective site adoption. Sponsors also need to be prepared to adjust their methods to meaningfully address concerns raised by sites.