5. Utilizing Human Subjects Research Protection Trainings and Site Initiation Visits to Improve Participant Safety in Clinical Neurology Research

The purpose of this study was to investigate a database of non-compliance findings from clinical research conducted at the National Institute of Neurological Disorders and Stroke to determine the effect of research trainings and site initiation visits (SIVs) on protocol compliance. This research aims to determine methods to mitigate protocol deviations in neurology research that can lead to compromised participant safety, delayed study completion, and poor data quality. Retrospective analysis of 97 protocol audits completed between 2003 and 2019 was conducted at the National Institute of Neurological Disorders and Stroke. Audits were separated into four time periods, as follows, corresponding to the initiation of research trainings and SIVs: 1) Early Period, 2003-2012; 2) Middle Period, 2013-2016; and Late Period, 2017-2019, further divided into 3) Late Period without SIVs; and 4) Late Period with SIVs. Events of non-compliance were classified by the type, category, and cause of deviation. 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 a non-compliance event. Protocols with SIVs had a further decrease in major, minor, procedural, eligibility, and failure to follow policy non-compliance events. Protocols audited during the Early Period had on average 0.46 major deviations per participant, compared to 0.26 major deviations in protocols audited during the Middle Period and 0.08 major deviations in protocols audited during the Late Period with SIVs. Our study suggests that protocol deviations and non-compliance events in clinical trials can be reduced by targeted research trainings and SIVs prior to participant enrollment. These measures have a potential major impact on the integrity, safety, and efficacy of studies that advance the development of improved therapies for nervous system disorders. Over the last decade, advances in neurology research have grown, but there is little to no formal training in the methods of conducting research during medical school, residency, or fellowship for aspiring clinician-researchers in neurology. This study suggests that procedures, such as human subjects research protection trainings and SIVs, should be targeted interventions incorporated into the armamentarium of all clinician-researchers in neurology research. 
 

  • Matthew Gooden
  • Gina Norato
  • Sandra Martin
  • Lauren Reoma
  • National Institute of Neurological Disorders and Stroke, National Institutes of Health

Authors Participating In This Event

Matthew Gooden

Research Fellow, NIH/NINDS

Research Fellow

NIH/NINDS

I am an Intramural Research Training Award (IRTA) Fellow in the Clinical Trials Unit. Working primarily within the Office of Quality Assurance and Data Management, I have helped to develo...