Novel Clinical Trial Designs

Expert Meetings

Harnessing data from electronic health records, claims, registries, and other sources of real-world data creates new opportunities that can transform research, drive care, and achieve a fully integrated health process. However, understanding which approach is best suited (or not) for a specific clinical research question is critical.

CTTI is here to help. We have examined the evidence, learned from experience, and gathered diverse perspectives to create pathways and tools that can help you implement the most appropriate novel approach to efficiently achieve your specific research goals.

Projects

ABDD HABP/VABP STUDIES

Learn about CTTI's prospective, multi-center, observational study of the risk factors for HABP/VABP.

ABDD PEDS TRIALS

Design pediatric antibacterial trials that ensure adequate enrollment, decrease the burden on sites and families, and increase engagement with healthcare providers.

ABDD STREAMLINING HABP/VABP TRIALS

Streamline protocol elements and data collection in HABP/VABP trials to increase enrollment, reduce trial complexity, and optimize operational efficiency.

ABDD UNMET NEED

Read about CTTI’s research findings on patient and physician perspectives and considerations as it relates to using antibacterial drugs developed through streamlined development processes.

REAL-WORLD DATA

Use RWD to evaluate trial eligibility criteria and recruit potential research participants.

MASTER PROTOCOL STUDIES

Use master protocol studies to drive medical product development.

TRIALS IN CLINICAL PRACTICE

CTTI has created much-needed recommendations and resources to help overcome the obstacles of integrating clinical trials intended for medical product review into clinical care.

REGISTRY TRIALS

Assess, develop, and evaluate registries for the support of clinical research and help meet expectations for FDA review of new products.

ELECTRONIC HEALTHCARE DATA

Learn more about CTTI’s work on the Mini-Sentinel pilot project and IMPACT-Afib study.

LARGE SIMPLE TRIALS

Read CTTI’s manuscript on enabling the potential increased efficiency and reduced costs that come with using a large simple trial.