Pursuant to the "NCATS Policy for Support of Phase III Clinical Trial Activities for a Rare Disease or Condition", NCATS is providing this public notice period and opportunity for any public or private organization to submit a reply on the contemplation of NCATS to support a Phase III clinical trial activity for a rare disease or condition (as defined here(link is external)). Specifically, NCATS seeks responses from any public or private organization with credible, timely plans to conduct Phase III clinical trials of a similar nature. Respondents must provide sufficient information to enable an accurate determination of whether the respondents’ clinical trial activities are timely and of a similar nature to the trial described below.
NCATS intends to support the following Phase III Clinical Trial(s) for a Rare Disease or Condition:
- "STeroids to REduce Systemic Inflammation After Neonatal Heart Surgery (STRESS),” details of which can be found at NCT03229538(link is external). (Posted on May 24, 2019).
Responses should include a credible, timely plan and contact information. Please direct all inquiries to: NCATS Policy Officer: NCATS_Phase_III_CT_P@mail.nih.gov