CTTI Archives - Rethinking Clinical Trials

July 15, 2025: ClinicalTrials.gov and the State of Clinical Trials, in This Week’s Rethinking Clinical Trials Grand Rounds

Posted on July 14, 2025July 15, 2025 by Damon Seils

Headshots of Adrian Hernandez and Rebecca Sullenger — Adrian Hernandez and Rebecca Sullenger

In this Friday’s Rethinking Clinical Trials Grand Rounds, Adrian Hernandez and Rebecca Sullenger of Duke University will present “State of Clinical Trials: An Analysis of ClinicalTrials.gov.”

They will be joined by a discussion panel that will include Sara Bristol Calvert of the Clinical Trials Transformation Initiative (CTTI) and Karen Chiswell and Christopher J. Lindsell of Duke University.

The Grand Rounds session will be held on Friday, July 18, 2025, at 1:00 pm eastern.

Hernandez, who serves as co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center, is a professor of medicine and vice dean in the Duke University School of Medicine and executive director of the Duke Clinical Research Institute (DCRI). Sullenger is an MD student in the Duke University School of Medicine. Calvert is director of projects at CTTI, Chiswell is a statistical scientist at the DCRI, and Lindsell is the director of data science and biostatistics at the DCRI.

Join the online meeting.

Grand Rounds September 30, 2022: CTTI’s Digital Health Trials Hub Recommendations and Resources to Run Your Digital Health Trial (Marianne Chase, MGH, CTTI Team Lead, Jörg Goldhahn, ETH Zurich, CTTI Team Lead)

Posted on October 4, 2022September 25, 2025 by terren.green@duke.edu

Speakers

Marianne Chase
Senior Director Clinical Trial Operations
Neurological Clinical Research Institute
Massachusetts General Hospital

Jörg Goldhahn, MD
Medical Director
Director of Institute for Translational Medicine
ETH Zurich

Keywords

Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints

Key Points

The Clinical Trial Transformation Initiative (CTTI) envisions an evidence generating system with trials that are patient-centered, integrated into health processes, quality, leverage all available data, and improve population health.

Digital Health Trials can help research obtain better and more reliable information, conduct more patient-centric research, and move at higher speed and efficiency. We need to work together to find ways to evaluate the potential benefits and share lessons learned broadly.

CTTI’s Decentralized Clinical Trials Project was a 1 year accelerated project to deliver updated recommendations and best practices for Decentralized Clinical Trials (DCTs).

DCTs range from near-traditional to hybrid to fully remote trials that conduct study visits away from the central study site using strategies such as tele-visits or home delivery of investigational products.

Decentralized trials require novel technology and digital endpoints. CTTI wants to increase meaningful novel digital endpoints that are clinically relevant and fit-for-purpose.

CTTI has developed 35 tools to help study teams develop meaningful measures, map individual medical product development, navigate regulatory requirements, and help implement other CTTI recommendations.

Discussion Themes

– One of the key challenges in the field of decentralized trials and digital measures is sharing tools and collaboration between companies. There’s a growing understanding that we have to collaborate on the endpoints and digital technology to advance the field.

– A feasibility study is a good way to gain insight into possible snags when participants may not be tech savvy. Tech support at the site level is important to addressing problems in a study.

Read more about the Clinical Trial Transformation Initiative and CTTI’s vision for clinical trials in 2030. Find CTTI’s recommendations and resources.

Tags

#pctGR, @Collaboratory1

September 28, 2022: PCT Grand Rounds to Feature CTTI’s Digital Health Trials Hub

Posted on September 28, 2022September 28, 2022 by Damon Seils

Headshots of Marianne Chase and Dr. Jörg Goldhahn In this Friday’s PCT Grand Rounds, Marianne Chase of Massachusetts General Hospital and Dr. Jörg Goldhahn of ETH Zurich will present “CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials.” The Grand Rounds session will be held on Friday, September 30, 2022, at 1:00 pm eastern.

Chase is senior director for clinical trial operations at Mass General’s Neurological Clinical Research Institute. Goldhahn is medical director of the Institute for Translational Medicine at ETH Zurich.

Join the online meeting.

January 15, 2021: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic (Pamela Tenaerts, MD, MBA; Sara Calvert, PharmD; Leanne Madre, JD, MHA)

Posted on January 20, 2021September 25, 2025 by Gina Uhlenbrauck

Speakers

Pamela Tenaerts, MD, MBA
Executive Director
Clinical Trials Transformation Initiative

Sara Calvert, PharmD
Senior Project Manager
Clinical Trials Transformation Initiative

Leanne Madre, JD, MHA
Directory of Strategy
Clinical Trials Transformation Initiative

Topic

How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic

Keywords

Clinical Trials Transformation Initiative (CTTI); Best practices; COVID-19 treatment trials; RECOVERY Trial; Digital health technology; Decentralized clinical trials

Key Points

During 2020, CTTI conducted a series of intensive surveys, discussions, and collaborations across the clinical trials ecosystem, which shaped the creation of public webinars, a Best Practices for Conducting Trials During the COVID-19 Pandemic playbook, and a searchable, real-time AACT COVID-19 Trials Spreadsheet, among other efforts.
CTTI’s efforts helped the research community successfully navigate the challenges associated with adjusting trials that were underway when the pandemic hit, as well as launching new trials for COVID-19 treatments.
Among the best practices for conducting clinical trials during the pandemic: keep participants informed, perform ongoing risk-benefit assessment, adjust study startup and enrollment based on current risks, pivot to remote study visits, and switch to remote monitoring.

Discussion Themes

Because of the COVID-19 pandemic, there is more momentum toward digital health technology and decentralized clinical trials.

With the pandemic, we are seeing trial results go straight to practice, bypassing input from the clinical community at large—will this continue after the pandemic?

To what extent do you think the IRB/research oversight sphere might be permanently reshaped by the pandemic’s impact on the conduct of clinical trials?

Tags

#pctGR, @Collaboratory1

January 14, 2021: NIH Collaboratory COVID-19 Grand Rounds Continues With Clinical Trials Challenges in the COVID-19 Pandemic

Posted on January 14, 2021January 14, 2021 by Damon Seils

In this week’s COVID-19 Grand Rounds session, Dr. Pamela Tenaerts of the Clinical Trials Transformation Initiative will present “How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic.” The Grand Rounds session will be held on Friday, January 15, at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Grand Rounds January 15: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic

Speaker:

Pamela Tenaerts, MD, MBA
Executive Director
Clinical Trials Transformation Initiative

Topic: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic
Date: Friday, January 15, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m60b64f1826bed9d8f0b16c759c4fdcb0

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 120 398 9257
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 398 9257

NOTE: For Toll-free users, the call-back (call me) services are also available.

February 15, 2019: Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative (Christine M. Hildebrand, PA-C, Janette Panhuis)

Posted on February 19, 2019 by Gina Uhlenbrauck

Speakers

Christine M. Hildebrand, PA-C
Physician Assistant
Sub-Investigator
Clinical Operations Lead
Amici Clinical Research

Janette Panhuis
Chief Operating Officer
Population Health Research Institute
David Braley Research Institute

Topic

Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative

Keywords

CTTI; Investigator qualifications; Investigator training; Site team training; Good clinical practice; Clinical trials

Key Points

There is little evidence that good clinical practice (GCP) training alone sufficiently qualifies investigators in the conduct of clinical trials. What is needed is a targeted and risk-based approach to educating clinical trial investigators and their delegates in GCP principles.
A culture shift is needed that eliminates the distinction between “qualification” and “preparation” and moves toward investigators and their delegates assuming greater ownership of training and documenting evidence of their qualification.
CTTI recommendations outline how to confirm that site teams are qualified while also reducing inefficiencies in training and increasing preparation for successful study execution.

Discussion Themes

Investigators and site teams come to the table with different levels of research experience, training, and credentials. How can we effectively address gaps in skills and knowledge of GCP principles?

With respect to pragmatic trials conducted within healthcare systems, are there approaches to site monitoring that address issues related to turnover of PIs and clinical and research staff?

Greater ownership of GCP training and qualification by investigators and delegates can lead to active remediation of deficiencies at the clinical site.

CTTI recommendations are meant to be adaptable to the protocol, even when conducted in a real-world clinical setting using electronic health records.

For recommendations and tools for improving investigator qualification, visit CTTI’s Investigator Qualification website.

Tags

#ClinicalTrials, #GCPtraining, #pctGR, @Collaboratory1 @CTTI_Trials

October 19, 2018: A New Path Forward for Using Decentralized Clinical Trials (Jeffry Florian, PhD, Annemarie Forrest, Penny Randall, MD, MBA)

Posted on October 22, 2018 by Gina Uhlenbrauck

Speakers

Jeffry Florian, PhD
Clinical Analyst, Office of New Drugs
FDA Center for Drug Evaluation and Research (CDER)

Annemarie Forrest
Clinical Trials Transformation Initiative (CTTI)

Penny Randall, MD, MBA
VP and Global Therapeutic Head, CNS
IQVIA

Topic

A New Path Forward for Using Decentralized Clinical Trials

Keywords

Decentralized clinical trials; Telemedicine; Mobile health; Clinical Trials Transformation Initiative; FDA

Key Points

Decentralized clinical trials (DCTs) are defined as those executed through telemedicine, mobile, or local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model; for example, shipping investigational medical product directly to the trial participant.
DCTs are not “all or nothing.” They exist in a broad continuum and can expand the reach of traditional clinical trial sites.
Potential benefits of DCTs apply to all trials in all disease areas but may offer particular advantages in rare diseases, where patients are generally limited in number or are highly geographically dispersed.
Mobile HCP training is similar to that required for standard investigative sites: Good clinical practice, protocol-specific training, human subject protections, data protection, and clinical trial billing.

Discussion Themes

Will a decentralized trial lead to less diverse patient populations as participants will need to be technology literate and have access to technology?

Decentralized clinical trial safety monitoring plans should not be held to a higher standard than with traditional trials unless merited by a particular circumstance. It is important to develop protocol-specific safety monitoring and communication escalation plans.

Download CTTI’s recommendations for decentralized clinical trials.

Tags

#telemedicine #pctGR, @PCTGrandRounds, @Collaboratory1, @CTTI_Trials @IQVIA_global @US_FDA

September 14, 2018: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials (John Hubbard, PhD, Barry Peterson, PhD, Cheryl Grandinetti, PharmD)

Posted on September 17, 2018July 9, 2025 by Gina Uhlenbrauck

Speakers

John Hubbard, PhD
Healthcare Strategic Advisory Board
Genstar Capital

Barry Peterson, PhD
Independent Consultant

Cheryl Grandinetti, PharmD
Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance Evaluation
Center for Drug Evaluation and Research
Food and Drug Administration

Topic

Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

Keywords

Clinical trials; Mobile health technologies; Clinical Trials Transformation Initiative; CTTI; FDA; Data integrity

Key Points

The goal of CTTI’s Mobile Clinical Trials program is to develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission.
Potential benefits of using mobile technology include higher quality, patient-centric endpoints and fewer barriers to participation in clinical trials.
Data access issues to consider before selecting a mobile technology include:
- How will the data generated by the mobile technology be accessed and used by the manufacturer?
- What data will be provided by the manufacturer to the sponsor?
The mobile era creates new data security demands.

Discussion Themes

CTTI’s recommendations aim to help sponsors determine the right device to use, how to write the protocol for remote data capture, and how to protect and analyze the data.

Know what you want to measure before selecting the mobile technology. The appropriateness of the selection should be justified through verification and validation processes.

Ensure the authenticity, integrity, and confidentiality of data over its entire lifecycle.

To reduce risk in large trials, conduct feasibility studies before full implementation.

Visit CTTI for more recommendations and resources for mobile clinical trials.

Tags

@CTTI_Trials, @PCTGrandRounds, #MobileTech, #pctGR