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Dear Friends and Colleagues,
The mission of the HFC has focused largely on clinical trials, and the impact of COVID-19 on clinical research will be significant. The FDA has issued the following guidance with suggestions and recommendations. We have offered to collect any questions not addressed in the guidance and pass them along on behalf of HFC members. We hope this will be helpful in answering the many questions we are all facing.
Kind regards,
Mona Fiuzat, Chris O’Connor, JoAnn Lindenfeld, Bill Abraham, Mitch Psotka, Bram Zuckerman, Norman Stockbridge
Heart Failure Collaboratory Co-Chairs and Members
Click the link below to read a blog by Ankeet Bhatt, MD, MBA posted on CVCTCardioBrief.
“Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry”
Click here for more information: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-considerations-clinical-trials-during-covid-19-public-health-emergency-guidance-industry
“The purpose of this notice is to provide guidance outlining the flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies, that are impacted by the declared public health emergency for COVID-19.”
Click here for more information: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html
In 2019, the Heart Failure Collaboratory launched the HFC/HFSA Research Awards to recognize site based research performance in clinical trials, including top PI’s, Study Coordinators, and Sites. Awards are presented annually during the HFSA Scientific Sessions. Awardees have demonstrated meaningful involvement in a clinical trial listed on ClinTrials.gov with a range of accomplishments including meritorious achievement in trial design, execution/enrollment, citizenship, attendance, and/or contribution to scientific content in a trial in which they were involved.
The annual 2020 call for nominations in now open until Friday, July 17. Awards will be presented at the HFSA Virtual Annual Scientific Sessions, October 2 – 5, 2020. For more information or questions about how to nominate, please email us at : hfcollaboratory1@inova.org.
The Heart Failure Collaboratory is proud to announce the winners of the HFC – HFSA Research Network Awards. In its inaugural year, this joint effort recognized individuals and sites in the following categories: Research Site, Principal Investigator and Site Coordinator. Below is a list of all awardees:
Pictured left to right:
Stephen Heitner, MD, Mitchell Psotka, MD, PhD, Chris O’Connor, MD, HFSA President 2017-2018, Randy Starling, MD, HFSA President 2018-2019, Biykem Bozkurt, MD, HFSA President 2019-2020, Palak Shah, MD
Biykem Bozkurt, MD, HFSA President 2019-2020, Randy Starling, MD, HFSA President 2018-2019, Palak Shah, MD, Mitchell Psotka, MD, PhD, Venkatesh Nadar, MD, Anjali Owens, MD, Chris O’Connor, MD, HFSA President 2017-2018
Biykem Bozkurt, MD, HFSA President 2019-2020, Randy Starling, MD, HFSA President 2018-2019, Amanda Radle, MS, Lydia McGowan, MS, CCRP, Chris O’Connor, MD, HFSA President 2017-2018