Reception – 7:30pm (December 9, 2012)
Reception in the Capitol Ballroom at the DoubleTree Hotel (7:30pm)8727 Colesville Road, Silver Spring, MD
CSRC Annual Meeting 2012 (December 10, 2012)
This meeting brings together the CSRC Membership, Key Regulators, Pharmaceutical and Device Developers, CRO’s, and Academicians to Discuss some of the Major Issues in Device Development.
This year there will be a special session on best practices for CV Safety assessments, including the use of outcome studies in the evaluation of new chemical entities and will highlight new approaches and technologies that may impact the need for dedicated outcome trials.
|Commercial / Industry Non-Members
|Commercial / Industry Members
|Academic / Professional Society / Non-profits
Specific topics include:
- CV Safety Assessment in Drug Development — The need of individual dedicated studies vs. monitoring throughout development and risk management
- The potential impact of highly reliable “real time” post-marketing assessments to reduce the amount of data necessary during Phase 3 trials
- CV Safety — What is the role of CV adjudication, Key Issues, and when is it needed?
- Missing data in outcome trials — Implications and Prevention
- The use of large databases to better understand population and Drug CV risk
- QT/Arrhythmia Issues: Can the Thorough QT Study be replaced?
- Is more intensive evaluation of BP increases needed during drug development?
Open Forum: Review and Finalize cardiovascular Case Report Forms for use in non-cardiovascular clinical trials. (December 11, 2012)
Cardiovascular Safety Signals often arise in clinical development programs involving non-cardiovascular compounds. Unlike typical cardiovascular trials in which rigorous information is collected on all CV adverse events, in non-CV trials close follow-up of cardiovascular AEs can be very variable. This variability can be due to the relatively low frequency of these CV events as well as different levels of awareness and vigilance for CV signals in these settings. The CSRC, in conjunction with the FDA, is proposing the creation of specific cardiovascular case report forms to be used in non-CV drug trials that can assist in the proactive collection of information when CV events are reported. It is envisioned that the information collected in these CV CRFs would contain the minimal amount of information required for a post-hoc adjudication of cardiovascular events, if needed, from a clinical development program without placing undue burden on a clinical investigator. Ultimately, these forms should facilitate better detection, evaluation, and potential management of cardiovascular safety signals. These forms will be posted to a public website when completed.
Please find the forms to be reviewed, below:
- Cerebrovascular Events Stroke (CVA) & Transient Ischemic Attack (TIA)
- Congestive Heart Failure
- Deep Venous Thrombosis (DVT) Pulmonary Embolism (PE)
- Myocardial Infarction Unstable Angina
- Peripheral Arterial Thromboembolism
- Pulmonary Hypertension
Additional Meeting Materials: