September 21, 2022 — Biospecimens collected as part of biomarker-informed clinical programs are precious resources for precision medicine research and development (R&D). However, the complexity of tracking and linking informed consent data at the sample and derivative levels limits the use of these biospecimens.
Most informed consent data exists in uncodified informed consent forms (ICFs) and ends up in silos spread across multiple databases. It can be manual and time-consuming to compile information and surface insights.
In this post, we’ll explore how clinical teams can benefit from QuartzBio’s flexible approach to ICF codification to reduce complexity, gain more value from their stored samples, and help turn their biorepositories into drug development engines.
The Challenge: Siloed, Uncodified ICF Data
The challenge many sponsors face is not one of quantity. Instead, it is one of complexity. Sponsors may have many thousands of biospecimens from many different clinical trials sitting in multiple long-term storage locations, each having varying ICFs and sample destruction dates. This makes it difficult for clinical teams to address questions such as
- “Which FFPE samples in Biorepositories A, B, and C are consented for genomic analysis?”
- “Which samples will be destroyed within the next 6 months per sample destruction date listed on the ICF?”
- “Which samples need to be destroyed because the subject has withdrawn consent?”
The Approach: Tailored, Sponsor-Centric ICF Codification
The ideal virtual biorepository is a searchable master inventory of the vast array of samples from both open and closed clinical trials. With this much data on hand, R&D teams must be able to search and filter that inventory based on consent data fields such as:
- Consent status – including withdrawal of consent
- Consent restrictions and approved uses
- Sample destruction date based on ICF linked to sample type
- Links between multiple different ICFs (for example, a master ICF, future-use ICF, and a genomics ICF for subset of samples) at patient, site and country levels
In addition to these critical types of consent data, QuartzBio clients often seek to interrogate and visualize ICF data to suit specific applications. For example, a client may wish to explore codified ICF data linked to appropriate sample type, with parent/child linkages, filterable to find samples of interest, annotated with approved and restricted use cases.
By linking biospecimen metadata, informed consent, and biomarker data across multiple laboratory LIMS and inventories, clients can create a flexible virtual biorepository that is ready to use for a wide range of R&D needs.
The Results: More Codified Consent Data, More Power
Armed with a master inventory annotated with codified informed consent data, clinical and translational teams are empowered to
- Save resources and time, using stored samples to advance research beyond this current study
- Rapidly respond to requests for additional testing
- Ensure regulatory compliance with retention, use, and destruction requirements based on informed consent
- Facilitate efficient discontinuation or transfer of studies/programs
- Perform risk-based monitoring to determine, at a distance, whether every sample has an appropriate consent status
At QuartzBio, we deliver solutions that advance our clients’ pipelines today while remaining future-proof for tomorrow. This resilient approach is critical, especially in the face of evolving scales, regulatory requirements, and complexity of clinical programs.
QuartzBio is rigorous with regards to regulatory compliance, yet flexible to sponsors requirements, both in terms of which information to extract as well as how to visualize, filter, and search it.
Some sample inventory management systems are limited as to which data structures can be imported, or even place data structure requirements on vendors. QuartzBio technology maps data as-is, from any source, into the QuartzBio® Data Platform using the format provided by the lab, vendor, or other source system with no changes required. The result: increased flexibility and faster deployment.
Further, while some ICF codification solutions limit users to filter using 7-9 rigid terms, QuartzBio’s virtual Biorepository solution enables clients to configure the platform to enable filtering, searching, and visualizations using sponsor-defined parameters.
How is your team thinking about making the most of your biospecimens? Connect with the QuartzBio team to discuss the structure your consent data and get a closer look at the QuartzBio data platform.