Jonathan Swanson

Many thoughts about this… 1) Parents of enrollees as of today haven’t even been notified of the results of the trial, including interim analysis at PAS 2023 that was all over social media, and the full study published yesterday. That’s unethical. Optics are not good. 2) If it causes harm for preemies, you’re going to have a lot more medicolegal issues on your hands if you cool them. Published data of increased death = a lawyer’s dream. Risk already discourages providers from naming the specific diagnosis of HIE. Can’t imagine they will be thrilled to cool babies with data showing significant increase of death. 3) Slipping on the shoes of the loss parents from the cooling group, a tough pill to swallow seeing more babies with statistical significance die in the cooling group will likely lead to a lot of “what if”-ing about participating in the trial. “Would my baby be alive if we didn’t do this trial?” Doesn’t matter that there’s a high mortality rate anyway. It’s higher in the cooling group. 4) The fact that communication and engagement was so poor with families enrolled in this trial is even more upsetting today after a good night’s sleep. This hurts research and neonatal trials. Perception of our healthcare system, birth, etc is at an all-time low. We need to work together to improve this. 5) The rest of the world has PPI/community stakeholder engagement mandates, FDA has them for industry. NIH (and we will continue to fight for the NIH and funding despite this!) is woefully behind when it comes to this. 5) We developed a framework of support that addresses these gaps based off of the thousands of families in our community who have been a part of clinical trials and research and their feedback. Their feedback is essential and they easily identify gaps that we have built solutions around. 6) Journals should have higher standards to ensure results being shared and published have an established communication and notification plan with those in the study prior to publishing and hold PIs/authors to it. This also happened with HEAL, as NEJM embargoed it, but we got a courtesy heads up to have resources in place and shared with our community the moment it went live. Families invest a lot of time and TRUST into these studies, and in clinical care. There are already effective models out there in clinical care and research, neonatology in the US must advance to catch up and change the culture. Always happy to discuss further. Feel free to reach out (anyone reading this, really). We have a strong bench of expertise on our staff — corporate, community and family communication in healthcare, health and educational literacy, social work, child life, and clinical research administration. We need to work together.