Planning Decentralized Trials

CTTI to Launch New Online Digital Health Trials Hub

Posted on by kristi.geercken@duke.edu

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 drives CTTI’s bold Transforming Trials 2030 vision by helping sponsors, investigators, CROs and technology providers design and run clinical trials that are patient-centered, easily accessible, and designed with a quality approach,” said CTTI Executive Director Sally Okun. 

The new Hub combines resources that have been restructured from CTTI’s four existing Digital Health Trials projects, completed from 2017 to 2019, along with improvements and new work from two project teams, Decentralized Clinical Trials Updates and Novel Endpoints Acceptance. By creating the Hub, CTTI’s aim is to make the most relevant information more useful and accessible for those in the clinical trials enterprise who are designing and running patient-centered trials. 

Key enhancements and additions made to the Hub include significantly updated recommendations, revised reference documents, and two new resources – the Question Bank for Identifying Meaningful Outcome Measures and a Process Map for use of a digitally-derived endpoint in an individual drug development pathway. These enhancements are the culmination of CTTI’s 2021 Digital Health Trials work that highlighted the importance of early stakeholder engagement, flexibility and tailored approaches to trial design and conduct, and flexible support of sites. 

The free one-hour webinar, which includes presentations from Megan Doyle of Amgen and Jörg Goldhahn of ETH Zurich, will begin at 11:00am EDT and registration is available online on CTTI’s website. 

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

Posted on by kristi.geercken@duke.edu

The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Aug. 25-26 to discuss best practices on conducting research in remote and virtual settings, including lessons learned from the COVID-19 pandemic. The insights gathered will be used to refresh CTTI’s 2018 Decentralized Clinical Trials (DCT) recommendations and ensure that they offer the most current information for planning and operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping).

During the meeting, relevant experts and key stakeholders—including investigators, patients, regulators, technology experts, sponsor representatives, and other groups—CTTI and attendees exchanged knowledge, insights, and current solutions for using DCT solutions in clinical trials.

They also identified some important themes and identified opportunities to increase adoption of DCT solutions moving forward:

  • Design with Purpose. The design of DCTs must prioritize patient safety and data quality. DCT elements should only be incorporated into study design where they are appropriate to the purpose of the study.
  • Engage Everyone. It’s important to engage all stakeholders in DCT protocol design and implementation.
  • Think Ahead, Early On. Careful planning and consideration from the earliest stages of study and program design is essential.
  • Invest in Quality. DCTs are often not the cheapest or easiest solution, but they can be the most impactful in terms of making trials more patient-centered and getting the best data.
  • Where to Focus Next. Communication, collaboration, and regulatory guidance are critical for broader adoption of DCT solutions.

CTTI is now updating its recommendations and will make them available by early 2022 to help accelerate the adoption of DCT solutions in clinical trials going forward.

Decentralized Clinical Trials Update Expert Meeting

AUGUST 25, 2021 TO AUGUST 26, 2021

CTTI Project: Supporting Decentralized Trial Approaches

Meeting Objectives:

In order to update CTTI’s existing decentralized clinical trials (DCT)* recommendations, this expert meeting aimed to:

  • Collect recent knowledge and insights – both what works and what doesn’t – from operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping)
  • Understand current practices for incorporating DCT solutions in clinical trials, including considerations for protocol design and safety monitoring
  • Identify opportunities to increase adoption of DCT solutions moving forward

*For the purposes of this meeting, DCTs were defined as those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).

Meeting Location:

Virtual Meeting

Meeting Agenda

Meeting Summary

List of Meeting Attendees

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Pre-Meeting Landscape Scan Results

Meeting Materials:

Day 1

Day 2

The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI Updates DCT Recommendations in Response to COVID-19

Posted on by kristi.geercken@duke.edu

COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized Clinical Trials (DCT) recommendations to ensure they reflect the latest learnings and emerging best practices from the pandemic.

CTTI’s current DCT recommendations, which launched in 2018 and focus on the use of telemedicine, mobile and local healthcare providers, and related topics, were the most frequently downloaded document on CTTI’s website in 2020, reflecting the increased demand for decentralized solutions in times of COVID-19.

This new project aims to support the accelerating adoption of DCT solutions in clinical trials going forward. The updated recommendations will focus on selecting and operationalizing DCT solutions, ensuring effective safety monitoring, and appreciating the needs and perspectives of investigators, sites, and participants.

This effort builds on CTTI’s initial recognition that running a DCT does not have to be all or nothing. DCTs can be completely virtual, but many will be partially decentralized using a hybrid approach. Regardless of where a trial falls on the decentralized continuum, it is always important to:

  • Plan ahead as much as possible
  • Involve all stakeholders early and often
  • Focus on what matters
  • Communicate and be transparent

Sponsors and CROs can use the revised recommendations to design a fit-for-purpose, efficient DCT—one that can reduce patient burden, improve enrollment, and more closely replicate real-world populations and scenarios.

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

Posted on by kristi.geercken@duke.edu

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 digital health trials.*

In-depth interviews conducted with 12 investigators representing an array of clinical specialties revealed the benefits and challenges of incorporating mobile technology into clinical trials through the use of smartphones, tablets, notebook computers, and wearable devices.

Some common benefits of digital health trials cited by the investigators include:

  • Streamlined study operations and data collection
  • Simplified and continuous study data capture throughout the trial
  • Improved study and data quality and an increase of “real-world” results

The manuscript also details specific challenges investigators faced when using digital health technologies in trials. These include an increase in the amount of time needed by investigators and study personnel to review data and maintain the technology, additional training, technology adoption barriers for participants and staff, and uncertainty with data validity. These potential obstacles must be proactively addressed in order to harness the full benefits of digital health trials.

Learn more about CTTI’s Digital Health Trials work.

*CTTI’s Digital Health Trials work was previously called “Mobile Clinical Trials”.