Abstracts

Rationale: Patient safety is of the utmost importance in a clinical trial. While clinical trials allow patients to try the newest pharmacological treatments available, medical emergencies do occur during patient participation. In order to secure patient safety and appropriate treatment, communication between emergency physicians and research staff is essential. We reviewed serious adverse events (SAE) records in order to evaluate the effectiveness of communication between research staff and emergency physicians, and to identify the area of improvement to further secure patient safety. Methods: We retrospectively reviewed SAE records from epilepsy patients who previously participated in Phase II and III clinical trials at the Barrow Neurological Institute from 2003 to 2009. Data collected was to determine if patients were identified as clinical trial participants upon presenting to the emergency department (ED), what communication took place between ED and research staff, and if medical treatments patients received resulted in any violations to study protocols. Results: There were 11 clinical trials with 63 patients. A total of 17 SAEs were reported. The study population consisted of 53% females with a median age of 41 years (22 to 56). When patients presented to ED, 24% were identified as clinical trial patients by either triage or the treating physician, while 59% of patients reported to the ED current treatment with an investigational drug/device. In 47% of the cases, ED staff was able to contact the principle investigator (PI), sub-investigator (sub-I) or study coordinator (SC). In cases where treating physicians spoke with the PI or Sub-I, patient care was directed by the study physician. Among cases where treating physicians did not contact, 56% of the emergencies were related to seizures or AED toxicity. As a result, 12% of patients had their investigational product (IP) discontinued and 6% had IP withheld by ED staff. Of the 12% whose IP was discontinued, all patients were withdrawn from the clinical trial. Conclusions: In order to optimize the treatment and safety of patients during clinical trials, communication between treating physicians and research staff is critical. However, our study suggests that such communication occurs in less than half of the cases of medical emergencies. Identification of research patients by clinical trial cards, medical alert bracelets and education of patients and physicians may help to improve communication.