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CTTI Holds Meeting to Discuss Embedding Clinical Trials in Health Care Settings
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on May 11 to discuss recommendations for embedding elements of clinical trials into routine care. Different elements of clinical trials can be embedded into care, such as randomization, administration of study drug, and data acquisition. While this can promote the development of a learning health care system—where research will inform practice and practice will inform research—achieving this is complicated, and clarity is needed about how to operationalize the integration. Leaders and key stakeholders from across the clinical trials community participated in the meeting to help refine the recommendations and begin to strategize their implementation of them.
Meeting attendees identified some important themes:
- Alignment of research and care is needed. Data collected during routine care should be good enough to support both high quality care and research.
“We would do well to clearly identify the high level of alignment needed for patient care and research. Researchers need to get less special about themselves. We want to identify consequential decisions, when that decision occurs, why it matters, and when and how will we measure the consequences of that decision. Those three goals are 100% identical between research and care.” – Health Care System Provider
- We need transparency about roles and responsibilities. Embedding research into care will involve many stakeholders, including investigators, research sponsors, health care providers, regulatory bodies, operational technology providers, clinical research organizations, patient advocacy groups, health system leaders, funders, payers and, of course, patients.
“The front-line troops carrying out embedded trials – patients and clinicians – need to see a compelling research question or need that is personally valuable in the context of everything else they are trying to do. Some of that can be done by deep embedding in their environment to understand their needs.” – Funder
- There is important work ahead of us. Meeting attendees provided feedback on the set of draft recommendations and suggested new tools to help implement the recommendations such as a decision tree tool to evaluate what trial elements could be embedded, a workflow support tool to clarify the kind of support needed to embed trial elements, and a list of technology examples that have or could enable embedding.
CTTI is now using these findings—along with other research results and multi-stakeholder discussions—to refine recommendations and develop resources for release in late 2022. The project team will host another expert meeting on this topic in September.
Recent CTTI Publication Investigates HABP/VABP Risk and Antibiotic Trial Eligibility for Hospitalized Patients in Europe
Topics Included: Safety
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A new CTTI publication investigates the prospective identification of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) risk factors and antibiotic trial eligibility among hospitalized, critically ill patients at seven European hospitals. The study, PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts, published in Open Forum Infectious Diseases, evaluated 888 critically ill patients receiving ventilation or high levels of supportive oxygen and used existing clinical criteria to predict which patients would develop HABP/VABP. The researchers compared these results to those of a prior CTTI study of U.S. patients, finding that a higher proportion of European patients who were treated for possible HABP/VABP met the pneumonia definition compared to their counterparts in U.S. hospitals. The European patients were also more likely to meet common antibiotic trial eligibility criteria. The results could be applied to the development of new strategies to improve registrational trial feasibility and foster the development of much needed new antibacterial treatments for HABP/VABP.
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Recent CTTI Publication Explores Educational Strategies for Increasing Use of Anticoagulants Among AFib Patients
A new CTTI publication from collaborators including CTTI investigates the impact of educational mailings in increasing the use of oral blood thinners among patients with atrial fibrillation (AFib). For many of these patients, use of blood thinners can reduce their stroke risk by about 70%. Despite current guideline recommendations, only about half of eligible patients with AFib are routinely taking blood thinners, and patient interviews have revealed that patients are undereducated about stroke risk and the potential benefits of preventative blood thinner use. To explore solutions to this educational gap, the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) identified and sent educational mailings to a subset of eligible patients enrolled in health plans that participate in the FDA’s Sentinel System. The resulting paper, published in JAMA Network Open, found that these mailings were only minimally successful in increasing blood thinner use among AFib patients. These results indicate that more intensive educational interventions may be needed to address this problem.
This trial was the first ever to leverage the FDA-Catalyst System, which combines data from interactions with patients and/or providers with data from the Sentinel Infrastructure. The collaboration included Aetna, Duke Clinical Research Institute, the Harvard Pilgrim Health Care Institute’s Department of Population Medicine, Harvard Pilgrim Health Care, HealthCore Anthem, Humana, Optum, and the FDA.
CTTI Publication Investigates Use of Preventive Statins among Patients with Cardiovascular Disease
A new CTTI publication, published in the Journal of the American College of Cardiology, investigates the use of preventive, high-intensity statins among patients diagnosed with atherosclerotic cardiovascular disease (ASCVD). The study, which used pharmacy and medical claims data from a commercial health plan, found substantial underuse of statins among insured ASCVD patients. Most notably, younger patients and women were among those less likely to be prescribed any statin. In those prescribed a statin, women and older patients were less likely to receive high-intensity statins. This paper was based on exploratory work done by CTTI with Duke and HealthCore as background to inform a potential randomized intervention to improve the use of guideline recommended high-intensity statins.