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 Set-Up (CTSU) 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.

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) | Data Sharing | Clinical Trial Set-Up (CTSU)

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:

• 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.
• The Enrollment business area presents data on study enrollment progress and demographic characteristics, viewed at a program level, per study, or at individual sites.
• 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.

Data Sharing

"NIH reaffirms its support for the concept of data sharing. NIH believes that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. The NIH endorses the sharing of final research data to serve these and other important scientific goals. The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers."

See (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html )

DPMC will make available data sets for studies for which the data has been locked for more than 18 months or when the study has released its primary publication.

This page displays the list of studies that will have data available for public use by researchers. As a study is completed and its data become available, it will be included on this page. The following will be posted per protocol:

1. Data set
2. Case Report Forms
3. Data Dictionary
4. Study protocol documentation and notes
5. Reference to Study Publication of primary outcome

Studies available for data sharing:

Access Data Share Website

Clinical Trial Set-Up (CTSU)

CTSU is an application used to provide NIDA DPMC's supporting contractors a means to gather, enter, store and retrieve data needed to manage clinical research projects and provide source data to other informatics program applications and systems. Data about NIDA-sponsored clinical research programs is periodically transferred to NIDA DPMC for entry into the Protocol Registration System and published on the ClinicalTrials.gov website.

Provides a tool to manage NIDA's clinical research portfolio by:

• 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

Provides users a means to maintain quality metadata for clinical projects by:

• 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

Provides reports for users and system managers by:

• 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