From The Editor | December 1, 2021

One Year In, DTRA Meets Goals & Looks To The Future

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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In November 2021, the Decentralized Trial & Research Alliance (DTRA) held its annual meeting in Boston. The DTRA was formed in 2020 with more than 70 founding members from pharma companies and their technology and service partners. The organization was started as the COVID-19 pandemic was sweeping the world and sponsor companies were scrambling to adopt decentralized technologies and keep their clinical trials on track.

DTRA has a goal of enabling the collaboration of stakeholders to accelerate the adoption of patient-focused decentralized clinical trials and research within life sciences and healthcare. The organization’s vision is to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

I took this opportunity to speak with Craig Lipset, DTRA’s co-chair, about the progress the organization has made and its vision for the future.

Ed Miseta: DTRA recently held its annual meeting in Boston. Who did the organization bring together for this meeting?

Craig Lipset, co-chair, DTRA
Craig Lipset: The DTRA Annual Meeting brought together our diverse and global membership including leaders in DCT from regulators, pharmaceutical and biotechnology sponsors, CROs and other service providers, technology companies, site networks, and advocacy leaders.

Miseta: What do you hope will come out of this meeting? Any expected takeaways you can share?

Lipset: The goals for the DTRA Annual Meeting included education and updates, initiative progress, as well as network and community building. Our members heard directly from patients and regulatory leaders, as well as leads from related initiatives in the community such as TransCelerate, CTTI, IMI, ACRO and SCRS. Our initiative teams had the opportunity to progress their work together, while also sharing updates. 

As one of the first in-person meetings for many of our attendees during the pandemic, the meeting was also an important place to safely network, connect, and develop key business-to-business relationships and collaborations.

Miseta: Decentralized trial technologies have been available for years, yet prior to 2020 most companies seemed to choose to not adopt them. What do you think was the reason for the hesitancy?

Lipset: Operating in a highly regulated environment with an important focus on ensuring participant safety, operators in clinical research have a tradition of being risk averse. During the lockdowns of the COVID-19 pandemic, new risk was introduced in the operating environment as patients were limited in their ability and willingness to have visits in clinical centers while many clinical centers had resources reallocated elsewhere in the overburdened health delivery system. With this shift in the environment, the adoption of decentralized research methods became an important countermeasure and risk mitigation strategy. This was accelerated by a combination of the availability of decentralized research solutions and technologies in the market as well as clear signals from regulators supporting these approaches during the pandemic.

With barriers to initial adoption navigated, the risk in continuing to use decentralized approaches in trials going forward is substantially reduced.

Miseta: What are some of the specific changes have you seen take place over the last 12 to 18 months?

Lipset: Over the last 12-18 months organizations have been focusing on commitment and scaling. Organizations have taken enterprise steps to modify SOPs and training, identify new partners and solution providers, modify templates, and manage change and culture. Many have resourced teams or named internal leaders to own and support protocol evaluation and support for decentralized trial approaches. These measures have placed a spotlight on the shared remaining barriers to global adoption, many of which can only be navigated through collaboration.

Miseta: DTRA was launched a year ago with the mission of accelerating the adoption of clinical trials. What kind of growth has DTRA seen over the past 12 months?

Lipset: DTRA growth has taken place across all dimensions. Our membership has continued to grow across all categories of organizations -- from pharmaceutical sponsors to in-country solution providers around the world. Our engagement with regulators and policymakers continues to expand. Our partnership with other associations and consortia has grown in purpose as we identify hand-offs through transparency. Perhaps most important, the 12 DTRA initiatives have grown through focus and active participation across our 130 member organizations.

Miseta: What do you feel are some of the important accomplishments DTRA has experienced over the last 12 months?

Lipset: DTRA initiatives have been an important focus of the past year. Our members have defined 4 key priorities and 12 specific initiatives meant to improve global adoption of decentralized trials and research methods. These initiative teams have been formed with charters refined to have specific and purpose-driven deliverables over the coming months.

DTRA has also built the world’s largest community of leaders in decentralized research, which has since triggered innovative business-to-business collaborations to improve solution delivery and experience for study teams, sites, and participants. This community has sent a strong signal of commitment within organizations, helping to support critical change management and culture campaigns across our members.

Miseta: Those are some great accomplishments. What comes next? Where do you go from here and what are the next goals that you hope the organization can accomplish?

Lipset: DTRA will be focusing on the delivery or our portfolio of initiatives, all of which are meant for the public domain and to serve the global research community. We will continue to expand our engagement and collaboration with global regulatory authorities, helping to address questions regarding DCT models and build confidence in data integrity and patient safety through evidence. Together with the global regulatory community we will expose areas of ambiguity that challenge study teams and work together to help address gaps. In addition to our current initiatives, DTRA members will also launch member-driven “Co-Labs”, as they identify and collaborate on other remaining barriers in the way of global implementation.