Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi‐Stakeholder Think Tank

نویسندگان

  • Rachel D. Torok
  • Jennifer S. Li
  • Prince J. Kannankeril
  • Andrew M. Atz
  • Raafat Bishai
  • Ellen Bolotin
  • Stefanie Breitenstein
  • Cathy Chen
  • Thomas Diacovo
  • Timothy Feltes
  • Patricia Furlong
  • Michael Hanna
  • Eric M. Graham
  • Daphne Hsu
  • D. Dunbar Ivy
  • Dianne Murphy
  • Lisa A. Kammerman
  • Gregory Kearns
  • John Lawrence
  • Brigitte Lebeaut
  • Danshi Li
  • Christoph Male
  • Brian McCrindle
  • Pierre Mugnier
  • Jane W. Newburger
  • Gail D. Pearson
  • Vasum Peiris
  • Lisa Percival
  • Miriam Pina
  • Ronald Portman
  • Robert Shaddy
  • Norman L. Stockbridge
  • Robert Temple
  • Kevin D. Hill
چکیده

Rachel D. Torok, MD; Jennifer S. Li, MD; Prince J. Kannankeril, MD; Andrew M. Atz, MD; Raafat Bishai, MD; Ellen Bolotin, MD, PhD; Stefanie Breitenstein, MD; Cathy Chen, MD, MSc; Thomas Diacovo, MD; Timothy Feltes, MD; Patricia Furlong, BSN, MS; Michael Hanna, MD; Eric M. Graham, MD; Daphne Hsu, MD; D. Dunbar Ivy, MD; Dianne Murphy, MD*; Lisa A. Kammerman, PhD; Gregory Kearns, PharmD, PhD; John Lawrence, MD; Brigitte Lebeaut, MD; Danshi Li, MD, PhD; Christoph Male, MD, MSc; Brian McCrindle, MD; Pierre Mugnier, PhD; Jane W. Newburger, MD, MPH; Gail D. Pearson, MD, ScD; Vasum Peiris, MD, MPH; Lisa Percival, MS; Miriam Pina, MD; Ronald Portman, MD; Robert Shaddy, MD; Norman L. Stockbridge, MD, PhD; Robert Temple, MD; Kevin D. Hill, MD, MSCI*

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.

This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6, 2013. Attention was focused on the lack of clarity concerning the need for end point adjudication in ...

متن کامل

Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium.

This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank cosponsored by the Cardiac Safety Research Consortium, the US Food and Drug Administration, and the American College of Cardiology, held at American College of Cardiology's Heart House, Washington, DC, on February 19, 2014. Studies to assess cardiovascular (CV) risk of a new...

متن کامل

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank c...

متن کامل

Archives of Public Health

Background: National health surveys are sometimes used to provide estimates on risk factors for policy and program development at the regional/local level. However, as regional/local needs may differ from national ones, an important question is how to also enhance capacity for risk factor surveillance regionally/locally. Methods: A Think Tank Forum was convened in Canada to discuss the needs, c...

متن کامل

Enhancing capacity for risk factor surveillance at the regional/local level: a follow-up review of the findings of the Canadian Think Tank Forum after 4 years

BACKGROUND National health surveys are sometimes used to provide estimates on risk factors for policy and program development at the regional/local level. However, as regional/local needs may differ from national ones, an important question is how to also enhance capacity for risk factor surveillance regionally/locally. METHODS A Think Tank Forum was convened in Canada to discuss the needs, c...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 7  شماره 

صفحات  -

تاریخ انتشار 2018