Brand Name Justification.pdf

PDF 85 KB Posted

Attached to
TrialTrove Software Subscription Federal contract opportunity
Solicitation number
75N98026Q00035
Issued by
Department of Health and Human Services Office of the Assistant Secretary for Administration

About this file

This is a Brand Name Justification document submitted by the National Cancer Institute (NCI) to support a sole-source procurement of TrialTrove, a commercial subscription-based software service providing access to a curated global clinical trial database.

TrialTrove is used by NCI's Cancer and Data Science Laboratory (CDSL) to conduct large-scale analyses of oncology clinical trial design, examining historical, current, and future trial design methodologies to advance cancer research. The platform offers sophisticated querying and analysis capabilities across clinical trial attributes including disease indications, treatments, trial phase, sponsors, eligibility criteria, endpoints, outcomes, and timelines. It provides curated narratives of trial results and cross-references to original source materials, enabling researchers to validate and contextualize data—capabilities unavailable through publicly accessible clinical trial databases. The justification emphasizes that CDSL has made substantial multi-year investments in internal analytical tools, workflows, and research methodologies specifically designed to operate on TrialTrove data, including both current data analysis and static data snapshots ("freezes") for reproducibility. Transitioning to an alternative commercial product would require significant redevelopment of these tools and analytical processes, substantially disrupting ongoing research activities. These factors support the justification for brand-name sole-source procurement rather than competitive solicitation.

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Other files attached to TrialTrove Software Subscription, newest first.
File Type Posted
RFQ 75N98026Q00035.pdf PDF
Attachment A - Statement of Work (SOW).pdf PDF

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BRAND NAME JUSTIFICATION

The brand being purchased is TrialTrove, also referred to as Trialtrove. TrialTrove is a commercial, subscription-based software service that provides access to a curated database of global clinical trial information.

TrialTrove is used by The Cancer and Data Science Laboratory (CDSL) at the National Cancer Institute (NCI) to conduct large-scale analyses of oncology clinical trial design. CDSL’s research focuses on understanding how cancer clinical trials have been designed historically, how they are currently designed, and how future trials may be designed more effectively to advance cancer research. The TrialTrove platform supports clinically oriented research that cannot be performed using publicly available or less comprehensive data sources.

The TrialTrove database enables sophisticated querying and analysis across a wide range of clinical trial attributes, including disease indications, treatments, trial phase, sponsors, eligibility criteria, endpoints, outcomes, and trial timelines. TrialTrove also provides curated narratives of trial results and cross-references to original source materials, allowing researchers to validate and contextualize trial data. These capabilities are critical to CDSL’s mission and are not available through publicly accessible clinical trial databases.

The program has made substantial, multi-year investments in internal analytical tools, workflows, and research methodologies that are specifically designed to operate on data extracted from TrialTrove. These tools support both small-scale analyses using current data and large-scale research projects based on static data snapshots, or “freezes,” to ensure reproducibility and consistency of results. Transitioning to an alternative commercial product would require redevelopment of these internal tools and analytic processes and would significantly disrupt ongoing research activities.

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