US-based biotechnology firm Novavax has started enrolling participants in a Phase I/II clinical trial of its Covid-19 vaccine candidate, NVX‑CoV2373, in Australia.
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
by Suvoda
Developed using the company’s nanoparticle technology, NVX‑CoV2373 is engineered from the genetic sequence of SARS‑CoV‑2.
The Phase I/II trial comprises two parts. The Phase I part is a randomised, observer-blinded, placebo-controlled study assessing the immunogenicity and safety of the vaccine candidate, adjuvanted with Matrix‑M, as well as unadjuvanted.
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It is recruiting around 130 healthy participants aged 18 to 59 years at two sites in Australia.
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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
by Suvoda