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
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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
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.
Site Planning | Press Releases
CTTI Offers Path Forward for Using Decentralized Clinical Trials
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)—trials run through telemedicine and mobile health care providers—today at the DPharm:...
Site Planning | Press Releases
Conducting Multi-Center Trials: New Recommendations and Tool for Research
A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center clinical trials.
Site Planning | Expert Meetings
Decentralized Clinical Trials Update Expert Meeting
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...
Site Planning | Webinars
CTTI’s Digital Health Trials Hub: Revised Recommendations and New Resources for DCTs and Novel Endpoints
CTTI Project: Developing Novel Endpoints and Planning Decentralized Trials Webinar Presenters: Megan Doyle, Amgen Jorg Goldhahn, ETH Zurich Phil Green, CTTI Lindsay Kehoe, CTTI Elizabeth Kunkoski, FDA Jeremy Wyatt,...
Site Planning | Webinars
Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
CTTI Project: Clinical Trials Issues Related to COVID-19 Webinar Presenters: Pamela Tenaerts (Clinical Trials Transformation Initiative) Jacqueline Corrigan-Curay (FDA, CDER) Laura Cooke (Amgen) Bray Patrick-Lake (Evidation Health, Inc.) Ramya Thota...
Site Planning | CTTI News
CTTI Publication Explores Perceived Barriers and Recommendations Surrounding the Adoption of Decentralization
Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science,...
Site Planning | Publications
Adoption of Decentralization: Are Our Perceptions Holding Us Back?
Adoption of Decentralization: Are Our Perceptions Holding Us Back?
Site Planning | Case Studies
Accelerating eConsent Adoption During COVID-19
Accelerating eConsent Adoption During COVID-19
Site Planning | Resources
Clearing a Path for Broad Implementation of DCTs
Clearing a Path for Broad Implementation of DCTs
Site Planning | Resources
Considerations for Delivering an Investigational Product
Considerations for Delivering an Investigational Product
Site Planning | Recommendations
Digital Health Trials: Recommendations to Sponsors for Planning Decentralized Trials
Digital Health Trials: Recommendations to Sponsors for Planning Decentralized Trials
Site Planning | Case Studies
Rho Combines CTTI Resources to Operate with Optimal Efficiency and Data Quality
Rho Combines CTTI Resources to Operate with Optimal Efficiency and Data Quality
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...
Site Planning | Case Studies
Long Shot COVID-19 Treatment Yields Fast, Promising Results Using Decentralized Trial Approach
Long Shot COVID-19 Treatment Yields Fast, Promising Results Using Decentralized Trial Approach
Site Planning | Case Studies
Curebase Pioneers Completely Virtual Site to Meet Patients Where They Are
Curebase Pioneers Completely Virtual Site to Meet Patients Where They Are
Regulatory Submissions + Approvals | CTTI News
CTTI Updates DCT Recommendations in Response to COVID-19
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...
Site Planning | CTTI News
New CTTI Publication Maps the Road Ahead for Decentralized Clinical Trials
A peer-reviewed article highlighting CTTI recommendations for Decentralized Clinical Trials (DCTs) was published this month in Therapeutic Innovation and Regulatory Science. The article describes the process of identifying and addressing the legal, regulatory, and...
Site Planning | Publications
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Site Planning | CTTI News
New CTTI Recommendations Offer Path Forward for Decentralized Clinical Trials
CTTI released new recommendations on overcoming the legal, regulatory, and practical hurdles for planning and conducting decentralized clinical trials (DCTs) today during the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass....