The DPMCDA Clinical/Medical Branch plans, designs, and implements a comprehensive program
that evaluates investigational and marketed medications for their potential value in
treating substance abuse disorders. The Branch designs, conducts and monitors clinical
trials for safety and efficacy of new and currently marketed medications in the treatment
of substance abuse disorders. In addition, the Branch provides consultation and advice
on study design and analysis issues involved in clinical trials. To support the DPMCDA
Clinical/Medical Branch, the Informatics Program created a set of data resources, protocol
design tools, and processes to support the management of NIDA's clinical research.
Through these tools, the Informatics Program facilitates the streamlining of start up,
maintenance and closeout of clinical trials.
The Clinical Data Repository and Clinical Trial Portfolio System (CTPS) provide central
stores of clinical data and study administration data, respectively. The data is
aggregated into business-area data marts of the Executive Information System (EIS). The
EIS supports the Branch's ability to monitor safety and efficacy in clinical trials as
well as reports characterizing trial operations and performance including cost, enrollment,
retention, and adherence to clinical trial project schedules. The Informatics Library
provides a standard set of case report forms, data dictionaries and other design tools
for new clinical trials. The Library facilitates the standardization and streamlined start
up of clinical trials.
The goal of the Clinical Trial Performance Payment task is to provide an automated process where proof of performance is established based on clinical and study management data, allowing approval of incremental funding for clinical projects. Incremental performance based funding provides performance incentives for clinical sites based on their achievement of predefined project milestones. Such incentives for the site help to ensure timely submission of data to the Clinical Data Repository, and potentially shorten the duration of a trial lowering overall costs while making data more quickly available for analysis of outcomes.
To learn more about DPMCDA's clinical research management, select from the following areas:
Informatics Library |
Clinical Data Repository | Clinical Trial Performance Payment (CTPP) |
Executive Information System (EIS) |
Clinical Trial Portfolio System (CTPS)
Informatics Library
The NIDA Clinical Trials Informatics Library application is an electronic library of Global Standards
and Templates for NIDA-sponsored clinical research trials. The Library provides a comprehensive
resource for NIDA Clinical Investigators, Study Coordinators, Scientists, and others, in the preparation
of clinical study materials for the NIDA Clinical Trials program. Through the use of standard
templates, the Library:
- Improve data quality
- Reduce study startup time and cost
- Facilitate the pooling of data from multiple studies
For additional details, contact the librarian at
global.librarian@imc.com.
Access Public Library Application.
Clinical Data Repository
The DPMCDA Clinical Data Repository (CDR) houses all data collected from clinical research
projects conducted by the DPMCDA, addressing the following challenges:
- Early evaluation of site-level fidelity to protocol data design, by checking interim data against
field-level format and content rules
- Access to any completed trial's final raw data (clinical and non-clinical), in one
consistent and secure database environment
- Transformation of protocol-specific format and content variations into one common data
model, to support single-point access to data across trials and development programs
- Controlled access to data
The CDR provides standards to be followed by Data Management Centers (DMCs) to maintain the highest
quality of data in support of clinical data management operations. It is continually updated as active
trials submit interim data, and is a source of information for clinical research, cross-study data sets,
and the Executive Information System (EIS).
In particular, the CDR supports secondary analysis of data from NIDA clinical research projects.
- Design of New Studies
The combined data sets may be used to perform power analysis to determine sample sizes in new
clinical trials. Subgroup analysis may identify populations of individuals who are more or
less likely to respond to treatments. Drug use patterns and treatment retention provide
invaluable information for study design to estimate dropout rates and fine-tune follow-up assessments.
- Historical Controls
The combined data set may be evaluated for use in studies that require a historical control. One benefit
of utilizing this database as a historical control is the need for fewer subjects in a clinical trial
without an active control group.
- Pharmacovigilance
Safety data from clinical trials can be evaluated in light of post-marketing adverse reaction data
submitted to the FDA via the MedWatch reporting process. Comparing clinical research data with
post-marketing reports provides an opportunity to detect important drug-event signals and interactions,
including drug-dose and drug-drug reactions.
For more details or to request secondary analysis, contact an administrator at eisadministrator@imc.com.
Clinical Trial Performance Payment (CTPP)
The CTPP system enables DPMCDA to pay clinical trial sites for their achievement of certain key milestones
that occur during the course of a clinical trial. This system supports the general DPMCDA business objective
of promoting site performance and documenting the distribution of funds. The system displays the milestone
achievement and budget details in a Voucher Audit form for performance fund approval by users. The approval
process is completed by routing a Voucher Audit form and the supporting data through a workflow where
approvers receive and subsequently act on assignments. A key feature of the CTPP is that it holds trial
stakeholders accountable for the data submitted to the Clinical Data Repository, therefore linking their
payment to the accumulation of key data needed to determine study outcomes.
For more details, contact NIDA Livelink Support at NIDALLAdmin@mail.nih.gov.
Executive Information System (EIS)
The web-based EIS integrates multiple streams of clinical trial data into dynamic reports for NIDA managers.
The application functions as a reporting and management tool that provides direct and navigable on-line
access to clinical information residing in the CDR. The system is specifically tailored to executives'
information needs so that informed business decisions can be made. NIDA executives and managers can
monitor specific clinical projects, the performance of clinical research groups, and investigational
sites. The reports are grouped into three business areas:
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The Clinical Trial Study Management (CTSM) business area provides a view of data
management operations and performance associated with each clinical trial from
pre-enrollment data management center certification through study close-out.
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The Enrollment business area presents data on study enrollment progress and demographic
characteristics, viewed at a program level, per study, or at individual sites.
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The Safety business area presents data over the course of the clinical project and
allows for analysis of adverse events across projects and treatment groups, by severity and relatedness.
To obtain an EIS account or support, contact an administrator at
eisadministrator@imc.com.
Clinical Trial Portfolio System (CTPS)
The Clinical Trial Portfolio System (CTPS) provides a means to identify, track, and
report details on DPMCDA funded clinical research projects. At the highest level, CTPS:
Provides a tool to manage NIDA's clinical research portfolio by:
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- Identifying projects and studies
- Ensuring integrity of project/study metadata
- Verifying enrollment activities
- Ensuring FDAMA compliance
- Supporting tracking of staff and project/study assignments
- Providing auditing of user provided information
- Providing controls to manage NLM transmitted data
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Provides users a means to maintain quality metadata for clinical projects by:
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- Maintaining project and study status
- Tracking site level enrollment activities
- Tracking publications and scientific presentations
- Tracking project related regulatory information
- Collecting NLM and Clinical Data Repository required information
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Provides reports for users and system managers by:
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- Reporting project/study design information
- Reporting enrollment activities
- Reporting project/study conclusions and publications
- Reporting staff and project/study assignments
- Providing clinical project metadata for publication to the public
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