NCI Draft Statement of Need.pdf

DRAFT STATEMENT OF NEED (SON)

1.0 TITLE

Access to Database for Clinical Trials Information

2.0 BACKGROUND

Throughout the last few decades, cohort-based observational studies have helped researchers to better understand the complex etiology of cancer, and have provided fundamental insights into key environmental, lifestyle, clinical, and genetic determinants of this disease and its outcomes. More recently, the onset of the ‘omics age and precision medicine has compelled many Agencies and

Institutions to encourage collaborations across existing large cohorts. Such a collaborative approach enables the development of studies large enough to address the dynamic and interactive nature of the factors underlying common diseases. Since cohorts represent the cornerstone of the continuum from discovery to practice, this approach will also expedite translation by integrating data collected through the lifespan, in health and disease status, and providing a large framework for interdisciplinary research.

The Cancer and Data Science Laboratory (CDSL) was formed in early 2018 with the mission of developing and harnessing a broad spectrum of computational approaches for analyzing and integrating cancer omics laboratory and patient data. The CDSL will develop new, cutting-edge computational approaches and algorithms to this end, addressing fundamental research questions concerning cancer origin, evolution, progression and treatment, serving the cancer community at large. The lab will work in a highly collaborative and integrative manner with other Center for

Cancer Research (CCR) research labs to provide an analysis counterpart to their experiments and generate further testable predictions whose experimental outcomes could further feedback to the computations.

While there are tools and databases available (such as the NCI-sponsored Cancer Epidemiology

Descriptive Cohort Database (CEDCD) (Phase I)) for facilitating the identification of cancer epidemiology cohorts, the CDSL requires additional clinical trials datapoints than are captured in databases selectively inclusive of cohort-based observational studies. The CDSL requires access to a database which expands upon the limitations from systems focused solely on data from the CEDCD-supported and collaborating cohorts in order to facilitate the development of collaborative projects, accelerate research, and expand access.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The primary objective of this project is secure access to a clinical trials database that links data from reported clinical trials for studies around the world with the maximum access to studies spanning all

DRAFT STATEMENT OF NEED (SON)

types and phases of clinical trials datasets. Of particular importance is access to oncology trials including data for the clinical trials included treatments, design, and results information.

This database must include a user interface that enables users to download information for thousands of trails for each download. Updates to data contained in the database must be at a minimum once every weekday defined as Monday through Friday weekly. Finally, there should be user support for the database available to ask any questions regarding the data contained in the database with a real-time responsiveness.

Additional requirements for consideration are databases which support identification of biomarker data while supporting a robust range of trial result fields. The offered product should not be in a development phase and must support user-submitted debugging requests as well as requests.

Access to datasets beyond oncology specific trails would be considered optimal and extra points will be assigned to databases which have a wider range of clinical trials datasets available, have been utilized in analysis projects for groups which have acknowledged use of this database in their peer-reviewed published manuscripts (required as some databases limit publication rights in a way that not acceptable for the requirements for this program).

4.2 DELIVERY / INSTALLATION

The government point of contact for this Order will be determined upon award.

4.3 TRAINING

Demo/training for product must be conducted within 10 business days for contract award unless waived in writing (email reply to the notice for user licensee activation) from the Contracting

Officer.