The DTRA has launched an online community platform, named DTRA Circles, for its members to connect with peers across the clinical trial industry, the organisation announced earlier this week. DTRA Circles are open to its organisational and individual members.
DTRA Circles will offer bi-monthly or quarterly virtual meetups to discuss topics regarding decentralised clinical trials (DCTs) such as diversity, patient recruitment, and data management leads for DCTs. Also, the organisation will provide a Slack channel for each circle so members can communicate with each other at any time.
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“DTRA Circles are a way for you to connect and share with a community working on the same challenge that you are facing,” wrote co-founder and co-chairman Craig Lipset on his LinkedIn profile.
The DTRA’s initiative pipeline
When the DTRA was launched in 2020, its founding members identified four priorities to accelerate the adoption of DCTs: definitions, best practices, education, and removing barriers. Those priorities are divided into 12 initiatives to create a roadmap for strategic solutions.
One of the latest outputs by DTRA is its Best Practices Evaluation Rubric, which was released last month. The document aims to aid stakeholders in evaluating DCT best practices across the clinical trial lifecycle: programme and trial planning, trial set-up, conduct, close, and analysis. It also touches on five dimensions of a trial, such as measuring success, improving patient experience, impact on sites, operational and technical feasibility, and regulatory and ethical compliance.
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The organisation already released its DTRA Glossary, which aims to overcome communication barriers across DCT stakeholders. “If we don’t understand each other, it makes it harder for us to make progress and define key performance indicators,” Lipset told Clinical Trials Arena in September 2022. DTRA also released a guide to map patient journeys in several indications and crowdsource evidence of impact.
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By GlobalDataTwo initiatives, Global Conduct Map and Collaborate on Regulatory Gaps, aim to clarify and specify regulatory hurdles that the DCT industry is facing. At the beginning of the year, experts told Clinical Trials Arena that further regulatory guidance is something they expect to see in 2023. With EMA’s DCT recommendations paper coming out late last year, the industry is awaiting FDA’s take on DCTs. After a couple of years of being on the draft guidance agenda list, the FDA is likely to release it this year.
More insights on DCT adoption trends:
DCT Tracker: tracing industry’s adoption of decentralised clinical trials
A quarterly analysis that uncovers key trends and players in the clinical trial decentralisation arena.
Decentralised paediatric clinical trials trending up but study execution critical
DCT Adoption Tracker: Clinical Trials Arena investigates which paediatric disease spaces are using decentralisation the most and why.
Direct to patient: rocky road to remote drug delivery in clinical trials
While an obvious solution to lockdown measures, sending study participants investigational drugs directly is still an untapped opportunity even in trials that would benefit. Clinical Trials Arena finds out why.
Beyond clinical trial design: factors that impact decentralisation
DCT Adoption Tracker: Clear regulatory guidance, existing healthcare infrastructure, and local culture are key influencers for swift decentralisation uptake.
Women’s health clinical trials: breaking down barriers through decentralisation
Women tend to be harder to recruit for clinical trials due to socioeconomic factors. But decentralised study designs help ease barriers to participation.
Remote clinical trial monitoring uptake rises but validation questions swirl
DCT Adoption Tracker: Clinical Trials Arena reviews the burgeoning trend on remote monitoring and looks into the regulatory know-how needed to ensure success.
