Meet the Data and Safety Monitoring Board (DSMB) for the SURV1VE-2 Trial

Meet the Data and Safety Monitoring Board (DSMB) for the SURV1VE-2 Trial

Every clinical trial needs an independent team of experts whose sole mission is to protect participants, ensure the study is conducted safely, and maintain scientific integrity. For the SURV1VE-2 Trial, that team is our Data and Safety Monitoring Board (DSMB) — three highly respected leaders in neonatal care, statistics, and clinical trial methodology.

Our DSMB Members:

• Dr. Waldemar Carlo – Chair, with extensive experience leading large-scale neonatal trials.

• Dr. Myra Wyckoff – Neonatal expert, known internationally for her work in newborn resuscitation.

• Dr. Joseph Beyene – Statistician, bringing deep expertise in biostatistics and trial design.

What the DSMB Does

The DSMB meets every quarter to:

1. Protect all study participants — ensuring their safety is the top priority.

2. Safeguard participants’ interests — making sure their rights and well-being are respected.

3. Monitor trial conduct — keeping the study on track and ethically sound.

4. Advise investigators — providing guidance that protects the trial’s scientific integrity.

5. Oversee interim analyses — reviewing early data to identify any concerns or potential changes needed.

How They Work

All DSMB members have signed a formal DSMB Charter, which:

• Defines their roles, responsibilities, and qualifications.

• Outlines how and when meetings take place.

• Sets strict rules for confidentiality and communication.

• Details the content and format of reports.

This independent oversight ensures that the SURV1VE-2 Trial not only seeks answers to vital scientific questions, but does so with the highest standards of safety, ethics, and transparency.

Funding: