We have supported and collaborated on over 55 Phase 1, 310 Phase 2, and 123 Phase 3 clinical trials. Most of which are government funded. Several FDA indications for Paclitaxel, Bevacizumab, and Topotecan for Ovarian and Cervix cancer were based on trials which we had biostatistics, data management, and QA responsibility.
The CTDD started as the Buffalo Statistics and Data Management Center in the early 1970s as the National Cancer Institute funded Statistics and Data Management Center for the Gynecologic Oncology Group (GOG).
The Clinical Trial Development Division (CTDD) of Roswell Park Comprehensive Cancer Center offers an experienced team that provides core clinical trial services. Our functional areas include clinical trial management, biostatistics, statistical programming, data management, software systems development, quality assurance
We are part of the Department of Biostatistics and Bioinformatics Department and leverage the expertise in many other Divisions spanning statistical genetics, genomics, and bioinformatics.
We have worked with GOG investigators and clinical sites in North America, Europe, Australia, Israel, and Asia
Supporting a portfolio of multi-center clinical trials requires an extensive amount of 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.
The Data Management Team is comprised of experienced Clinical Data Managers (CDM) who are committed to providing high quality data for statistical analysis. The CDMs are active members of the study team from development until study close-out. This end-to-end involvement enables the team to meet high standards in regard to overall data quality.
CTDD's Biostatisticians have designed, reviewed and analyzed many preclinical, clinical, and epidemiologic trials for various disease settings and outcomes. CTDD Biostatisticians perform statistical analyses of clinical trials and correlative research studies and ensure that all analyses are done in a statistically and scientifically sound manner.
The CTDD has an established audit program that operates in compliance with the guidelines of the Clinical Trials Monitoring Branch (CTMB) of the National Cancer Institute (NCI). The audit program ensures compliance with good clinical practice (GCP), human subject protection (HSP), federal regulatory, and National Institutes of Health (NIH)/NCI/Division of Cancer Prevention (DCP) policies and requirements.
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. 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.
