Abstract Details

Title The Effect of Trainings and Site Initiation Visits on Clinical Trial Non-Compliance in Neurology Research

Topic Practice, Policy, and Ethics

Presentation(s) Practice, Policy, and Ethics Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 001

Objective In an effort to minimize protocol deviations in neurological research that can compromise patient safety, delay study completion, and result in premature termination and added costs, we investigated a database of non-compliance findings to determine the effect of investigator trainings and site initiation visits (SIVs) on protocol compliance.

Background Over the last decade, there have been advances in developing treatments for neurological disorders and in research opportunities to study these diseases. Yet, there is no formal training in the methods of conducting research during medical school or residency. Therefore, procedures need to be established to mitigate potential harm.

Design/Methods Protocol audits conducted at NINDS from 2003 to 2019 on 97 research protocols were retrospectively analyzed. Based on the depth of auditing and provision of investigator training, audits were separated into 4 arms: 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 of protocol deviation, the category, and the cause.

Results 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 non-compliance 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.

Conclusions Protocol deviations and non-compliance 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.

Authors/Disclosures
Matthew Gooden PRESENTER	Matthew Gooden has nothing to disclose.
Gina Norato	No disclosure on file
Sandra Martin (National Institutes of Health)	Sandra Martin has nothing to disclose.
Avindra Nath, MD, MBBS, FAAN (National Institutes of Health)	The institution of Dr. Nath has received research support from National Institutes of Health. The institution of Dr. Nath has received research support from Target ALS. Dr. Nath has received intellectual property interests from a discovery or technology relating to health care.
Lauren Reoma, MD, FAAN (NIH/NINDS)	Dr. Reoma has received research support from NIH. Dr. Reoma has a non-compensated relationship as a Vice Chair with AAN Experimental Neurotherapeutics Section that is relevant to AAN interests or activities. Dr. Reoma has a non-compensated relationship as a Federal Employee with NINDS/NIH that is relevant to AAN interests or activities. Dr. Reoma has a non-compensated relationship as a Member with ASENT Program Committee that is relevant to AAN interests or activities.

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