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David.Mitchell


Insights on Decentralized Clinical Trials: Biogen's Approach and Plans

2023-09-26

Biogen Inc. (BIIB) recently participated in the Decentralized Clinical Trials in Focus Conference, where the company's representatives engaged in a panel discussion on the topic. The meeting primarily focused on exploring the benefits and challenges associated with decentralized clinical trials (DCTs). Throughout the discussion, participants, including Donato Paolo Mancini, Stephanie Manson Brown, Jane Twitchen, Angela May, and Harpreet Gill, shared their insights and opinions on the subject.

One of the most significant topics discussed during the meeting was the implementation and advantages of decentralized clinical trials. The participants highlighted various considerations, such as the introduction of endpoints, accessibility to tools, and the importance of educating stakeholders about decentralized trials. They emphasized the benefits of real-time access to data metrics for both trial subjects and patients. Patient and investigator insights were deemed crucial, with an emphasis on not second-guessing what the patient truly wants. The participants also expressed varying opinions on the most suitable clinical phases for implementing decentralized clinical trials, with responses ranging from phases two, three, and four. Overall, the discussions surrounding decentralized clinical trials generated valuable insights and were considered a significant area of interest.

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During the meeting, the key drivers of Biogen Inc.'s business were identified as digital health endpoint development, cost savings, and patient outcomes. The company outlined its plans for its product and service, which include exploring digital health endpoint development and focusing on outcomes and patient burden reduction. They also expressed interest in introducing future endpoints at an earlier stage in their portfolio to expedite the product's market entry. Additionally, Biogen Inc. is evaluating the economics of decentralized clinical trials and considering mobile-based imaging solutions to reduce costs. The company is also deploying optional decentralized trial options for pediatric patients to alleviate patient and caregiver burden and attract more participants.

Several key performance indicators (KPIs) were discussed during the meeting. These included the cost per study, patient and caregiver burden, and recruitment of additional patients. The participants emphasized the need to identify cost-saving opportunities, particularly in areas such as imaging solutions and mobile-based technologies. However, they also stressed the importance of not solely focusing on cost reduction but rather on patient and caregiver outcomes. The potential benefits of deploying digital clinical trial options, especially for pediatric studies, were also discussed. Attracting additional patients, particularly in pediatric development, was identified as a crucial KPI for the company.

In conclusion, the panel discussion on decentralized clinical trials during the Decentralized Clinical Trials in Focus Conference provided valuable insights into the benefits and challenges associated with this approach. Biogen Inc. actively participated in the discussions, sharing their plans for digital health endpoint development, cost savings through decentralized trials, and a focus on patient outcomes. The company's exploration of decentralized clinical trials and their potential impact on patient burden and recruitment highlights their commitment to innovation in the field of clinical research.