Please Wait...

Integrations of Cardiac Endpoints

Jeff Heilbraun Integrations of Cardiac Endpoints in International Clinical Trials. May 2020.

Abstract: 

Bioclinica CTMS

Looking at the pharmaceutical R&D arena, there is continued growth in the field of oncology research.  As with any other field, efficacy is a primary goal and endpoint for developing oncologic agents.  Based on the therapeutic area the approach to safety endpoints is defined through a benefit-risk perspective.  The success in the field of oncology research has been significant and patient’s life expectancy following treatment continues to increase.  It was and is well recognized that many of the oncology therapeutic treatments are cardiotoxic in nature.  With this recognition that some treatments had a cardiac safety profile and that patients were in fact living longer, the medical and scientific community began to focus on the cardiac safety considerations and endpoints and a new specialty arose which incorporated both the cardiovascular safety endpoints as well as the treatment of the cancer, leading to the establishment of the field of Cardio-Oncology.

From a drug development and regulatory perspective there is continued momentum in this focus and specialty which can be seen coming from the American College of Cardiology (cardio-oncology roundtable) to the American Heart Association’s Cardio-Oncology Vascular and Metabolic Perspectives, scientific position paper.

This article will provide insight and direction related to the integration of cardiac safety (ECG and blood pressure) as well as cardiac imaging endpoints into oncology clinic trials.  The article will include a review of the present regulatory considerations as well as an overview of both technologies and modalities for the assessment of cardiac safety and imaging endpoints within a study from a benefit – challenge perspective and how the design and data are positioned to address specific safety endpoints within the unique oncology drug development environment.

 

    

READ ARTICLE     

 

    

 

    

 

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Integration of #eTMF and #CTMS eliminates redundancies, improves workflows & enables greater study control. Join th… https://t.co/dnqwBLTvy3
Bioclinica (2 hours ago)
Save time and minimize risk with Bioclinica’s Clinical Trial Management System (CTMS) Starter Package. A full-featu… https://t.co/MW4e031hXf
Bioclinica (Yesterday)
Bioclinica’s Resale #IRT offers flexible configuration, delivery in weeks not months, & an affordable, predictable… https://t.co/vVjH0VLpSv
Bioclinica (6 days ago)
The Clinical Trial Management System (CTMS) Starter Package from Bioclinica saves time and minimizes the risk often… https://t.co/VRGMjKlzL4
Bioclinica (2 weeks ago)
We are pleased to announce @directbiologics will leverage Bioclinica's IRT solution for its EXIT #COVID19 study. Th… https://t.co/Iun6UrL6Bt
Bioclinica (2 weeks ago)
The integration of Bioclinica CTMS & eTMF with SharePoint enable teams to work in familiar programs & remote work a… https://t.co/QRBt1sdljh
Bioclinica (3 weeks ago)