Original Digital Health Trials Projects

Topics Included: Data Collecting and Reporting, Innovative Trials, Regulatory Submissions + Approvals

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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

Project Team Members

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.

Resources

Site Planning | CTTI News

CTTI Leads Discussion on Digital Health Trials at ETH Digital Biomarkers Summit

In November 2024, Lindsay Kehoe, senior project manager at CTTI, presented at the Digital Biomarkers Summit held at ETH Zurich.

Regulatory Submissions + Approvals | CTTI News

Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials

A new CTTI publication, published in Nature Reviews Bioengineering, reviews opportunities for and challenges to using digital health technologies in clinical trials and highlights CTTI’s Digital Health Trials (DHTs) Hub....

Innovative Trials | CTTI News

Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub

A recording of CTTI’s April 6 public webinar introducing the new Digital Health Trials Hub is now available. The one-hour webinar includes presentations from Megan Doyle, Amgen, and Jörg Goldhahn,...

Innovative Trials | CTTI News

CTTI to Launch New Online Digital Health Trials Hub

CTTI will host a public webinar on Wed., Apr. 6 to introduce a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources. “This updated and expanded resource...

Regulatory Submissions + Approvals | CTTI News

CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials

Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in...

Regulatory Submissions + Approvals | CTTI News

CTTI Article Sheds Light on Participants’ Views of Mobile Clinical Trials

While adoption of mobile technologies presents many opportunities to enhance the quality and efficiency of clinical research, questions remain on patients’ preferences surrounding the use of mobile technologies in clinical...

Regulatory Submissions + Approvals | CTTI News

CTTI Unveils New Database of Feasibility Studies on Mobile Technologies in Clinical Research

Mobile technologies present exciting opportunities for researchers to monitor participants outside of the clinical setting. However, with new solutions entering the market daily, it can be challenging to decide which...

Regulatory Submissions + Approvals | CTTI News

Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials

A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led...

Regulatory Submissions + Approvals | CTTI News

CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain...

Regulatory Submissions + Approvals | CTTI News

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials. “Acceptance and...

Regulatory Submissions + Approvals | CTTI News

CTTI Examines Stakeholder Perceptions of Mobile Clinical Trials: Latest Expert Meeting Summary Now Available

The use of mobile technology holds the promise for higher quality, more efficient clinical trials, allowing remote participation in study activities, reducing patient burden, and facilitating the involvement of a...

Regulatory Submissions + Approvals | CTTI News

Finding Solutions to Legal and Regulatory Challenges of Conducting Mobile Clinical Trials

Mobile clinical trials (MCTs) offer several potential advantages, such as greater patient convenience, efficiencies in data collection, potential for novel endpoints, and enhanced participant retention. However, despite the successful conduct...

Regulatory Submissions + Approvals | CTTI News

CTTI Update: Advancing the Use of Mobile Health Technology to Transform Clinical Trials

Mobile technology has the potential to revolutionize clinical trials, but putting mobile clinical trials (MCTs) into action requires consideration of issues such as data integrity, legal and regulatory barriers, scientific...

Regulatory Submissions + Approvals | CTTI News

CTTI Advances Mobile Clinical Trials at DPharm 2017

Mobile technology has been used in a variety of ways, but it has yet to be widely incorporated into clinical trials—despite its great potential to increase trial quality and efficiency....

Regulatory Submissions + Approvals | CTTI News

Addressing Challenges of Using Mobile Devices in Clinical Trials

Mobile devices hold great potential to transform clinical trials by their ability to capture objective, real-world health data directly from study participants. While this technology shows promise to improve the...

Regulatory Submissions + Approvals | CTTI News

CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations

New CTTI Recommendations and Tools Equip Stakeholders to Integrate Mobile Technology into Clinical Trials Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data...

Regulatory Submissions + Approvals | CTTI News

Accelerating the Use of Mobile Technology In Clinical Trials: Webinar Recording Now Available

EXPERTS UNVEIL NEW RECOMMENDATIONS AND TOOLS FOR INTEGRATING NOVEL ENDPOINTS DERIVED FROM MOBILE TECHNOLOGY INTO CLINICAL TRIALS Mobile technologies are reshaping the landscape of clinical trials and making it possible to capture...

Regulatory Submissions + Approvals | CTTI News

Webinar June 26: Launching New CTTI Recommendations to Accelerate the Appropriate Use of Mobile Technology in Clinical Trials

Mobile technologies offer unique opportunities for making clinical trials faster, more efficient, and more representative of actual patient experiences. By addressing unmet needs for quality outcome measures, enabling more efficient...

Innovative Trials | CTTI News

CTTI

Clinical Trials Transformation Initiative

Original Digital Health Trials Projects

Original Digital Health Trials Projects

Resources

CTTI Leads Discussion on Digital Health Trials at ETH Digital Biomarkers Summit

Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials

Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub

CTTI to Launch New Online Digital Health Trials Hub

CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials

CTTI Article Sheds Light on Participants’ Views of Mobile Clinical Trials

CTTI Unveils New Database of Feasibility Studies on Mobile Technologies in Clinical Research

Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials

CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

CTTI Examines Stakeholder Perceptions of Mobile Clinical Trials: Latest Expert Meeting Summary Now Available

Finding Solutions to Legal and Regulatory Challenges of Conducting Mobile Clinical Trials

CTTI Update: Advancing the Use of Mobile Health Technology to Transform Clinical Trials

CTTI Advances Mobile Clinical Trials at DPharm 2017

Addressing Challenges of Using Mobile Devices in Clinical Trials

CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations

Accelerating the Use of Mobile Technology In Clinical Trials: Webinar Recording Now Available

Webinar June 26: Launching New CTTI Recommendations to Accelerate the Appropriate Use of Mobile Technology in Clinical Trials

Update on CTTI’s Mobile Devices Project: Webinar Recording Now Available

Expert Meeting Materials Now Available: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical

CTTI Program to Increase Adoption of Mobile Clinical Trials

CTTI’s Mobile Clinical Trials Program is Recognized as Advancing Clinical Trials in The Guardian

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