investigator-sponsored trials (ISTs)

In an investigator-sponsored trial (IST), the investigator assumes responsibility for all aspects of the research including:

• Study design
• Ensuring appropriate institutional, regulatory, and ethics committee approval
• Study conduct, including responsibility for ensuring appropriate medical safeguards, adequate record keeping, medical monitoring, adverse event reporting, and medical supervision

Requirements
All applicable regulatory requirements including, but not limited to, study registration and results disclosure must be observed. Investigators who receive support through the Ikaria IST program must submit a final study report/summary to Ikaria at the conclusion of the study.

Disclaimer

Requests for research proposals are not to be interpreted as suggesting that any product is safe or effective for an investigational use or recommended for any use outside of the FDA-approved label. Ikaria does not guarantee support. Please note that studies may be submitted for “drug-only” support as well as drug and funding support.

Further information

To be considered for an IST, please read the trial criteria terms and conditions. To speak with Ikaria about conducting an IST, click here.