Clinical Trial Development Division

Broad expertise

Supporting a portfolio of multi-center clinical trials requires extensive oversight and coordination to maintain integrity and reliability of their results. A strong and high functioning central clinical trials coordinating center, with a high level of expertise and experience, is the cornerstone for supporting successful clinical trials. In order to accomplish the goals of a network, there is clearly a need for support, including logistical infrastructure and data management, scientific, statistical, and administrative expertise.

Without strong, experienced, and proven support on all these fronts, research results would be more difficult and costly to obtain, less reliable, less reproducible, and less easily disseminated. The CTDD brings all of this expertise through our core range of functional services and our team members.

Promote a culture of innovation across all functional units

Innovation is critical not only for efficiency improvements recognized by end users and developers but also for maintaining talent. The CTDD maintains a culture of innovation for staff engagement and retention, to strive for quality improvement and contribute to trial reliability, safety and integrity through increased efficiency. Innovations supporting NCTN clinical trials developed by CTDD staff cover areas of operational efficiency, quality assurance, statistical design, Medidata Rave® study build and quality management systems.

Guided by a robust library of Standard Operating Procedures and policies

A proprietary on-line SOP system was created to manage documents, on-line authoring and training. This system has been used by the CTDD and for NRG Oncology SDMC SOP management.

Protocol development

CTDD Data Managers are involved very early in the protocol development process. They collaborate with key members of the study team such as the Biostatistician and Study Chair or Sponsor to review and update the protocol document. This team approach ensures consistency of sections affecting data management processes such as eligibility, study calendar, forms due section, and overall protocol flow.

Data Management will collaborate with the Sponsor’s Interactive Response Technology (IRT) vendor to integrate the registration and randomization system with the selected EDC.

Case report Form lifecycle management

The CTDD has experience developing and curating standardized common data element (CDE) eCRFs and CDASH compliant forms for the collection of wide range of required assessments including dose-limiting toxicity assessment, adverse events, and drug administration, among many others. Standardized forms can be developed using common data elements (CDE) from the NIH CDE repository or CDASH standard content from the Clinical Data Interchange Standards Consortium to ensure consistent data collection across studies and sites. Data Management can leverage the robust global library of case report forms which were created in accordance with the data standards mentioned above. CRFs will be supported by a comprehensive set of CRF Completion Guidelines which can serve as an aid to the partner’s sites during the data entry process.

Data integrity & quality control

The CTDD has a proven track record of providing comprehensive data management quality control and quality assurance programs to ensure high data integrity and timely data for analysis.

Statistical analysis & design

CTDD Biostatisticians design, review and analyze preclinical, clinical, and epidemiologic trials for various disease settings and outcomes. CTDD Biostatisticians provide collaborative support throughout the trial life cycle, including concept development, statistical design, protocol development, analysis of clinical endpoints, manuscript preparation and correlative research studies.

Innovation

The CTDD Biostatisticians collaborate with investigators on innovative study design and analysis of clinical trials and correlative science studies. The biostatisticians determine the appropriate and feasible hypothesis testing strategies and endpoints for meeting protocol objectives while maintaining power and trial integrity. The Biostatisticians work with information technology, data management and statistical programmers to ensure all results are collected and reported appropriately.

Statistical programming

The statistical programmers collaborate on standardized programming, data monitoring committee and regulatory reporting, and manuscript preparation. They assist in developing quality checks on incoming and outgoing data and prepare analyzable datasets for use by collaborators and external scientists. They also provide leadership in the preparation of summary reports and research results, including written explanations of methods and results, tabular and graphic displays of data, and documented computer code supporting repeatable research. They also collaborate in database design and project management.

Quality assurance

The CTDD quality assurance and reporting function promotes the highest level of scientific integrity and the protection of human subjects who participate in research studies. The quality assurance team has extensive expertise and experience in developing and performing comprehensive evaluations across a broad range of clinical research protocols.

The audit/monitoring program supports quality assurance objectives through examination of investigator performance in complying with protocol requirements, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP, as well as other applicable or specified regulations. The selection of quality participating institutions is an important strategy in protecting against poor adherence to protocol criteria and poor data quality.

Quality control

Quality control objectives are supported through processes which include protocol review, site education, identification/resolution of systematic issues, SOP development, etc. Education and training pertinent to overall processes, as well as individual protocols, is provided to participating institution principal investigators and research staff. This typically occurs by utilizing audits/monitoring to provide instantaneous specific educational information based upon deficiencies noted. The team also uses reviews as opportunities to share best practices observed across all participating institutions that may lead to improved performance. The interaction between reviewers and institutional research staff also provides valuable insight regarding systemic problems and/or proactive practices. This knowledge is incorporated into network-wide targeted educational programs or broadcasts. Flexibility and innovation are utilized to enhance and tailor processes to meet protocol requirements.

Corrective And preventative action

Experienced researchers oversee and manage the follow-up (corrective and preventative action) process to ensure that sites act on all significant findings of concern. Any irregularities identified through quality assurance and control processes that raise suspicion of fraud or intentional misrepresentation of data are immediately reported according to protocol directives.

The CTDD provides quality assurance and quality control systems to ensure that the highest level of quality data are generated, documented, and reported in compliance with the research protocol. A wide range of processes and activities across the four functional areas within the CTDD (Biostatistics and Statistical Programming, Clinical Trials Management, Quality Assurance and Reporting, and Information Technology) work in concert to monitor, ensure, and improve data quality and human subject protection.

Custom software development

We have extensive expertise in the development of transactional and large-scale database architectures to facilitate batch data analytics and real-time machine learning applications. This includes customized data warehouse design, ETL process design & optimization, application integration, server hosting & administration, and development of tailored APIs to support network/web-based access to hosted data.

Data and specimen sharing system

Developed systems to facilitate data and specimen sharing. The CTDD systems development team has worked with both NCI funded programs and industry partners to produce innovative systems for the efficient and secure exchange of data and specimens.