PUBLIC NOTICE

NIH National Center for Advancing Translational Sciences (NCATS) Notice of Intent to Support a Phase III Clinical Trial for a Rare Disease or Condition

 

Pursuant to the "NCATS Policy for Support of Phase III Clinical Trial Activities for a Rare Disease or Condition" (NOT-TR-18-025), NCATS is providing this public notice period (defined as 120 calendar days) 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). 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. (Posted on May 24, 2019. Responses due by 5 p.m. ET on September 20, 2019)

Responses should include a credible, timely plan and contact information. Please submit to NCATS_Phase_III_CT_P@mail.nih.gov.

Please direct all inquiries to:

NCATS Policy Officer
Email: NCATS_Phase_III_CT_P@mail.nih.gov