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 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. 

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the benefits of these methods, their use is still not widely accepted among sponsors, investigators, and regulators. Recently, there has been growing interest across the clinical trials ecosystem in advancing the use of disease progression modeling to improve clinical trial quality and efficiency and inform regulatory decision making. Disease progression modeling leverages data from a variety of sources, improving trial diversity and combining many different models to help inform decision making. 

To promote these methods, CTTI has started a new project engaging a variety of stakeholders and experts in the development of recommendations and resources for the application of disease progression modeling in clinical trials. Through this project, CTTI will generate case studies detailing successful applications of disease progression modeling, a framework for the execution of disease progression modeling in clinical trials, a set of recommendations for the implementation of disease progression modeling in clinical trials, and a review paper detailing relevant disease progression modeling applications. This project aims to improve trial and clinical development efficiency by increasing the recognition, value, and consistent use of disease progression modeling. CTTI’s work in this area will also help to advance the broader application of modeling and simulation for trial design and regulatory decision making. 

To generate recommendations and resources supporting the application of disease progression modeling in clinical trials, CTTI will utilize a variety of iterative evidence generating strategies—including a scoping review assessing the landscape of disease progression modeling applications and an expert meeting discussing the barriers to disease progression modeling application and avenues for advancement. 

Through this work, CTTI will create recommendations and resources for designing clinical trials with a quality approach that maximally leverages available data—in alignment with CTTI’s Transforming Trials 2030 vision.

 

Using Disease Progression Modeling to Advance Trial Design and Decision Making

Topics Included: Innovative Trials, Regulatory Submissions + Approvals

Using modeling and simulations, researchers can make more informed decisions when planning and executing clinical trials. In particular, disease progression modeling (DPM) leverages multiple types of data from various sources to inform trial design and support regulatory decision making. To help advance the use of DPM in medical product development, CTTI has released recommendations that highlight its unique value and provide practical guidance on when and how to apply it effectively. These resources support efforts to bring treatments to patients more efficiently and promote broader adoption of modeling and simulation approaches in clinical research.

Resources

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

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the...

Regulatory Submissions + Approvals

Using Disease Progression Modeling to Advance Trial Design and Decision Making

Using modeling and simulations, researchers can make informed decisions when planning and executing clinical trials. In particular, disease progression modeling leverages multiple types of data from various sources to inform...

Site Planning | CTTI News

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

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...

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Innovative Trials | CTTI News

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication...

Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...

Regulatory Submissions + Approvals

Developing Novel Endpoints

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Innovative Trials

Selecting and Testing a Digital Health Technology

There are many digital health technologies in the marketplace—how do you choose the best one for your trial? And after you’ve selected the candidate technology for your trial, how do...

Formats

Stage of Trial

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

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.

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap, CTTI held an “Obtaining Novel Endpoint Reliability & Acceptance” Expert Meeting on July 27-28 to inform its new recommendations and resources for driving novel endpoint acceptance.

Attendees discussed challenges and potential solutions to advancing the practical use of novel, digitally derived endpoints in clinical trials. They also uncovered and agreed on some important common themes:

  • The Time is Now. Digitally derived endpoints have the ability to capture information that is more reflective of how patients feel and function in their day-to-day lives – but many factors hinder their acceptance. Collaborative partnerships and solutions that increase the understanding and use of DHT-derived endpoints are needed to make this happen.
  • Fit-for-Purpose is a Must. DHT-derived endpoints need to be based on the specific context of use and validly measure a concept of interest in a way that is accurate, interpretable, and not misleading.
  • “Meaningful” in More than One Way. To develop a DHT-derived endpoint, have the community – including patients and clinicians – discuss what constitutes “meaningful” change. A meaningful measure should show treatment benefit as well as clinical benefit.
  • Engage Early and Often. Engage patients, investigative site personnel, and the FDA early and often when planning; involve biostatisticians and data scientists, as appropriate, in decisions regarding protocol design, data collection, analysis, and interpretation
  • Validate, Validate, Validate. It’s important to remember that validating a device is a separate, yet parallel, process from validating the clinical measure. It is also especially important to demonstrate analytical validation of DHT algorithms within the specific patient populations.

This meeting and its findings, part of CTTI’s Novel Endpoint Acceptance project, will help expand CTTI’s 2017 Novel Endpoint work, which produced a set of recommendations, flowchart, detailed steps, and many other resources for developing novel endpoints.

For a preview of CTTI’s expanded set of novel endpoints recommendations and resources, register to attend its Oct. 5 “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” webinar.

Clinical Trials Issues Related to COVID-19

Topics Included: Access to Clinical Trials, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals

Overview

The COVID-19 pandemic caused unprecedented disruptions to nearly every aspect of clinical research.

To help, CTTI led several efforts -- including conducting surveys, holding webinars, and developing resources -- with the goal of helping the clinical trials ecosystem adapt and move forward during the pandemic, including:

Resources

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

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the...

Regulatory Submissions + Approvals

Using Disease Progression Modeling to Advance Trial Design and Decision Making

Using modeling and simulations, researchers can make informed decisions when planning and executing clinical trials. In particular, disease progression modeling leverages multiple types of data from various sources to inform...

Site Planning | CTTI News

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

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...

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Innovative Trials | CTTI News

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication...

Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...

Regulatory Submissions + Approvals

Developing Novel Endpoints

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Innovative Trials

Selecting and Testing a Digital Health Technology

There are many digital health technologies in the marketplace—how do you choose the best one for your trial? And after you’ve selected the candidate technology for your trial, how do...

Formats

Stage of Trial

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication of activities that already occur in clinical care. However, there are currently no guidelines or strategies to help clinical trial stakeholders operationalize this fit-for-purpose integration.

To remedy this issue, CTTI is starting work on a new project that will result in data, resources, and recommendations aimed at bridging the gap between trials and clinical care settings to improve evidence generation. This project aims to:

  • Identify when elements of interventional clinical trial integration into clinical settings would be feasible and the associated benefits and risks
  • Identify barriers and potential solutions to incorporating interventional trials into clinical care
  • Describe operational approaches to incorporating interventional trials into clinical care

CTTI will develop the new recommendations by conducting in-depth interviews that identify barriers and solutions with a wide variety of clinical trial and healthcare experts, compiling case studies on innovative operational approaches, and organizing a multi-stakeholder meeting to discuss strategies.

By taking a multifaceted approach, CTTI aims to create resources that will help clinical trial stakeholders overcome the barriers to integrating interventional research into real-world settings to create more relevant results.

Planning Decentralized Trials

Topics Included: Ensuring Quality, Innovative Trials, Patient Engagement, Site Planning

Program: Digital Health Trials

Related Projects: Developing Novel Endpoints, Selecting & Testing a Digital Health Technology, Managing Data, Supporting Sites, Interacting with Regulators

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially decentralized with hybrid approaches, or very similar to traditional “brick and mortar” trials.

Regardless of where your trial is on the decentralized spectrum, CTTI's recommendations can help you plan and conduct a successful trial.

Resources

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

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the...

Regulatory Submissions + Approvals

Using Disease Progression Modeling to Advance Trial Design and Decision Making

Using modeling and simulations, researchers can make informed decisions when planning and executing clinical trials. In particular, disease progression modeling leverages multiple types of data from various sources to inform...

Site Planning | CTTI News

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

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...

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Innovative Trials | CTTI News

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication...

Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...

Regulatory Submissions + Approvals

Developing Novel Endpoints

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Innovative Trials

Selecting and Testing a Digital Health Technology

There are many digital health technologies in the marketplace—how do you choose the best one for your trial? And after you’ve selected the candidate technology for your trial, how do...

Formats

Stage of Trial

Developing Novel Endpoints

Topics Included: Innovative Trials, Regulatory Submissions + Approvals

Program: Digital Health Trials

Related Projects: Planning Decentralized Trials, Selecting & Testing a Digital Health Technology, Managing Data, Supporting Sites, Interacting with Regulators

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Using these recommendations and resources, you can develop novel endpoints that more accurately represent the patient experience and, therefore, may be more meaningful to patients, providers, and others.

Resources

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

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the...

Regulatory Submissions + Approvals

Using Disease Progression Modeling to Advance Trial Design and Decision Making

Using modeling and simulations, researchers can make informed decisions when planning and executing clinical trials. In particular, disease progression modeling leverages multiple types of data from various sources to inform...

Site Planning | CTTI News

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

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...

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Innovative Trials | CTTI News

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication...

Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...

Regulatory Submissions + Approvals

Developing Novel Endpoints

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Innovative Trials

Selecting and Testing a Digital Health Technology

There are many digital health technologies in the marketplace—how do you choose the best one for your trial? And after you’ve selected the candidate technology for your trial, how do...

Formats

Stage of Trial

Selecting and Testing a Digital Health Technology

There are many digital health technologies in the marketplace—how do you choose the best one for your trial? And after you’ve selected the candidate technology for your trial, how do you prepare it for use in the field?

CTTI’s recommendations and resources will help you understand what needs to be considered before selecting a digital health technology and walk you through the feasibility testing, verification, and validation processes.

Resources

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

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the...

Regulatory Submissions + Approvals

Using Disease Progression Modeling to Advance Trial Design and Decision Making

Using modeling and simulations, researchers can make informed decisions when planning and executing clinical trials. In particular, disease progression modeling leverages multiple types of data from various sources to inform...

Site Planning | CTTI News

CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

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...

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Innovative Trials | CTTI News

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication...

Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...

Regulatory Submissions + Approvals

Developing Novel Endpoints

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Innovative Trials

Selecting and Testing a Digital Health Technology

There are many digital health technologies in the marketplace—how do you choose the best one for your trial? And after you’ve selected the candidate technology for your trial, how do...

Formats

Stage of Trial