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 | Publications

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Innovative Trials | Case Studies

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI’s Recommendations Work

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI's Recommendations WorkWhere to Begin with Digital Health Technologies?

Regulatory Submissions + Approvals | Case Studies

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

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...

Innovative Trials

Managing Data

Digital health technologies have fundamentally changed when, where, and how data can be collected.

Innovative Trials | CTTI News

CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials

Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to...

Innovative Trials | CTTI News

New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can...

Regulatory Submissions + Approvals | Resources

CTTI Novel Endpoints Interactive Selection Tool

CTTI Novel Endpoints Interactive Selection Tool

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 | Publications

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Innovative Trials | Case Studies

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI’s Recommendations Work

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI's Recommendations WorkWhere to Begin with Digital Health Technologies?

Regulatory Submissions + Approvals | Case Studies

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

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...

Innovative Trials

Managing Data

Digital health technologies have fundamentally changed when, where, and how data can be collected.

Innovative Trials | CTTI News

CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials

Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to...

Innovative Trials | CTTI News

New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can...

Regulatory Submissions + Approvals | Resources

CTTI Novel Endpoints Interactive Selection Tool

CTTI Novel Endpoints Interactive Selection Tool

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 | Publications

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Innovative Trials | Case Studies

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI’s Recommendations Work

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI's Recommendations WorkWhere to Begin with Digital Health Technologies?

Regulatory Submissions + Approvals | Case Studies

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

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...

Innovative Trials

Managing Data

Digital health technologies have fundamentally changed when, where, and how data can be collected.

Innovative Trials | CTTI News

CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials

Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to...

Innovative Trials | CTTI News

New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can...

Regulatory Submissions + Approvals | Resources

CTTI Novel Endpoints Interactive Selection Tool

CTTI Novel Endpoints Interactive Selection Tool

Formats

Stage of Trial

Managing Data

Digital health technologies have fundamentally changed when, where, and how data can be collected. Yet the critical principle of data collection remains the same: ensuring the authenticity, integrity, and confidentiality of data over time.

Use CTTI’s recommendations and resources to help understand, plan for, and address the challenges associated with digital health technologies, including data access, ownership, sharing, and storage, as well as communicating trial data with participants.

Resources

Innovative Trials | Publications

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Innovative Trials | Case Studies

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI’s Recommendations Work

Where to Begin with Digital Health Technologies? A Digital Health Scientist with Genentech Explains How CTTI's Recommendations WorkWhere to Begin with Digital Health Technologies?

Regulatory Submissions + Approvals | Case Studies

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

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...

Innovative Trials

Managing Data

Digital health technologies have fundamentally changed when, where, and how data can be collected.

Innovative Trials | CTTI News

CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials

Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to...

Innovative Trials | CTTI News

New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can...

Regulatory Submissions + Approvals | Resources

CTTI Novel Endpoints Interactive Selection Tool

CTTI Novel Endpoints Interactive Selection Tool

Formats

Stage of Trial

CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials

Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to unlocking these benefits is to ensure that patient and site perspectives are considered during the planning process. CTTI has released a new manuscript in Contemporary Clinical Trials Communications that features the first evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials.

CTTI’s comprehensive recommendations for planning trials using digital health technologies offer advice across several research study topics, including:

  • Engaging patients and sites in planning clinical trials using digital health technology
  • Maximizing value and minimizing burden for study participants
  • Addressing challenges for investigative sites

This comprehensive set of recommendations was developed by first conducting a survey of 193 potential research participants regarding their willingness to use digital health technology in clinical trials as well as their preferences and concerns. Site experiences and preferences were captured through qualitative interviews with 12 different investigators. CTTI then collated this information and conducted an expert meeting over two days. Attendees, including patients, investigators, regulators, sponsors, and technology experts, presented key findings and discussed strategies and implications.

Because patients and site personnel offer important perspectives on how best to incorporate digital health technology into a trial, CTTI recommends their input be taken into account early and often. Ensuring their engagement helps stakeholders incorporate digital health technologies in the most efficient way possible, which can help to advance clinical trials and accelerate the development of new treatment options.

Read the full manuscript.

New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can support regulatory labeling claims.

To address this issue, CTTI is conducting a new project that will build on previous novel endpoint work to create additional resources and recommendations to drive the use of digitally derived, functional outcomes as key endpoints in clinical trials to support regulatory decision-making.

Once the project is complete, stakeholders can look forward to resources such as:

  • Best practice recommendations on the “standards of evidence” needed to qualify a DHT-derived novel endpoint
  • Glossary of terms for digital health endpoints
  • Summary of interview results
  • Expert meeting summary

CTTI will conduct glossary term evaluations, literature reviews, and landscape assessments – as well as in-depth interviews and multi-stakeholder expert meetings – to collect data that will inform the new recommendations and resources.

These solutions will serve to increase the use of meaningful DHT-derived novel endpoints in clinical trials for labeling claims and help to advance the benefits of running digital health trials, including the capture of more meaningful and higher quality research data.