The collection and use of samples must support science by shifting from a focus on primarily operational and in-house sample inventory management activities (i.e. hoarding samples) to driving deeper scientific insights by encouraging the optimal use of samples. Linking biospecimens with patient clinical and molecular data as well as patient consent and tracking samples across the full lifecycle of a study is now critical. Several key components must be established in a holistic informatics solution in order to improve clinical trial sample and consent tracking.<\/p>\n

There has to be an effective sample collection plan detailing the samples to be collected from patients at various times as determined by experts, including the principal investigator for the clinical trial. This plan must address important areas, such as which samples and for which assay types need to be collected at each visit, which shipping and processing facilities these samples will go to and what actions (processing, assay, storage, etc.) will be performed on the samples at each site, lab or facility.<\/p>\n

It is critical to compare and reconcile the samples that are collected against the sample plan to determine which samples have actually been collected and processed. This would include the identification of which samples have been collected or created (including sample derivation\/lineage information) at each site, central lab, testing lab and storage facility; which samples have been shipped from each facility to each intended location; and which samples were actually received at each facility.<\/p>\n

Another key component is the tracking of individual patients\u2019 consent responses for how biological samples and derivatives can be used in a specific clinical study and beyond. Furthermore, as set by the study team and sites, standard consent parameters\/ restrictions must be incorporated into computable data elements. In doing so, stakeholders can then reconcile these data against a particular patient\u2019s consent responses to derive the allowable use for each donated sample. Information regarding patient consent must:
\n\u2022 detail any consent restrictions at the study and site levels;
\n\u2022 identify any additional country or regional restrictions;
\n\u2022 determine which patients have signed which form of consent (both mandatory and optional); and
\n\u2022 determine which consent version applies to each collected sample.<\/p>\n

This information must also allow stakeholders to determine allowable uses for the samples from each patient (both for the ongoing study and future use), including what types of additional testing are allowed for study.<\/p>\n

In an effective sample collection plan, detailed information regarding collection progress can be held against the sample collection plan, and clear insights into the parameters of consent regarding each sample can be noted. Through a strategic plan, study teams can receive reconciliation reports that enable them to monitor the health of the trial from a sample-centric perspective, and when required, intervene in a timely fashion to improve trial quality and shorten trial time.<\/p>\n

From an informatics perspective, the main objective is to be able to acquire, standardize and combine the multitude of study data sources (e.g. study protocol, ICD, IVRS, IWRS, EDC, sites, central labs, test labs and storage facilities\/biobanks) from clinical trial stakeholders and partners. Once this has been done, meaningful calculations and additional business intelligence can be derived from these various data elements. This approach provides all stakeholders in a clinical trial the ability to promptly identify any issues regarding the collection, storage, shipping, handling, consent or testing of samples across an increasingly complex and distributed ecosystem to efficiently monitor and manage the health of their clinical trial and optimize the use of biospecimens in their clinical research.<\/p>\n<\/div><\/section>
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