Scientific Focus
Cardiovascular safety concerns have become a leading cause of drug marketing withdrawals and label warnings on marketed drugs. Quintiles is working to improve the understanding and evaluation of cardiac safety by incorporating medical, scientific and regulatory advances into the current practices of drug development.
Quintiles experts are well-versed in the changing regulatory landscape of cardiac safety. Through our dedicated cardiac safety research team, we conduct empirical research that is published in peer-reviewed biomedical journals and presented at scientific and industry conferences. See examples of our recent research and publications below.
| The Contribution of Early-phase Clinical Data to a Drug's Integrated Cardiac Safety Portfolio September 2011 |
Study design is essential to reducing costs and minimizing the time in clinical development. In this peer reviewed journal, Vaibhav Salvi and Rick Turner, Cardiac Safety Services, Quintiles examine the role of cardiac safety in early phase study design and the financial and time benefits it produces. Authors: Rick Turner, PhD Senior Scientific Director, Integrated Cardiovascular Safety, Cardiac Safety Services, Quintiles Vaibhav Salvi, MBBS, DCR, Member, Research and Reports section, Cardiac Safety Services, Quintiles | |
More of our perspectives you might be interested in: Cardiovascular Safety Watch - Part 2: Regulatory Landscape for Off-Target Blood Pressure Assessment November 2011 This column provides further discussion related to a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, based on feedback from additional cardiovascular safety conferences. Cardiovascular Safety Watch - DIA Cardiac and Cardiovascular Safety Conferences September 2011 This column reviews the 2nd DIA Cardiac Safety Conference in Japan (held September 5th and 6th in Tokyo), and previews the 5th DIA European Cardiovascular Safety Conference, held on November 3rd and 4th in Barcelona. Cardiovascular Safety Watch - Regulatory Landscape for Off-Target Blood Pressure Assessment July 2011 This column discusses a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, and the challenges of deciding which parameter(s) to focus upon, and how to determine thresholds of regulatory concern. CardioCheck A Biomarker Assay Program Designed for Cardiotoxicity Testing in Early Phase Pre-clinical Drug Development May 2011 Prospective identification and potential amelioration of cardiotoxicity is a critical component of contemporary drug development. Accordingly, the Quintiles CardioCheck Program has been created to provide rapid insight into potential cardiotoxic influences of pharmaceutical compounds. While screening a library of compounds in the early phases of development to choose the appropriate candidate for clinical development is extremely useful, the CardioCheck Program can also be utilized for compounds that are farther down the clinical development path to identify and potentially ameliorate negative influences the drug may have on the heart. Additionally, the program can identify pharmaceutical drugs that demonstrate cardio-protective effects with regard to mitochondrial health and energy homeostasis. The myriad of tests performed in the CardioCheck program enable the pharmaceutical companies to make quick and informative decisions on drugs that may cause potential cardiotoxicity. In addition, it enables the pharmaceutical companies to understand the cause of the cardiac myocyte toxicities of the drug and find ways to mitigate it. Establishment and Operation of Clinical Endpoint Committees Best Practice for Implementation Across the Biopharmaceutical Industry May 2011 This White Paper provides a detailed account of the operation of Clinical Endpoint Committees. It discusses how they are formed, how information is sent to members of the committee, how disagreements between committee members with regard to the confirmation of a suspected event are handled, and the latest developments in electronic adjudication processes. Cardiovascular Safety Watch - DIA/FDA Conference on Cardiovascular Safety in Drug Development May 2011 This column provides a report of the DIA/FDA conference entitled “Cardiovascular Safety in Drug Development: State-of-the-Art Assessments,” held in Washington DC on 14-15th April 2011. Centralised Endpoint Adjudication in Cardiovascular Outcome Studies Composite Endpoints, Risk Ratios, and Clinical Endpoint Committees March 2011 This paper provides a succinct overview of Clinical Endpoint Committees, their role in the independent adjudication of suspected cardiovascular events during clinical trials, and the need for their employment in clinical development programs for new antidiabetic drugs for Type 2 Diabetes Mellitus. Cardiovascular Safety Watch - Assessments for New Oncologic Agents March 2011 This column discusses cardiovascular safety assessments for new oncologic agents, and illustrates how benefit-risk balances differ in different circumstances. Cardiovascular Safety Watch - Introduction to Cardiac Safety Research Consortium January 2011 This column provides an introduction to the Cardiac Safety Research Consortium (CSRC) and a review of its 2010 Annual Meeting and accompanying Pediatric Drug and Devices Cardiovascular Safety Think Tank, in December 2010 at the FDA Headquarters (Silver Spring, Maryland). The Science of Cardiac Safety November 2010 Makes the case for a centralized approach to Phase III ECG data collection to ensure quality and integrity — while still realizing cost savings. Published by Applied Clinical Trials (ACT). Cardiovascular Safety Watch — On the FDA ruling on rosiglitazone November 2010 Following advisory committees' recommendations concerning rosiglitazone, the FDA did not withdraw the drug but did require a risk evaluation and mitigation strategy. Cardiovascular Safety Watch — On initial recommendations on rosiglitazone September 2010 A review of the FDA advisory committees’ recommendations on cardiac safety risks associated with rosiglitazone, a drug for type 2 diabetes. Cardiovascular Safety Watch — On an integrated approach to cardiac safety July 2010 Can non-clinical investigations predict the degree of proarrhythmic liability in clinical trials? Integrated Cardiovascular Safety June 2010 Published by Applied Clinical Trails (ACT) Significant focus on proarrhythmic cardiac safety assessment has added new pressure on clinical development programs. Both ICH Guideline E14 and the FDA Guidance for Industry recommend new approaches that integrate clinical, regulatory, and statistical science. This three-pronged approach helps alert drug sponsors earlier of unacceptable risks and may continue to prove useful as assessment horizons broaden. Japanese Cardiac Safety Requirements — The Rising of a New Regulatory Landscape Summer 2010 Japan’s PDMA recently implemented ICH Guideline E14. What are the implications for drug developers marketing in this country? As seen in IPI (International Pharmaceutical Industry). Cardiovascular Safety Watch — On automating ECG interval readings May 2010 Dr. Rick Turner's inaugural cardiac safety column in Journal for Clinical Studies discusses the automation of ECG interval readings. Applications of Modeling and Simulation in Cardiac Safety Studies May 2010 Three case studies demonstrate the important role modeling and simulation can play in the design as well as analysis of data from TQT studies. Assessing Cardiac Safety Throughout Clinical Development May 2010 A discussion of the ramifications for an integrated cardiac safety program. Published by DIA Global Forum. EMA's Guidance on New Antidiabetic Drug Development May 2010 A comparison of the January 2010 EMA draft guideline on antidiabetic drug development, including the assessment of cardiovascular safety, with similar 2008 FDA guidelines. Interpreting the Interval April 2010 An in-depth review of the design, methodology, analysis and interpretation of the ICH Guideline E14 Thorough QT/QTc study. Published by European Pharmaceutical Contractor. Regulatory Landscapes for Future Antidiabetic Drug Development January 2010 A brief overview of the FDA's guidance on assessing cardiovascular risk and the potential implications for antidiabetic drug development. Published by Journal for Clinical Studies. New FDA Guidance on Antidiabetic Therapies December 2009 Overview of the 2008 FDA guidance on assessing cardiovascular risks for new diabetes drugs and the implications for future diabetes clinical trials. Applications of Modeling and Simulation (M&S) in Cardiac Safety Studies December 2009 How using modeling and simulation can leverage data from early clinical studies to design optimal TQT studies. Presented as part of the DIA Global Forum webinar on cardiac safety. Cardiac Safety in Clinical Research September 2010 Highlights of work by the Cardiac Safety Research Consortium on the evaluation of ventricular arrhythmias in early clinical pharmacology trials. Z-Score for Benchmarking Reader Competence in a Central ECG Laboratory January 2009 To ensure consistent quality in TQT studies, the Z-Score method offers an easy, reliable and robust method of defining ECG reader competence. Published by Annals of Non-invasive Electrocardiology. | |
