Originally published in Clinical Leader

From The Editor | January 19, 2021

Ed Miseta

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

doctor-patientIn 2019 Amir Kalali celebrated the 10th anniversary of the CNS Summit. Kalali, biopharma executive, and the chairman and chief curator of the Summit, notes decentralized trials have been a hot session at the conference for the last few years. The individuals speaking on the topic have long felt the need for a space to gather the leaders in this area to work together.

“We would get together once a year and discuss decentralized trials, but I always felt we could do better,” he says. “To really galvanize the community, I felt we needed a nonprofit group. I have founded nonprofits in the past, and felt it was the best way to bring everyone together, including industry, regulators, and patient groups. This was an idea we were discussing even prior to the pandemic.”

The pandemic has certainly increased the urgency to create a group to promote decentralized trials. Amir Kalali and Craig Lipset, advisor and founder of Clinical Innovation Partners, spent a good portion of 2020 reaching out to pioneers in the clinical space who were working on decentralized trials. Conversations centered on the decentralized tools being used in trials and what more could be done to scale their use. They took what they learned and worked together to create the Decentralized Trials & Research Alliance (DTRA) to accelerate the adoption of decentralized methodologies in research.

Lipset certainly understands the extent of the challenge. He has been involved with decentralized clinical trials for more than 10 years and has interacted with sponsors, sites, and tech companies. He notes this is one of the most active areas where he is seeing requests for help.

Craig Lipset, founder, Clinical Innovation Partners
Craig Lipset

“As the pandemic hit, those calls only escalated,” he states. “So many of the questions and needs that were raised were not unique to one individual company. I have had the pleasure of working with TransCelerate and CTTI, and I was able to see the power of multi-stakeholder initiatives and the potential for change they can bring. Unfortunately, there wasn’t any multi-stakeholder initiative exclusively focused on this challenge. That is the space we are going after with this initiative.”Now Is The Time

Both Kalali and Lipset agree that when it comes to decentralized trials, now is the time for the entire industry to get behind the methodology. Initially the motivation behind decentralized trials revolved around improving patient access to trials, the patient experience, and diversity. Some companies may have been looking for cost savings which could result from better recruitment and retention. However, in 2020, the adoption of decentralized trials was driven by the pandemic and the desire to reduce risk and maintain continuity. Although risk mitigation drove the adoption, Lipset believes the desire to do right by patients is what will continue adoption in 2021 and beyond.

“There is a long history of technology adoption happening slowly in the life sciences,” states Lipset. “We have quickly moved from testing the technology in pilots to rolling it out in active trials. The FDA did a great job of issuing specific guidance to industry around how to maintain trials during the pandemic. One of the things the pandemic did was cause companies to put aside the excuses they had for not implementing technologies within their portfolio. In 2020 companies no longer had a choice. New technologies had to be implemented to take care of trial participants.”

DTRA is working with sponsors, patient groups, and sites, but it is also working with the service companies enabling decentralized trials. For Lipset, that was an important piece of the puzzle. Those companies have been attending conferences like the CNS Summit for years. The industry would gather at these events, everyone would share their stories, and disperse. The goal with DTRA is to maintain that momentum with ongoing initiatives.

“The membership of DTRA is diverse,” says Lipset. “That is what will make this group truly unique. We have top pharma companies, biotech firms, leading technology companies, and niche providers. We have CROs, patient advocacy groups, and the voice of the FDA. Every stakeholder involved in the conduct of clinical trials is represented in this group.”

When it comes to decentralized methodologies as with any new approaches, not all companies are in the same place on that journey,” adds Kalali. “We hope one of the benefits of DTRA will be the ability of companies to learn from each other. The question is, how do we help them to do that? Sponsors can easily de-risk their own programs by finding someone else who is already doing it and learning from them. With DTRA, we hope they can meet, engage, and learn from each other.”

Collaborate And Avoid Overlap

Other groups, such as DiME, CTTI, and TransCelerate, to name a few, are also involved with promoting digital tools and decentralized trials. Lipset notes there is a complex web of organizations that have a hand in decentralized trial adoption. DTRA has been proactively reaching out to those organizations to ensure transparency around the scope of each organization.

“We all benefit from some level of coordination between the groups and are actively launching collaborations,” says Lipset. “Some of the initiatives from different organizations may be solving a discreet challenge in the decentralized trial space. We have no interest in reinventing what has already been done. Still, we do hope to make connections that will help leaders simplify adoption. So far, there has been a lot of interest in partnering, and we hope to share more information on that in the coming weeks.”

Kalali adds that both he and Lipset have contacts within those groups, and one goal of DTRA is amplifying the good work those groups are doing and coordinate where possible. For those groups, decentralized trials are just part of what they do. DTRA hopes to be a clearing house and trusted voice in the industry for all things having to do with decentralized trials. Many of the same executives serve on many of these initiatives, which should foster greater collaboration.

Give Patients Options

Amir Kalali
Amir Kalali

Where does the effort go from here? Kalali notes DTRA had its first leadership council meeting in December 2020 and the future initiatives of the group will be based on the council’s vision. Some of the themes that were raised at that meeting include streamlined adoption of decentralized trial technologies and making the trials more mainstream.“Looking ahead we do not want to be discussing decentralized trials,” says Lipset. “We want to talk about clinical trials and know these technologies will be part of that. Decentralized technologies can no longer be an additional burden for overworked study teams. It needs to be the accepted way of conducting a trial in the future.”

“The future is here,” adds Kalali. “Patients want options, and decentralized methodologies present them with those options. In the future, the average patient will be someone who grew up around 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.”

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