Priority 4: Removing Barriers

Identifying Gaps and Issues That May Prevent the Adoption of DCTs or Their Benefits

Group 8

The Goal

DTRA’s Priority 4 aims to identify barriers in decentralized research implementation and create tools to overcome them. To achieve this, DTRA’s Priority 4 initiative teams will create a Global Conduct Map, collaborate on regulatory gaps, and focus on data connectivity. This will enable the continued adoption and successful execution of decentralized clinical trials.

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Global Conduct Map

The Global Conduct Map aims to develop a central library that contains regulatory, legal, privacy, and cultural information with dynamic links to relevant regulatory sites. This initiative will compile drafts for the US, EU, and APAC regions, identifying health authority guidance by topic and region, ultimately driving more clarity about global differences in DCT implementation to support adoption. 
Ami Balakumar - 4A
Ami Balakumar
Project Manager, Accenture
“Our final project will create a single place that identifies the key regulatory, legal and privacy concerns per country for anyone interested and working in the DCT ecosphere - closing the knowledge gap which remains to be a key barrier in driving DCT adoption.”
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Collaborate on Regulatory Gaps

This initiative involves conducting a gap analysis to identify where current regulations do not address DCT needs and engaging with regulatory authorities as needed. By distributing an industry survey to gain insights into health authority interactions and effectiveness, this initiative will inform the development of further deliverables to address regulatory gaps.
Jonathan Andrus - 4B
Jonathan Andrus,
Co-Lead, CRIO (previously Clinical Ink)
“The 4B work stream has issued a survey to DTRA members regarding health authority interactions around DCT implementation to help inform the development of further deliverables.”
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Data Connectivity

The data connectivity initiative focuses on defining norms for data collection and adoption while collaborating toward necessary standards. With identified workstreams for user requirements, architecture considerations, and data standards, subgroups will further define key details and requirements to be addressed in the overall framework/toolkit. This collaborative effort will tackle the pain points of data and connectivity throughout the trial process.
Moulik Shah - 4C
Moulik Shah
Project Manager, Advanced Clinical
“Our team has collaborated on defining the pain pointed of data and connectivity throughout the process. This exercise has been exciting, especially as we hear from various different perspectives that our diverse team brings.”