By: Kenric England | January 12, 2017
The importance of stage gate reviews to good clinical research project management.
Any project or program manager worth their salt knows the value of formal stage gate reviews to the success of a project.
Stage gate reviews are a cornerstone of good project management, and improve project planning, reduce number of projects in escalation and deliver projects with excellent results through a set of structured reviews of specific project elements (as established by Gate Entrance Criteria) at various points in the project lifecycle.
This project management best practice is relevant whether a team is designing a new product, building an app, or developing a blockbuster drug that will improve the lives of millions of patients around the world. Indeed, we believe it is most critical in the later environment, where every decision can directly impact the time, cost and outcomes of clinical research projects.
At QuintilesIMS we have implemented a formalized, holistic and integrated Stage Gate Review approach to give our teams all the resources and guidance they need to deliver a successful project in service of our sponsors, sites and patients.
The stage gate review process seeks to optimize engagement of key stakeholder at key points in the project lifecycle so as to improve:
For example, as a clinical trial moves into recruiting, sponsors often consider protocol amendments and other changes based on early feedback. A stage gate review provides an opportunity for everyone to revisit the research strategy, and evaluate how any changes will impact the trial schedule, delivery, and patient experience. Such conversations help to break-down silos between decision makers so that small changes at one point in the trial don’t negatively impact other areas.
This is especially valuable in the clinical research setting because there are so many unknowns, both with the research itself and externally, in the pharmaceutical marketplace. Consider oncology research. Over the past few years we have seen incredible advances in immunotherapies, and every new discovery has the potential to impact ongoing trials and the current standards of care. A stage gate review process in this type of research makes sure assumptions about a potential treatment’s commercial viability continue to be relevant, and give stakeholders a chance to evaluate their recruiting strategies or the need to amend protocols.
Similarly, early results in such trials might highlight opportunities to add new arms as investigators garner insights about how an agent works. A stage gate review process means such considerations are considered at the right point in the trial, with all key stakeholders at the table.
By establishing a formal review process, we don’t wait for events to occur before having these conversations. It becomes an inherent part of the project culture, leading to a more transparent environment where project teams and stakeholders have the right conversations at the right times, so that they can remediate roadblocks, challenge assumptions, and proactively identify and mitigate risks before they escalate. All of these benefits translate to improved predictability, fewer delays, and a better working environment for everyone involved.
At the end of the day, such formal project management best practices are what our clients expect from a world-class clinical research partner. It reinforces the rigor and structure of our approach to research, and gives them the confidence that we are doing everything we can to increase their likelihood for success.