Managing a Successful Phase 2/3 Direct-to-Patient Trial Using IRT

How Bellerophon Therapeutics is using IRT to successfully handle the multiple layers of complexity within a Direct-to-Patient trial

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Direct-to-Patient Trials

How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges.

What You Will Learn

  • Benefits and challenges associated with the Direct-to-Patient model
  • Bellerophon's top considerations when implementing this trial design
  • How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges