The DPMCDA Regulatory Affairs Branch provides consultation and advice on clinical and non-clinical medication development requirements and strategy to NIDA grantees, contractors, and other interested parties regarding projects of mutual interest. In addition, the Branch maintains contact with the FDA to lead filing of IND applications, and NDAs as new medications enter or complete clinical studies. Regarding safety concerns, the Branch tracks information to improve NIDA's oversight of clinical trial safety, and to identify post-marketing safety issues. The Branch monitors patient safety by promptly assessing serious adverse event reports. An electronic data capture system provides rapid access to SAE data, including characterizations of severity, relatedness, and expectedness. A patient profile visualization system allows review of these events in context of other clinical data about individuals in clinical trails. This monitoring helps the Regulatory Affairs Branch detect, assess, and understand adverse events in a timely manner, and to perform regulatory reporting responsibilities. The Branch also monitors data from post-marketing safety databases, watching for drug-event combinations that warrant further analysis. To learn more about the DPMCDA's clinical trial safety oversight initiatives select from the following areas: Serious Adverse Event Tracking and Reporting System | Pharmacovigilance | Patient Profile/Monitoring Application
Pharmacovigilance 
NIDA needs to assimilate safety data from clinical studies with post-marketing safety data to form conclusions about reported side effects of addiction treatment medications. SAETRS and the Executive Information System (EIS) Safety data mart in the Clinical Data Repository enable data mining and signal detection techniques for the identification of associations between medications under study and their adverse drug reactions. A set of statistical analysis tools applied to post-market public-use safety data provides insight into potential concerns with both candidate and approved medication therapies. For already approved drugs that NIDA is researching for potential use in treating addiction, this knowledge gives a baseline understanding of expected adverse reactions before a clinical trial even begins providing important knowledge of potential side effects that study clinicians can monitor. These tools accelerate the discovery of clinically significant safety issues, allowing NIDA to make rapid, well-informed decisions about the safety both of trial participants and of patients using approved medications. Patient Profile/Monitoring Application 
Patient profile visualization facilitates medical review by enabling researchers to see patient data in a graphical format along a common time axis with annotations. Using this application, NIDA monitors view the detailed clinical assessment surrounding a specific adverse event, including other medications, baseline and on-study medical assessments, patient vital signs and laboratory results, and other adverse events the trial participant may have experienced. Such detailed tracking of unusual values or relationships within patient data provide insights into safety concerns as highlighted by the aggregate level monitoring tools. The software works directly with the Clinical Data Repository, via the EIS Safety data mart, and with the SAETRS data, to generate individualized comprehensive patient profiles. In addition to these participant-level data visualizations, the tool plots various analytical graphs, for one or more studies. Presentations such as delta graphs and scatter plots help visualize correlations, distributions of data and drilldown to individual case profiles available from any of these graphs. |
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