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
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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
Site Planning | Press Releases
CTTI Launches New Online Digital Health Trials Hub
Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.
Regulatory Submissions + Approvals | Expert Meetings
Obtaining Novel Endpoint Reliability and Acceptance Expert Meeting
Expert Meeting Recap and Materials
Regulatory Submissions + Approvals | Webinars
Next Steps for Obtaining Novel Endpoint Reliability & Acceptance
CTTI Project: Developing Novel Endpoints Webinar Presenters: Michelle Crouthamel, AbbVie Jennifer Goldsack, DiMe Lindsay Kehoe, CTTI Alicia Staley, Medidata Webinar Resources: Download PowerPoint slideset Mentimeter Results
Patient Engagement | Case Studies
FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers
FPWR's Questionnaire Measures Important - But Often Overlooked - Concerns for Prader-Willi Patients and Caregivers
Data Collecting and Reporting | CTTI News
CTTI Publication Investigates Challenges and Solutions Surrounding Digitally Derived Endpoint Acceptance
A new CTTI publication, published in Digital Biomarkers, investigates the challenges sponsors encounter when using digitally derived endpoints and offers potential solutions. Digital health technologies – including mobile apps, smart...
Regulatory Submissions + Approvals | Publications
How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints
Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is...
Regulatory Submissions + Approvals | Case Studies
From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints
From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints
Regulatory Submissions + Approvals | Resources
Question Bank for Identifying Meaningful Outcome Measures
Question Bank for Identifying Meaningful Outcome Measures
Regulatory Submissions + Approvals | Resources
Preparing a Digitally-derived Endpoint for Key Endpoint Use
Preparing a Digitally-derived Endpoint for Key Endpoint Use
Recommendations
Digital Health Trials: Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials
Digital Health Trials: Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials
Regulatory Submissions + Approvals | CTTI News
Recording Now Available: “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” Webinar
A recording of CTTI’s public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” is now available. During the webinar, presenters Lindsay Kehoe (CTTI) and Alicia Staley (Medidata)...
Regulatory Submissions + Approvals | CTTI News
CTTI to Host 10/5 Webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance”
On Oct. 5 at noon ET, the Clinical Trials Transformation Initiative (CTTI) will host a public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” – the third...
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 | Resources
Flowchart: Steps For Novel Endpoint Development
Flowchart: Steps For Novel Endpoint Development
Regulatory Submissions + Approvals | Resources
Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations
Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations
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
Regulatory Submissions + Approvals | Resources
CTTI Novel Endpoints Interactive Selection Tool
CTTI Novel Endpoints Interactive Selection Tool
Regulatory Submissions + Approvals | Publications
Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010–2016: A Systematic Literature Review
The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future...
Regulatory Submissions + Approvals | CTTI News
CTTI to Lead Breakout Session and Offer Insights into Using Mobile Tech and Novel Endpoints in Clinical Trials at 2018 SCOPE Meeting
This year’s Summit for Clinical Ops Executives (SCOPE) conference will feature a notable presence from CTTI as part of the annual meeting’s first-ever Sensors, Wearables and Digital Biomarkers in Clinical Trials track. The meeting...
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 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...
Press Releases
CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations
CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations
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...
Regulatory Submissions + Approvals | CTTI News
Expert Meeting Materials Now Available: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical
On September 29-30, 2016, CTTI hosted a multi-stakeholder expert meeting to begin to develop recommendations for how to develop mobile technology–derived novel endpoints for use in clinical trials. Mobile technologies such as...
Regulatory Submissions + Approvals | Resources
Case Study: Developing Novel Endpoints Generated Using Digital Health Technology: Duchenne Muscular Dystrophy
Case Study for Developing Novel Endpoints Generated Using Digital Health Technology: Duchenne Muscular Dystrophy
Regulatory Submissions + Approvals | Resources
Case Study: Developing Novel Endpoints Generated Using Digital Health Technology: Diabetes Mellitus
Case Study: Developing Novel Endpoints Generated Using Digital Health Technology: Diabetes Mellitus
Regulatory Submissions + Approvals | Resources
Case Study: Developing Novel Endpoints Generated Using Digitial Health Technology: Parkinson’s Disease
Case Study: Developing Novel Endpoints Generated Using Digitial Health Technology: Parkinson's Disease
Regulatory Submissions + Approvals | Resources
Case Study: Developing Novel Endpoints Generated Using Digital Health Technology: Heart Failure
Case Study: Developing Novel Endpoints Generated Using Digital Health Technology: Heart Failure