When research data is collected separately from a clinical care setting, studies may produce results that do not reflect the real-world performance of medical products in the populations that will use them. We can bridge these gaps by embedding adequate and well-controlled trials into regular clinical practice. Patient portals can be used to deliver consent information in a variety of formats, improving participants’ understanding of trial activities and risks and facilitating authentic informed consent. Integrating clinical trials with routine health care can increase the efficiency of studies and facilitate the discovery of effective treatments. In CTTI’s 2030 vision for clinical trials:
- Trials are integrated within learning health care systems—where science, informatics, incentives, and culture are aligned for continuous improvement and innovation, with best practices seamlessly embedded in the delivery process and new knowledge captured as an integral by-product of the delivery experience.
- Clinical trial data are collected via the electronic health record (EHR), with additional data collected only if unavailable in the EHR.
- Informed consent for clinical trial participation is integrated into the care process. Consent policies are directly tied to risk mitigation in a clinical study and are easily understood by trial participants.
- Health care systems and health plans are involved in planning studies and support the integration of trials into regular clinical practice in order to facilitate engagement of care providers, recruitment, data collection from EHRs, and uptake of trial results.
Resources
Site Planning | Expert Meetings
Embedding Trials in Clinical Practice Expert Meetings
Fully Integrated into Health Processes
May 11, 2022 & September 21, 2022 CTTI Project: Trials in Clinical Practice SHARE TO:
Site Planning | Resources
Randomized, Embedded, Multifactorial Adaptive Platform Trial Case Example: Evaluating Treatment Options for Community-Acquired Pneumonia
Randomized, Embedded, Multifactorial Adaptive Platform Trial Case Example: Evaluating Treatment Options for Community-Acquired Pneumonia
Site Planning | Resources
Thrombase Aspiration in Myocardial Infarction (TASTE) Case Example: Learning from an Embedded Registry Trial
Thrombase Aspiration in Myocardial Infarction (TASTE) Case Example: Learning from an Embedded Registry Trial
Site Planning | Resources
Diuretic Comparison Project Case Example: Learning from an Integrated Health System
Diuretic Comparison Project Case Example: Learning from an Integrated Health System
Site Planning | Resources
I-SPY Trial Case Example: Using an Embedded Trial to Identify New Treatments for Breast Cancer
I-SPY Trial Case Example: Using an Embedded Trial to Identify New Treatments for Breast Cancer
Site Planning | Resources
RECOVERY Trial Case Example: Using an Embedded Trial to Identify Treatments for COVID-19
RECOVERY Trial Case Example: Using an Embedded Trial to Identify Treatments for COVID-19
Site Planning | Recommendations
Embedding Clinical Trial Elements into Clinical Practice
Embedding Clinical Trial Elements into Clinical Practice