The International Neonatal Consortium (INC, http://c-path.org/programs/inc/) held the Second Annual Neonatal Scientific Workshop meeting at the Food and Drug Administration (USA) on March 7-9, 2016. This consortium is an interdisciplinary group representing industry, academics, researchers, health professionals, parents, and regulators from around the world. The focus is on therapies and medications used in neonatal care. Very few of these drugs are ever tested in this population. For instance, of 406 medications studied in the pediatric population, only 28 had been studied in neonates (Stiers & Ward, 2014). Clinical trials are needed to determine safety and efficacy of these medications as well as sharing of the data. Since launching INC in May 2015, working groups have formed within this project. Topics range from Bronchopulmonary Dysplasia, Seizures, Clinical Pharmacology to Retinopathy of Prematurity, Data, and Communication. The first deliverable of the International Neonatal Consortium, the white paper developed by INC’s Clinical Pharmacology Workgroup: Considerations Regarding Safety, Dosing, and Pharmaceutical Quality for Studies that Evaluate Medicinal Products (including Biological Products) in Neonates, will be soon disseminated broadly.
The INC meeting brought together all stakeholders to talk about the challenges and opportunities for future research. Nurses are usually at the frontline of clinical trials – either in assisting with protocols or explaining to parents in lay terms what the trial is about. Yet, few nurses are involved in the actual development of the trial itself. Parents too are often left bewildered about what they are being asked to participate in on behalf of their infant. The Council of International Neonatal Nurses (COINN) along with the National Association of Neonatal Nurses (NANN), Preemie World, Preemie Parent Alliance contributed to this meeting describing how vital nurses’ and parents’ voices were in clinical trials and how their input and expertise could facilitate the development and implementation of research protocols. The next face to face meeting of INC will be held in London in September 2016.
Stiers, J. L., & Ward, R. M. (2014). Newborns, one of the last therapeutic orphans to be adopted. JAMA Pediatrics, 168(2), 106-108. doi:10.1001/jamapediatrics.2013.4604