Transforming Clinical Research
Creating processes and tools to enhance the clinical research enterprise
Thanks to new technologies and the increasing use of electronic medical records, the health care system is producing large amounts of patient data from a wide range of sources. At the same time, clinical research is increasingly concerned with the needs of patients and caregivers, and with developing the evidence needed to help patients, families and doctors make the best choices possible. But this brave new world of patient-centered research brings significant challenges. When doing research, how do we manage and use patient information most effectively and at the same time, ensure patients’ privacy and safety?
Traditional research policies were not necessarily designed to accommodate the use of data from multiple sources and settings, or for that matter, patients’ increasing desire to play a more active role in the research process. Government regulators, researchers, and others are now struggling to create a 21st Century clinical research infrastructure that provides the evidence all of us need to improve health and health care.
To that end, CMTP partners with government, academia, and industry to address these barriers and enhance the clinical research enterprise. For example, we are collaborating on projects with the Patient Centered Outcomes Research Institute (PCORI) and its national Patient Centered Outcomes Research Network, PCORnet. CMTP is is leading the PCORnet Patient and Consumer Engagement Task Force. In addition, CMTP is working with the Chicago Area Patient Centered Clinical Outcomes Research Network—one of eight across the nation funded by PCORI—which will model how health institutions improve outcomes and drive down costs for both rare and common conditions.
In our clinical research projects, CMTP:
- Investigates and develops innovative approaches to streamlining informed consent for community-based CER studies.
- Integrates diverse stakeholder values and priorities in the design of large data collection systems and registries.
- Develops tools and processes for the judicious selection of pragmatic design elements that are most meaningful to end users.
- Facilitates stakeholder-driven protocol refinement of pragmatic clinical trials.
- Collaborates with researchers, healthcare systems, and patients to identify novel governance approaches for research networks where stakeholders are active partners.
In past projects, we have brought patient and consumer advocates together to tackle complex issues such as registries for radiation therapy and artificial joint replacement, and breast cancer risk stratification. To learn about more clinical research projects, visit our Resource Center.