In this blog we share a case study of work our strategic consulting team conducted supporting accurate event prediction for a cardiovascular outcomes research trial using the Major Adverse Cardiac Events ( MACE) composite endpoint.
Case Study: Accurate Event Prediction in a Cardiovascular Outcomes Research Trial
Sep 20, 2017 8:50:19 AM
Topics: Cardiovascular, biostatistics, time to event trials
Adaptive Design Approaches from Cardiovascular Clinical Trialists Forum
Jan 16, 2017 8:41:00 AM
The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the spectrum of opinion leaders, clinical trialists, investigators, regulators, statisticians and practitioners to address the most pressing questions in cardiovascular clinical development today. At the December conference, eminent biostatisticians Cyrus Mehta and Stuart Pocock...
Topics: Cyrus Mehta, Cardiovascular, Cytel Events, biostatistics, adaptive designs, adaptive trials
Statistical Primer for Cardiovascular Research
Oct 13, 2015 4:39:00 PM
In honor of World Obesity Day (celebrated on Oct. 11 2015) here is an American Heart Association Statistical Primer on Cardiovascular Research. Cardiovascular outcome trials (sometimes called CVOTs) are clinical trials that are critical for determining the safety of new anti-obesity and diabetes drugs. Early CVOTs like TECOS and SAVOR-TIMI enrolled over 14,000 and 16,000 patients respectively.
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Topics: Cardiovascular
Why You Should Not Power for Superiority Upfront: Promising Zone Clinical Trials with "Adaptive Switch"
Jun 26, 2015 12:00:06 PM
Powering a trial for superiority can be financially risky. In some instances it may also prove unnecessary.
Topics: Cyrus Mehta, Promising Zone, Cardiovascular, Adaptive Clinical Trials, Adaptive Finance
A Cautionary Tale about Composite Endpoint Construction: The ARISE Trial
Jun 18, 2015 5:38:45 PM
In August 2006 AstraZeneca completed the ARISE trial, which aimed to determine whether AGI-1067 was effective in reducing atherosclerosis in patients with acute coronary artery disease [1][2]. A double-blind, placebo controlled, Phase 3 trial, the primary efficacy endpoint was a composite endpoint which included major adverse cardiovascular events (MACE) like cardiovascular death, resuscitated...
Topics: Cardiovascular, Composite Endpoints
Aligning Clinical Development & Regulatory Objectives for Cardiovascular Outcome Trials
Jun 11, 2015 5:21:09 PM
When the FDA first began to require pharmaceuticals to perform cardiovascular outcome trials to establish the safety of certain new drugs, many worried that this new regulatory requirement would diminish investments in therapeutic areas like diabetes and obesity [1]. CVOTs are typically designed as massive time-to-event trials that need to enroll several thousands of patients to establish safety...
Topics: Cardiovascular, Clinical Development Strategy, Adaptive Clinical Trials
How to Plan Interim Looks in Adaptive Clinical Trials: 3 Strategies
Mar 19, 2015 5:26:00 PM
A well-timed interim analysis can generally supply added benefits to the operational and administrative aspects of a clinical trial. Particularly when clean data and safety adjudications provide information that is instrumental for stopping a trial early or informing sensitive interim decisions, the timing of an interim look may play a crucial role in leveraging all of the flexibility that a...
Topics: Interim Analyses, Cardiovascular, Cytel Events, Statistical Innovations in Clinical Development
How to Shorten a Cardiovascular Outcome Trial By Two Years
Feb 10, 2015 5:28:00 PM
Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients.
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Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy, Adaptive Clinical Trials
Clinical Development & Statistical Methodology for Cardiovascular Risk Assessment
Feb 3, 2015 2:00:00 PM
A new publication co-authored by Cytel Co-Founder and President Cyrus Mehta considers a range of clinical development methods for cardiovascular outcome trials. Cardiovascular outcome trials, (often referred to as CVOTs), reflect safety standards implemented by the FDA and EMA to determine whether or not new drugs impose undue cardiovascular risk on patients. CVOTs typically occur after Phase 3...
Topics: Cardiovascular, Group Sequential, Adaptive Clinical Trials
Clinical Impact Beyond 'Time to First' Analyses
Oct 21, 2014 9:00:00 AM
Every year, the East Users Group Meeting brings together notable experts from industry and academia to discuss the future of biostatistical advances in clinical trials, as well as the role of software in facilitating these breakthroughs. In honor of this year’s event, which will be taking place at the Loews Hotel in Philadelphia on October 22, the Cytel Blog will spend the next couple of weeks...
Topics: East, East 6.3, Statistical Programming, Statistical Puzzles, Statistical Analysis, Cardiovascular
FDA-Industry Session on Cardiovascular Outcome Trials: Mehta on EXAMINE Trial’s Promising Zone Design
Sep 9, 2014 10:41:00 AM
The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium...
Topics: Cyrus Mehta, Promising Zone, Trial Design, FDA, Interim Analyses, Cardiovascular, Adaptive Clinical Trials