Tubestop - Protocol Design

Description

Clinical protocol design is the process of creating a detailed plan for a clinical trial, including the study objectives, design, methodology, and statistical considerations Decentralized clinical trials protocol design includes defining the processes, technologies and services needed to allow the trial to be conducted at locations other than a traditional clinical trial investigator site with patients participating from their homes or other locations.

DCT-specific Considerations/Inputs

Describe the DCT components as text within the protocol and Informed Consent Form (ICF)
Glossary of Terms
DCT Curriculum

Design Optimized DCT with Engaged Stakeholders
Glossary of Terms
Best Practices
DCT Curriculum
Seek Patient Input

Develop Informed Consent with DCT specific information. Develop recruitment plan and collateral (Patient facing materials )
TransCelerate: eConsent Implementation Guidance; Supporting Tools and Resources

Biomarker / Digital Biomarker Needs
Technology and Data Standards
Data Connectivity
Consider cultural "norms of practice" that might differ between locales involved in the DCT (Change Management: "Site Adoption Concerns")

Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (See Q&A)

FDA’s Guidance on Decentralized Trials and Digital Technology

21 CFR Part 50 and Guide to Informed Consent

U.S. FDA Draft Guidance Document: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

ICH E9 statistical principles for clinical trials - Scientific guideline

EMA Guideline on computerised systems and electronic data in clinical trials

The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products

Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products

European Medicines Agency Recommendation Paper on Decentralised Element in Clinical Trials Version 01, 13 December 2022

Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative - PMC (nih.gov)

ACRO : Decentralized Clinical Trials

Advarra : Defining Decentralized Clinical Trials and Understanding Their Nuances

European Forum GCP eConsent initiative - Suite of eConsent Tools

TransCelerate : Modernization of Statistical Analytics Solutions

Transcelerate Modernizing Clinical Trials

Five Key Considerations for Designing and Implementing Decentralized Clinical Trials

TransCelerate eConsent Supporting Tools & Resources

MRCT IRB/EC Considerations - Full Document

MRCT IRB/EC Considerations - Participants & Technology

CTTI Recommendations: Decentralized Clinical Trials

CTTI Resource: DECISION TREE: OPTIMIZING YOUR PROTOCOL DESIGN

CTTI Resource: HOW TO IDENTIFY & PRIORITIZE TRIAL STAKEHOLDERS

CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials

NIH - Informed Consent for Research Using Digital Health Technologies