Overview
Throughout 2015-2019, CTTI worked in four key areas to identify and address the challenges of planning for and conducting FDA-regulated clinical trials that use digital health technologies:
- Novel Endpoints
- Digital Health Technologies
- Decentralized Clinical Trials
- Engaging Patients and Sites
Through this Digital Health Trials program, numerous organizations and individuals collaborated to create a suite of solutions that helped drive the evolution of the clinical trials to keep pace with technological innovations. Since then, as the landscape progressed and in light of COVID-19, CTTI repackaged its Digital Health Trials work into a refreshed, more practical, and easy-to-use format.
Original or complete materials not included in the repackaged section are hosted here for reference.
Novel Endpoints
Digital Health Technologies
Decentralized Clinical Trials
Engaging Patients and Sites
In Detail
Role | Name | Affiliation | Project |
---|---|---|---|
Project Manager | Jennifer Goldsack | Clinical Trials Transformation Initiative | Novel Endpoints |
EC Champion | John Alexander | Duke University | Novel Endpoints |
Social Science Lead | Brian Perry | Clinical Trials Transformation Initiative | Novel Endpoints |
Team Leader | Lauren Bataille | MJFF | Novel Endpoints |
Team Leader | Robert DiCicco | GSK | Novel Endpoints |
Team Leader | Cheryl Grandinetti | FDA/CDER | Novel Endpoints |
Team Leader | William Herrington | University of Oxford | Novel Endpoints |
Team Leader | Martin Landray | University of Oxford | Novel Endpoints |
Team Leader | Kaveeta Vasisht | FDA/OC | Novel Endpoints |
Team Member | Elektra Papadopoulos | FDA/CDER | Novel Endpoints |
Team Member | Ashish Narayan | Feinstein | Novel Endpoints |
Team Member | Nirav Sheth | MC10 | Novel Endpoints |
Team Member | Ken Skodacek | FDA/CDRH | Novel Endpoints |
Team Member | Komathi Stem | MonARCH Bionetworks | Novel Endpoints |
Team Member | Theresa Strong | FPWR | Novel Endpoints |
Team Member | Marc Walton | Johnson & Johnson/Janssen | Novel Endpoints |
Project Manager | Annemarie Forrest | Clinical Trials Transformation Initiative | Digital Health Technologies |
Social Science Lead | Amy Corneli | Clinical Trials Transformation Initiative | Digital Health Technologies |
EC Champion | John Hubbard | Bioclinica Inc | Digital Health Technologies |
Team Member | Marisa Bolognese | The Life Raft Group | Digital Health Technologies |
Team Member | Philip Coran | Medidata Solutions | Digital Health Technologies |
Team Member | Christopher Dell | Pfizer, Inc. | Digital Health Technologies |
Team Member | Ray Dorsey | University of Rochester | Digital Health Technologies |
Team Member | Cheryl Grandinetti | FDA/CDER | Digital Health Technologies |
Team Member | Kaveeta Vasisht | FDA/OC | Digital Health Technologies |
Team Member | Adam Amdur | ASAA | Digital Health Technologies |
Team Member | Jessie Bakker | Phillips Respironics | Digital Health Technologies |
Team Member | Aiden Doherty | University of Oxford | Digital Health Technologies |
Team Member | Jonathan Helfgott | Johns Hopkins University | Digital Health Technologies |
Team Member | Matthew Kirchoff | NIH | Digital Health Technologies |
Team Member | Phillip Kronstein | FDA/CDER | Digital Health Technologies |
Team Member | Christopher Miller | AstraZeneca Pharmaceuticals LP | Digital Health Technologies |
Team Member | Ashish Narayan | Mt Sinai Health System | Digital Health Technologies |
Team Member | Dharmesh Patel | FDA/CDRH | Digital Health Technologies |
Team Member | Barry Peterson | Phillips Respironics | Digital Health Technologies |
Team Member | Ernesto Ramirez | Fitabase | Digital Health Technologies |
Team Member | Drew Schiller | Validic | Digital Health Technologies |
Team Member | Tom Switzer | Genentech-a member of the Roche Group | Digital Health Technologies |
Recommendations Advisory Committee | Riaz Bandali | Syneos Health | Digital Health Technologies |
Recommendations Advisory Committee | Sheila Brown | FDA/OC | Digital Health Technologies |
Recommendations Advisory Committee | Yan Chow | Amgen Inc | Digital Health Technologies |
Recommendations Advisory Committee | Harold Collard | University of California, San Francisco | Digital Health Technologies |
Recommendations Advisory Committee | Alan Frederickson | IQVIA | Digital Health Technologies |
Recommendations Advisory Committee | Daniel Grant | Novartis | Digital Health Technologies |
Recommendations Advisory Committee | Matthew Heasley | GSK | Digital Health Technologies |
Recommendations Advisory Committee | Cynthia Kleppinger | FDA/CDER | Digital Health Technologies |
Recommendations Advisory Committee | Seleen Ong | Pfizer, Inc. | Digital Health Technologies |
Recommendations Advisory Committee | Linda Ricci | FDA/CDRH | Digital Health Technologies |
Recommendations Advisory Committee | Daniel Rose | PFF | Digital Health Technologies |
Recommendations Advisory Committee | Michele Russell-Einhorn | Advarra | Digital Health Technologies |
Recommendations Advisory Committee | David Schneider | Syneos Health | Digital Health Technologies |
Recommendations Advisory Committee | William Wood | UNC NC TraCS | Digital Health Technologies |
Recommendations Advisory Committee | Jeremy Wyatt | ActiGraph | Digital Health Technologies |
Project Manager | Lindsay Kehoe | Clinical Trials Transformation Initiative | Decentralized Clinical Trials |
Social Science Lead | Amy Corneli | Clinical Trials Transformation Initiative | Decentralized Clinical Trials |
Team Leader | Linda Coleman | Yale University | Decentralized Clinical Trials |
Team Leader | Gary Grabow | Genentech-a member of the Roche Group | Decentralized Clinical Trials |
Team Leader | Jan Hewett | FDA/CDER | Decentralized Clinical Trials |
Team Leader | Barak Richman | Duke University | Decentralized Clinical Trials |
Team Member | David Babaian | Quorum Review IRB | Decentralized Clinical Trials |
Team Member | Mark Borigini | FDA/CDER | Decentralized Clinical Trials |
Team Member | Matthew Bryant | Amgen Inc | Decentralized Clinical Trials |
Team Member | Paul Conway | American Association of Kidney Patients | Decentralized Clinical Trials |
Team Member | Kristin Dolinski | PhRMA | Decentralized Clinical Trials |
Team Member | Jeffry Florian | FDA/CDER | Decentralized Clinical Trials |
Team Member | Amy Hummel | Yale University | Decentralized Clinical Trials |
Team Member | Gracie Lieberman | Genentech-a member of the Roche Group | Decentralized Clinical Trials |
Team Member | Kristen Miller | FDA/CDER | Decentralized Clinical Trials |
Team Member | Laura Podolsky | Science37 | Decentralized Clinical Trials |
Team Member | Vaishali Popat | FDA/CDER | Decentralized Clinical Trials |
Team Member | Penny Randall | IQVIA | Decentralized Clinical Trials |
Team Member | Ken Skodacek | FDA/CDRH | Decentralized Clinical Trials |
Team Member | Marissa Stroo | Duke University | Decentralized Clinical Trials |
Project Manager | Zachary Hallinan | Clinical Trials Transformation Initiative | Engaging Patients and Sites |
Social Science Lead | Amy Corneli | Clinical Trials Transformation Initiative | Engaging Patients and Sites |
EC Champion | Virginia Nido | Genentech-a member of the Roche Group | Engaging Patients and Sites |
Team Leader | Cynthia Geoghegan | Individual Patient/Caregiver | Engaging Patients and Sites |
Team Leader | Steve Morin | FDA/OC | Engaging Patients and Sites |
Team Leader | Virginia Nido | Individual Patient/Caregiver | Engaging Patients and Sites |
Team Leader | William Wood | UNC NC TraCS | Engaging Patients and Sites |
Team Member | Maria Ali | The George Institute | Engaging Patients and Sites |
Team Member | David Borasky | WCG | Engaging Patients and Sites |
Team Member | Angie Botto-van Bemden | Individual Consultant | Engaging Patients and Sites |
Team Member | Sue Dubman | Individual Patient/Caregiver | Engaging Patients and Sites |
Team Member | Les Jordan | Target Health, LLC | Engaging Patients and Sites |
Team Member | Hassan Kadhim | Boehringer Ingelheim | Engaging Patients and Sites |
Team Member | Amanda Niskar | Individual Patient/Caregiver | Engaging Patients and Sites |
Team Member | Paul O'Donohoe | Medidata Solutions | Engaging Patients and Sites |
Team Member | Petros Okubagzi | MedStar Health | Engaging Patients and Sites |
Team Member | Ido Paz-Priel | Genentech-a member of the Roche Group | Engaging Patients and Sites |
Team Member | Ken Skodacek | FDA/CDRH | Engaging Patients and Sites |
Team Member | Junyang Wang | FDA/CDER | Engaging Patients and Sites |
Recommendations Advisory Committee | Matthew Bryant | Amgen Inc | Engaging Patients and Sites |
Recommendations Advisory Committee | Anthony Costello | Medidata Solutions | Engaging Patients and Sites |
Recommendations Advisory Committee | Karen Erickson | Alpha-1 Foundation | Engaging Patients and Sites |
Recommendations Advisory Committee | Elisha French | Genentech-a member of the Roche Group | Engaging Patients and Sites |
Recommendations Advisory Committee | John Hixson | VA | Engaging Patients and Sites |
Recommendations Advisory Committee | Daniel Karlin | Pfizer, Inc. | Engaging Patients and Sites |
Recommendations Advisory Committee | Megan Oakes | Duke University | Engaging Patients and Sites |
Recommendations Advisory Committee | Bola Oyegunwa | IQVIA | Engaging Patients and Sites |
Recommendations Advisory Committee | Penny Randall | IQVIA | Engaging Patients and Sites |
Recommendations Advisory Committee | Michele Russell-Einhorn | Advarra | Engaging Patients and Sites |
Recommendations Advisory Committee | Nirmish Shah | Duke University | Engaging Patients and Sites |
Recommendations Advisory Committee | Angela Walker | Lilly | Engaging Patients and Sites |
Recommendations Advisory Committee | Rob Wilson | ActiGraph | Engaging Patients and Sites |
Project Manager | Lindsay Kehoe | Clinical Trials Transformation Initiative | Feasibility Studies |
Team Member | Jessie Bakker | Philips Respironics | Feasibility Studies |
Team Member | Michael Clarke | Queen's | Feasibility Studies |
Team Member | Andy Coravos | Elektra Labs | Feasibility Studies |
Team Member | Cynthia Geoghegan | Individual Patient/Caregiver | Feasibility Studies |
Team Member | Alan Godfrey | Northumbria University | Feasibility Studies |
Team Member | Jennifer Goldsack | DiMe | Feasibility Studies |
Team Member | Matthew Heasley | GSK | Feasibility Studies |
Team Member | Christine Manta | Duke University | Feasibility Studies |
Team Member | Caroline Marra | Harvard University | Feasibility Studies |
Team Member | Ernesto Ramirez | Evidation Health | Feasibility Studies |
Team Member | Nirav Sheth | MicroMedicine | Feasibility Studies |
Team Member | William Wood | UNC NC TraCS | Feasibility Studies |
Organization affiliations are listed as active affiliations during the project.
*Indicates former project manager, team leader, or team member.