Novel Endpoints

Recent CTTI Publication Explores Educational Strategies for Increasing Use of Anticoagulants Among AFib Patients

Posted on by Hannah Faulkner

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

Posted on by Hannah Faulkner

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. 

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Posted on by Hannah Faulkner

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the benefits of these methods, their use is still not widely accepted among sponsors, investigators, and regulators. Recently, there has been growing interest across the clinical trials ecosystem in advancing the use of disease progression modeling to improve clinical trial quality and efficiency and inform regulatory decision making. Disease progression modeling leverages data from a variety of sources, improving trial diversity and combining many different models to help inform decision making. 

To promote these methods, CTTI has started a new project engaging a variety of stakeholders and experts in the development of recommendations and resources for the application of disease progression modeling in clinical trials. Through this project, CTTI will generate case studies detailing successful applications of disease progression modeling, a framework for the execution of disease progression modeling in clinical trials, a set of recommendations for the implementation of disease progression modeling in clinical trials, and a review paper detailing relevant disease progression modeling applications. This project aims to improve trial and clinical development efficiency by increasing the recognition, value, and consistent use of disease progression modeling. CTTI’s work in this area will also help to advance the broader application of modeling and simulation for trial design and regulatory decision making. 

To generate recommendations and resources supporting the application of disease progression modeling in clinical trials, CTTI will utilize a variety of iterative evidence generating strategies—including a scoping review assessing the landscape of disease progression modeling applications and an expert meeting discussing the barriers to disease progression modeling application and avenues for advancement. 

Through this work, CTTI will create recommendations and resources for designing clinical trials with a quality approach that maximally leverages available data—in alignment with CTTI’s Transforming Trials 2030 vision.