Cardiovascular Sciences Research Consortium Think Tank
Recent advances in remote monitoring technologies have empowered continuous tracking of physiologic parameters with high accuracy and granularity. However, there are important differences in the hardware, data processing, and feedback streams of individual devices which can impact the use of digital...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-09-01
|
| Series: | JACC: Advances |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772963X25004843 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849398200141611008 |
|---|---|
| author | Krishna Pundi, MD Sanjeev Bhavnani, MD Rosalyn Adigun, MD, PharmD Jose Vicente, PhD Rajesh Ghosh, MBA David Albert, MD Waqaas Al-Siddiq, DBA Charles Benson, MD, PhD Antoniu Fantana, PhD Jennifer C. Goldsack, MBA Salim F. Idriss, MD, PhD Gregory Marcus, MD, MAS Pamela Tenaerts, MD, MBA Mintu P. Turakhia, MD, MAS Jonathan Seltzer, MD, MBA |
| author_facet | Krishna Pundi, MD Sanjeev Bhavnani, MD Rosalyn Adigun, MD, PharmD Jose Vicente, PhD Rajesh Ghosh, MBA David Albert, MD Waqaas Al-Siddiq, DBA Charles Benson, MD, PhD Antoniu Fantana, PhD Jennifer C. Goldsack, MBA Salim F. Idriss, MD, PhD Gregory Marcus, MD, MAS Pamela Tenaerts, MD, MBA Mintu P. Turakhia, MD, MAS Jonathan Seltzer, MD, MBA |
| author_sort | Krishna Pundi, MD |
| collection | DOAJ |
| description | Recent advances in remote monitoring technologies have empowered continuous tracking of physiologic parameters with high accuracy and granularity. However, there are important differences in the hardware, data processing, and feedback streams of individual devices which can impact the use of digital health technologies when evaluating safety in studies. This expert panel is the result of a think tank through a public–private partnership of the Cardiovascular Sciences Research Consortium and the U.S. Food and Drug Administration. The white paper discusses regulatory considerations for remote monitoring through digital health technologies to provide a framework for their use when evaluating safety or adverse events. It also provides practical recommendations and best practices on the implementation of these technologies into clinical trials through a scientific, technical, and operational lens. This manuscript does not constitute regulatory guidance. |
| format | Article |
| id | doaj-art-c8e806eed56d4fcba59f7413d76c5893 |
| institution | Kabale University |
| issn | 2772-963X |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JACC: Advances |
| spelling | doaj-art-c8e806eed56d4fcba59f7413d76c58932025-08-20T03:38:40ZengElsevierJACC: Advances2772-963X2025-09-014910205910.1016/j.jacadv.2025.102059Cardiovascular Sciences Research Consortium Think TankKrishna Pundi, MD0Sanjeev Bhavnani, MD1Rosalyn Adigun, MD, PharmD2Jose Vicente, PhD3Rajesh Ghosh, MBA4David Albert, MD5Waqaas Al-Siddiq, DBA6Charles Benson, MD, PhD7Antoniu Fantana, PhD8Jennifer C. Goldsack, MBA9Salim F. Idriss, MD, PhD10Gregory Marcus, MD, MAS11Pamela Tenaerts, MD, MBA12Mintu P. Turakhia, MD, MAS13Jonathan Seltzer, MD, MBA14Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA; Department of Medicine, Stanford University School of Medicine, Stanford, California, USA; Address for correspondence: Dr Krishna Pundi, Division of Cardiovascular Medicine, Department of Medicine, Stanford University, 300 Pasteur Drive, H2146, Stanford, California 94305, USA.Department of Cardiology, Scripps Clinic, La Jolla, California, USADepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USATranslational Cures, Inc, Washington, DC, USANovartis, Cambridge, Massachusetts, USAAliveCor Inc., Mountain View, California, USABiotricity, Inc, San Francisco, California, USAEli Lilly, Indianapolis, Indiana, USAEli Lilly, Indianapolis, Indiana, USAThe Digital Medicine Society, Boston, Massachusetts, USADivision of Pediatric Electrophysiology, Duke University Medical Center, Durham, North Carolina, USADivision of Cardiology, University of California, San Francisco, San Francisco, California, USAMedable, Inc., Palo Alto, California, USADepartment of Medicine, Stanford University School of Medicine, Stanford, California, USACardiovascular Safety Research Consortium, Durham, North Carolina, USARecent advances in remote monitoring technologies have empowered continuous tracking of physiologic parameters with high accuracy and granularity. However, there are important differences in the hardware, data processing, and feedback streams of individual devices which can impact the use of digital health technologies when evaluating safety in studies. This expert panel is the result of a think tank through a public–private partnership of the Cardiovascular Sciences Research Consortium and the U.S. Food and Drug Administration. The white paper discusses regulatory considerations for remote monitoring through digital health technologies to provide a framework for their use when evaluating safety or adverse events. It also provides practical recommendations and best practices on the implementation of these technologies into clinical trials through a scientific, technical, and operational lens. This manuscript does not constitute regulatory guidance.http://www.sciencedirect.com/science/article/pii/S2772963X25004843biomarkerclinical trialdigital healthregulatory scienceremote monitoringsafety |
| spellingShingle | Krishna Pundi, MD Sanjeev Bhavnani, MD Rosalyn Adigun, MD, PharmD Jose Vicente, PhD Rajesh Ghosh, MBA David Albert, MD Waqaas Al-Siddiq, DBA Charles Benson, MD, PhD Antoniu Fantana, PhD Jennifer C. Goldsack, MBA Salim F. Idriss, MD, PhD Gregory Marcus, MD, MAS Pamela Tenaerts, MD, MBA Mintu P. Turakhia, MD, MAS Jonathan Seltzer, MD, MBA Cardiovascular Sciences Research Consortium Think Tank JACC: Advances biomarker clinical trial digital health regulatory science remote monitoring safety |
| title | Cardiovascular Sciences Research Consortium Think Tank |
| title_full | Cardiovascular Sciences Research Consortium Think Tank |
| title_fullStr | Cardiovascular Sciences Research Consortium Think Tank |
| title_full_unstemmed | Cardiovascular Sciences Research Consortium Think Tank |
| title_short | Cardiovascular Sciences Research Consortium Think Tank |
| title_sort | cardiovascular sciences research consortium think tank |
| topic | biomarker clinical trial digital health regulatory science remote monitoring safety |
| url | http://www.sciencedirect.com/science/article/pii/S2772963X25004843 |
| work_keys_str_mv | AT krishnapundimd cardiovascularsciencesresearchconsortiumthinktank AT sanjeevbhavnanimd cardiovascularsciencesresearchconsortiumthinktank AT rosalynadigunmdpharmd cardiovascularsciencesresearchconsortiumthinktank AT josevicentephd cardiovascularsciencesresearchconsortiumthinktank AT rajeshghoshmba cardiovascularsciencesresearchconsortiumthinktank AT davidalbertmd cardiovascularsciencesresearchconsortiumthinktank AT waqaasalsiddiqdba cardiovascularsciencesresearchconsortiumthinktank AT charlesbensonmdphd cardiovascularsciencesresearchconsortiumthinktank AT antoniufantanaphd cardiovascularsciencesresearchconsortiumthinktank AT jennifercgoldsackmba cardiovascularsciencesresearchconsortiumthinktank AT salimfidrissmdphd cardiovascularsciencesresearchconsortiumthinktank AT gregorymarcusmdmas cardiovascularsciencesresearchconsortiumthinktank AT pamelatenaertsmdmba cardiovascularsciencesresearchconsortiumthinktank AT mintupturakhiamdmas cardiovascularsciencesresearchconsortiumthinktank AT jonathanseltzermdmba cardiovascularsciencesresearchconsortiumthinktank |