You Can Help Change How Clinical Trials in the NICU are Handled

The International Neonatal Consortium (INC) is currently collecting input on its “Considerations Regarding Safety, Dosing, and Pharmaceutical Quality for Studies that Evaluate Medicinal Products in Neonates” whitepaper. It was drafted by the INC’s Clinical Pharmacology Workgroup to help make the kinds of studies that contribute to the development of new medicines and medical devices just for preemies and infants more effective. While the target audience of the whitepaper is clinicians the group wants to get input from parents because they recognize that parents are an important part of the clinical trial process. You can help by sharing your thoughts with us!

Right now, we are collecting input from parents about the following elements of the whitepaper:

• Another important aspect of planning clinical trials involves input from parents and children.  They often provide input that often has not been considered before and their perspective on acceptable levels of risk may differ from that of the investigators or even the Ethics Committee. Efforts to include their perspective in the design and conduct of clinical trials should be encouraged.
• Parents, children and neonatal care providers can provide important advice about acceptable levels of risk relative to the potential benefits and should be included early in the planning process for all clinical trials involving children, especially neonates.
• Parents should be provided ample time to consider the study and to formulate questions about their child’s participation. The definition of ample time will depend on the context of the study. Families may visit sick neonates irregularly and consent procedures need to account for this. When it is appropriate for the study design, the process of continuous consent allows families to extend the decision-making process.

The questions we are hoping you will take the time to answer are:

• Do you feel comfortable with how these sections are phrased?
• Do these sections do enough to communicate that parents should be involved in clinical trials involving preemies and infants?
• What would you want clinicians beginning trials to know about the parent experience?
• What, if anything, would you add to these sections?

You can answer here in the comments or send your comments to [email protected]. We’ll be relaying parent comments to the INC’s Clinical Pharmacology Workgroup after January 22.

Thanks so much for taking the time to be a part of our research and advocacy efforts by adding your perspective!