Project Management Support for Clinical Trials Policies at NIH
National Institutes of Health/Office of Extramural Research
When the 21st Century Cures Act (Pub. L. 114-255) required changes to NIH’s clinical trials policies, NIH’s Office of Extramural Research (OER) came to Ripple Effect for support. From 2016-2019, Ripple Effect supported OER in implementing evolving policies to improve transparency and effectiveness of NIH-funded clinical trials. When large government agencies change policies, they must consider the impact on a significant number of downstream factors. OER needed support in planning and managing this large-scale policy implementation, from process and system improvements to stakeholder education and engagement, project and timeline management, decision tracking, coordination, and communication.
Ripple Effect provided a strategic solution for NIH using our unique expertise in NIH grants, clinical trials, policy implementation, and communications. Stakeholder engagement is at the core of Ripple Effect’s policy work, which allowed OER leadership to rely on our team to manage various stakeholders by bringing them together and making sure their goals and needs were considered. We developed and maintained an overarching timeline for implementation of the clinical trials policy changes. We provided meeting management support for nine work groups by developing agendas, facilitating and leading meetings, taking notes, and tracking and following up on all action items. Ripple Effect constantly ensured emerging issues were addressed by bringing in the right individuals and helping to develop solutions. We also facilitated communications between all stakeholders, including staff across NIH Institutes and Centers, the external grants community, and other federal partners. Working with our Communications & Outreach division, Ripple Effect developed a wide range of communications resources and materials for these audiences.
Ripple Effect’s expertise in policy implementation, project management, and stakeholder engagement allowed NIH leadership to focus on critical decision-making while we ensured that all processes moved forward quickly and managed the administrative challenges of this large-scale policy change effort. Our expert support staff provided consistency across all working groups and were able to make crucial connections, track small details that could have otherwise been missed, reduce risks, and maintain momentum throughout the effort. We reduced burden for our clients and increased efficiencies for OER, which has allowed NIH to continue serving as a responsible steward of clinical trials.