Press

Decentralized Trials & Research Alliance (DTRA) Shares Key Findings from Annual Meeting

Global Cross-Industry Collaboration Releases First Deliverable from Portfolio of Initiatives

Press Release

November 10, 2022 -- The Decentralized Trials & Research Alliance (DTRA), a non-profit organization dedicated to the global adoption of decentralized clinical trials and research within life sciences and healthcare, today announced several key initiative updates that will continue to progress throughout 2023. Specialized DTRA teams presented these initiatives during its 2nd Annual Meeting in Boston, MA, from November 6-9, 2022. The meeting was attended by select professionals from its global membership of leaders in decentralized clinical trials (DCTs) including regulators, pharmaceutical and biotechnology sponsors, contract research organizations (CROs) and other service providers, technology companies, research sites, and advocacy leaders.

“The life science industry is at a critical juncture in the adoption of decentralized research methods and the urgency to reduce the remaining barriers to global adoption will remain the cornerstone to our mission at DTRA,” said Craig Lipset, Co-Founder and Co-Chairman of DTRA. “Our meeting convened some of the best minds in decentralized clinical trials and, together, with the global regulatory community, we will continue to expose barriers to scale and will work together to address these gaps.”

Key themes included:

• Defining What Is a Site in 2023: Leaders from Care Access, CenExel, Circuit Clinical, CVS, Parexel, Sanofi, and Science37 explored the evolution of the site model coming out of the pandemic and where it is headed in the coming years. This panel identified and challenged areas of modernization still needed in order to ensure that research infrastructure is keeping pace with innovation in the field.
• Pathways for Global Regulatory Clarity and Harmonization: Leaders from FDA, EMA, Danish Medicines Agency and Israel Ministry of Health came together to describe the current state of acceptability of DCTs at global scale. The panel explored expectations for upcoming regulatory guidance for DCTs, and where there are opportunities to enhance harmonization.
• Executing on the Mission in a Challenging Market: Strategies for sustaining delivery despite the challenging economic market was discussed by leaders from BMS, Datacubed Health, Medable, Medidata, and THREAD. They also explored where shifts in priorities are needed given the convergence of the pandemic, recession and great resignation.

“As the presentations at the Annual Meeting of DTRA have demonstrated, we are making great progress on all our announced initial Initiatives, driven by our member-identified priorities,” said Dr. Amir Kalali, Co-Founder and Co-Chairman of DTRA. “This is just the beginning of our work, and I look forward to DTRA delivering more products in 2023 that enable the whole field to provide wider access for patients.”

Priority Initiatives that will be ongoing by DTRA:

• Global Acceptability of DCT Methods: The Regulatory Gaps team is using the trial lifecycle framework to assess where regulations are clear or ambiguous about using DCT methods. This is being digitized with links to the current guidance documents and references.
• Trial Conduct Impact: The Evidence of Impact team has conducted extensive research across stakeholder groups and publications to identify and quantify DCT impact in trial conduct. This body of evidence will grow as more trials are completed, and as the key performance indicators are applied by project teams to measure operational outcomes of DCT methods.
• Data Technology: A consistent theme at the Annual Meeting included how to ensure that data from DCTs will meet regulatory expectations. Two initiative teams are actively working to help address this need by creating a framework for data collection and interoperability for studies using DCT methods.

ABOUT DTRA:

The Decentralized Trials & Research Alliance (DTRA), a non-profit organization, was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. Follow DTRA on Twitter and LinkedIn for more information. A video accompanying this release is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f808d99b-8b9f-4578-9974-85cd1ea43f98

Decentralized trials & research alliance releases glossary as improved adoption of more accessible research approaches 

Press Release

August 29, 2022 -- The Decentralized Trials & Research Alliance (DTRA) today has announced the release of the DTRA Glossary, a result of cross-industry collaboration meant to improve the global adoption of decentralized research.

The DTRA Glossary is now accessible to the global research community and all relevant stakeholders at www.dtra.org.

This Glossary solves two major challenges: a lack of consistent terminology for use within and between organizations, and a lack of a lexicon to describe different archetypes of decentralized research. The glossary includes an interactive feedback collection tool to receive updates on existing terms while also identifying potential new terms.

The DTRA Glossary is the first output from DTRA’s 12 initiatives spanning four priorities as developed by the DTRA Leadership Council. The Glossary Team was co-led by Jared Klingeisen and Alison Poole with program management by Alexa Christensen. Information on the other initiatives can be found at www.dtra.org.

Dr. Amir Kalali, Co-Founder and Co-Chairman of DTRA said, “The release of the DTRA Glossary marks an important milestone in enabling understanding and uptake of methodologies that will improve access to research for patients. It is a testament of the collaboration of member organizations, and will be where the whole community will look to for consistent terminology.”

Craig Lipset, Co-Founder and Co-Chairman of DTRA said, “It is impossible to make progress when there is a Tower of Babel and we are not able to understand one another. This work builds up from the work of other important collaborations and projects, as referenced within the Glossary. This is just the first of a portfolio of new solutions coming forward from the DTRA initiative teams.”

ABOUT DTRA:

The Decentralized Trials & Research Alliance (DTRA), a non-profit organization, was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. Follow DTRA on Twitter and LinkedIn for more information.

one year in dtra meets goals & looks to the future

Clinical Leader, Ed Miseta

December 1, 2021 – 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: 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.

DECENTRALIZED TRIALS & RESEARCH ALLIANCE (DTRA) ANNOUNCES PRIORITIES AND INITIAL INITIATIVES

Press Release

Global Coalition Defines Initiatives to Accelerate the Adoption of Decentralized Research and Improve Access for Participants

MAY 17, 2021 – The Decentralized Trials & Research Alliance (DTRA) today announced its priorities and initial initiatives designed to realize the full potential of decentralized research to improve access and participation to make clinical trials more efficient, accessible and equitable. With more than 100 Member Organizations, DTRA is the leading multi-stakeholder initiative focused on accelerating the global adoption of decentralized research.

DTRA members have defined four priority areas as a framework for new initiatives:

1. To establish common nomenclature & definitions, archetypes and key performance indicators around the practice of decentralized research.
2. To identify and promote best practices in decentralized research.
3. To prioritize education by building a knowledge repository and mechanisms for information sharing.
4. To identify and remove barriers to decentralized research implementation, establishing roadmaps to their resolution.

A full listing of the initiatives grouped by priority area is available here. While each priority area has several associated initiatives, the following have been prioritized in the immediate term:

• Create a comprehensive Decentralized Research Glossary that is easily accessible to relevant stakeholders to establish common nomenclature and definitions including defining archetypes of decentralized trials.
• Establish a collaborative Best Practices Repository with dynamic updates of trusted resources for study teams to identify where existing pathways exist for areas perceived as challenges as barriers.
• Compile a Data and Knowledge Repository with evidence of the impact of decentralized research capable of supporting education, research, and awareness.
• Build a central library of global regulatory, legal, privacy, and culture information that contains dynamic links to relevant regulatory sites to assist in the removal of barriers to entry.

Over 100 DTRA Member Organizations are engaged in advancing policies, research practices and technologies that will accelerate the global adoption of patient-focused, inclusive, decentralized clinical trials and research. Members include life-sciences research companies and patient advocacy organizations; technology and service providers; and leading regulatory authorities, such as the U.S. Food and Drug Administration.

Organizations interested in becoming alliance members can visit DTRA.org.

ABOUT DTRA:
The Decentralized Trials & Research Alliance (DTRA) was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

DECENTRALIZED TRIALS & RESEARCH ALLIANCE (DTRA) REACHES MILESTONE OF 100 MEMBER ORGANIZATIONS

Press Release 

Growth of Global Industry Alliance Advances Mission to Increase Access to Clinical Trials and Research

April 26, 2021 (GLOBE NEWSWIRE) — The Decentralized Trials & Research Alliance (DTRA) today announced that it now counts more than 100 member organizations united in the shared mission to make clinical-trial participation widely accessible to patients. DTRA is the largest and only multi-stakeholder initiative focused on the global adoption of decentralized research methodology.

Ranging from life-sciences research companies to patient advocacy organizations, technology and service providers, and leading regulatory authorities, such as the U.S. Food and Drug Administration, the 100+ DTRA members are engaged in advancing policies, research practices and technologies that will accelerate the global adoption of patient-focused, inclusive, decentralized clinical trials and research.

“The commitment of these organizations and their reach and scale underscore our collective potential for advancing decentralized research,” said Amir Kalali, MD, co-chair of DTRA, life sciences executive, and founder of several collaborative life science communities.

“While the COVID-19 pandemic accelerated the adoption of decentralized research, we are now seeing the commitment of the research community working together to become a core resource in the clinical research toolkit,” said Craig Lipset, DTRA co-chair, clinical innovation advisor, and a pioneer in decentralized trials. “We are proud that the DTRA can serve as the center for the future of decentralized research.”

For a listing of the organizations participating in DTRA or for those interested in being part of the alliance, visit DTRA.org.

DECENTRALIZED TRIALS & RESEARCH ALLIANCE (DTRA) LAUNCHES TO DEMOCRATIZE AND ACCELERATE CLINICAL TRIALS

Press Release

New Global Industry Coalition Aims to Dramatically Increase Access for All Patient Populations in Clinical Trials and Research

December 10, 2020 – An historic alliance of life sciences and healthcare organizations seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA) plans to unite stakeholders, including healthcare companies, regulators, patient groups and research organizations, with a mission to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.

“The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate.”, said Amir Kalali, MD, life science executive, founder of several collaborative life science communities, and co-convenor of DTRA. “The COVID-19 pandemic has forced organizations to adopt decentralized methodologies which have the potential to broadly accelerate drug development.”

Experts estimate that COVID-19 may set back non-pandemic clinical trials by several years due to prospective patients’ inability or reluctance to schedule visits at physical research locations. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators. Inclusion of representative patient populations in clinical trials by race, age, and geographic location has long been an operational challenge.  COVID-19 has amplified the disparities and inclusion biases that have become hurdles for potential trial participants. 

“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives,” said Craig Lipset, DTRA co-convener, clinical innovation advisor, and a pioneer in decentralized trials. “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders we can remove remaining barriers to adopting new policies and practices that can impact patients today.”

“Equal access to clinical trials is the foundation of Stand Up To Cancer’s Health Equity Initiative and supports our mission to make every cancer patient a long-term survivor,” said Sung Poblete, CEO of Stand Up To Cancer. “SU2C and DTRA’s efforts are aligned in the goal of making it possible for any patient, anywhere, to access trials with convenience and safety, during the pandemic and beyond.”

DTRA Member organizations will provide expertise to identify and address gaps and needs and advance best practices through effective education and communication. Organizations interested in taking part can visit DTRA.org

ABOUT DTRA:

The Decentralized Trials & Research Alliance (DTRA) was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. Follow DTRA on Twitter and LinkedIn for more information.