Reducing Events of Noncompliance in Neurology Human Subjects Research: the Effect of Human Subjects Research Protection Training and Site Initiation Visits

• Published in: Neurotherapeutics Vol. 18; no. 2; pp. 859 - 865
• Main Authors: Gooden, Matthew J., Norato, Gina, Martin, Sandra B., Nath, Avindra, Reoma, Lauren
• Format: Journal Article
• Language: English
• Published: Cham Elsevier Inc 01.04.2021; Springer International Publishing; Springer Nature B.V
• Subjects: Biomedical and Life Sciences; Biomedical Research - methods; Biomedical Research - standards; Biomedicine; Clinical Competence - standards; Clinical Protocols - standards; Clinical trials; Current Perspectives; Current s; Databases, Factual - standards; Human Experimentation - standards; Human subjects; Human subjects research; Humans; National Institute of Neurological Disorders and Stroke (U.S.) - standards; Nervous System Diseases - epidemiology; Nervous System Diseases - therapy; Neurobiology; Neurological diseases; neurological investigator training; Neurology; Neurology - education; Neurology - methods; Neurology - standards; Neurosciences; Neurosurgery; Noncompliance; outcome research; Patient safety; Research Subjects; site initiation visits; United States; United States; patient safety; Human subjects research; outcome research; neurological investigator training; site initiation visits
• ISSN: 1878-7479; 1933-7213; 1878-7479
• DOI: 10.1007/s13311-020-01003-4

In an effort to minimize protocol noncompliance in neurological research studies that can potentially compromise patient safety, delay completion of the study, and result in premature termination and added costs, we determined the effect of investigator trainings and site initiation visits (SIVs) on the occurrence of noncompliance events. Results of protocol audits conducted at the National Institute of Neurological Disorders and Stroke from 2003 to 2019 on 97 research protocols were retrospectively analyzed. Based on the depth of auditing and provision of investigator research training, audit data were separated into four arms: 1) Early Period, 2003 to 2012; 2) Middle Period, 2013 to 2016; and Late Period, 2017 to 2019, further divided into 3) Late Period without SIVs; and 4) Late Period with SIVs. Events of noncompliance were classified by the type of protocol deviation, the category, and the cause. In total, 952 events occurred across 1080 participants. Protocols audited during the Middle Period, compared to the Early Period, showed a decrease in the percentage of protocols with at least 1 noncompliance event. Protocols with SIVs had a further decrease in major, minor, procedural, eligibility, and policy events. Additionally, protocols audited during the Early Period had on average 0.46 major deviations per participant, compared to 0.26 events in protocols audited during the Middle Period, and 0.08 events in protocols audited during the Late Period with SIVs. Protocol deviations and noncompliance events in neurological clinical trials can be reduced by targeted investigator trainings and SIVs. These measures have major impacts on the integrity, safety, and effectiveness of human subjects research in neurology.