Decentralized Trials & Research Alliance
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Decentralized Trials & Research Alliance (DTRA) is a 501(c)(3) nonprofit organization in the United States that works to accelerate the adoption of patient-focused, decentralized trials and research within life sciences and healthcare through education and research. DTRA works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.[1]
Launch of DTRA
[edit]Dr. Amir Kalali, M.D. and Craig Lipset are the organization's co-chairs and launched the DTRA on December 10, 2020. They discussed the challenges that decentralized research can address in a piece published in STAT on January 29, 2021, where they confirmed that membership in the organization had reached over 100 collaborating organizations that share the mission of DTRA.[2]
The importance of decentralized research
[edit]Disadvantaged communities have traditionally been largely underrepresented in clinical trials.[3] Decentralized research that leverages available communications, telemedicine, artificial intelligence and other technologies has been proposed as a way to help recruit a more broadly representative patient population by gender, ethnicity, age, geography, income and more.
In an interview in Clinical Leader,[1] Kalali discussed increasing clinical trial options for diverse patient populations and was quoted as saying, "Patients want options, and decentralized methodologies present them with those options. In the future, the average patient will be someone who grew up around the technology and is familiar with using it. If pharma wants to have patients participate in trials, it needs to go where patients want them to be. The younger generation has gotten used to having these technologies in other sectors, and it is how patients will want to interact with trials. The risk for our studies going forward will no longer be whether we can introduce these technologies in our trials. The new risk will be not giving patients new opportunities to engage with trials. This is a real opportunity to create sustained momentum."
MedCity News highlighted decentralized trials as one of the strategies that would make 2021 a "banner year" for life science industries, and cited the DTRA as uniting "industry stakeholders with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research".[4]
Impact of COVID-19
[edit]As a result of travel restrictions and the social distancing required to mitigate against the COVID-19 pandemic, clinical trials were affected worldwide. According to a study published in June 2020 by researchers at the University of Texas MD Anderson Cancer Center, of the 1,052 clinical trials that were suspended during the period from March 1 to April 26, 2020, at least 905 were suspended because of COVID-19.[5]
It has been noted that the impacts of COVID-19 may have set back clinical trial research several years[6] because of prospective patients' reluctance or inability to schedule physical visits at research locations. Decentralized clinical trials have emerged as an answer to that problem, as outlined in a report from Oracle Health Sciences.[7]
Kalali told MobiHealth News in December 2021, "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. The COVID-19 pandemic has forced organizations to adopt decentralized methodologies, which have the potential to broadly accelerate drug development."[8]
References
[edit]- ^ a b Miseta, Ed (January 19, 2021). "The Decentralized Trials & Research Alliance Hopes To Advance Studies". Clinical Leader.
- ^ Kalali, Amir; Lipset, Craig (January 29, 2021). "Decentralized clinical trials need collaboration to achieve wider use". STAT.
- Tirumalaraju, Divya (June 3, 2021). "Greenphire joins DTRA to expedite decentralised trials". Clinical Trials Arena. - ^ Thoelke, Kent (October 28, 2020). "There's a silent crisis in clinical research. And it's not Covid-19". STAT.
- ^ Ripton, J. T. (January 26, 2021). "Strategies that will help make 2021 a banner year for life sciences industries". MedCity News.
- ^ Asaad, Malke; Habibullah, Nilofer Khan; Butler, Charles E. (2020). "The Impact of COVID-19 on Clinical Trials". Annals of Surgery. 272 (3): e222–e223. doi:10.1097/SLA.0000000000004113. PMC 7467053. PMID 32541234.
- ^ Plana, Deborah; Arfè, Andrea; Sinha, Michael S. (July 8, 2020). "Re-Envisioning Clinical Trials During The COVID-19 Pandemic". Health Affairs Blog. doi:10.1377/forefront.20200702.963588.
- ^ Miseta, Ed (January 7, 2021). "Pandemic Accelerates The Evolution Of Clinical Trials". Clinical Leader.
- ^ Hackett, Mallory (December 16, 2020). "Alliance forms to accelerate adoption of decentralized clinical trials". MobiHealthNews.