Medable Inc., a leader in technology for modern clinical trials, has released important findings from a study conducted by the Partnership for Advancing Clinical Trials (PACT) consortium in partnership with the Tufts Center for the Study of Drug Development (CSDD). This research involved 13 clinical trial sponsors and contract research organizations, examining 60 trials that implemented decentralized solutions. The findings reveal that these trials achieved or even exceeded the planned timelines for critical phases, such as from the activation of the first site to the enrollment of the initial patient, and from the enrollment of the first patient to the final patient.

These trials typically used an average of four digital tools or Decentralized Clinical Trial (DCT) elements, primarily to support study visit activities. Sponsors also indicated that they believe that about one-third of all protocol procedures and half of all study visits could be performed remotely.

Ken Getz, Executive Director and research professor at Tufts CSDD, commented, “The high data completion rates across various metrics confirm the consortium's goals and validate the effectiveness of these technologies. The growing dataset provides valuable insights into the hybrid use and impacts of specific DCT solutions, with encouraging signs of their potential benefits.”

Early data from the PACT research also suggests that trials using DCT elements tend to feature a more diverse group of participants, with fewer white participants and more Asian participants compared to traditional trials.

Medable, emphasized, “At Medable, we are committed to supporting the Tufts/PACT consortium in capturing essential data. Preliminary evidence indicates that digital technologies can improve population diversity in clinical research, which is a key objective.”

Medable, ranked among the top 8% of software companies in the 2023 Inc. 5000, has deployed its software-as-a-service platform in over 300 decentralized and hybrid clinical trials across 60 countries, impacting more than one million patients and research participants globally. These trials have shown remarkable results, including twice the speed of enrollment and 50% cost savings. Research by Tufts CSDD indicates that decentralized trials could achieve net financial benefits that are five to thirteen times greater than the initial investment for Phase II and Phase III trials, with expected returns of approximately $10 million and $39 million, respectively, on investments of $500K and $1.5M.

 

Source: businesswire.com

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