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International Clinical Trials

Intelligent Interface

Ed Krasovec of STARLIMS Corporation explores the future of clinical trial laboratory information management systems

Falling productivity and rising costs have intensified the pressures on pharmaceutical clinical development processes, propelled the growth of CROs, and consequently increased the demands on the informatics solutions used by sponsors and CROs for planning and executing clinical trials. With laboratories playing a vital role in the majority of clinical trials, laboratory information management systems (LIMS) are a crucial component of the clinical trials informatics landscape.

A web-based clinical trial LIMS can act as a scalable and comprehensive solution that provides secure and direct global access to central lab operations information for key stakeholders, including clinical trial investigators, project managers, kit manufacturing sites and external reference labs. Integrated web-based LIMS solutions can advance clinical trial execution toward a future state of improved efficiency and reduced costs by including:

  • ‘Closed loop’ tracking of kits and clinical trial specimens
  • Pre-accessioning of clinical trial specimens
  • Real-time tools to identify and properly manage high-value biomarker specimens
  • Integrated biorepository capability for the management of stored samples to help current and future research
  • Management of documents and files created as part of the clinical trial and automated extraction of key unstructured data from them
  • Operations and data management tools to administer and seamlessly harmonise the data produced by a global network of clinical trial laboratories

CLOSED LOOP MANAGEMENT OF KIT AND SPECIMEN LOGISTICS

With the cost of obtaining a valid clinical trial specimen ranging from $100 to over $2,000, effective specimen management is essential. A web-based clinical trial LIMS provides the advantage of easy access to information for all stakeholders, including personnel involved with collecting and shipping the specimen at the clinical trial site. By providing investigators with secure web-based access to the LIMS, online tools for ordering kits and supplies can be made available. In addition, logistics personnel can track the investigator site’s inventory of kits and other supplies. This visibility allows the clinical trial logistics team to take action (transfer supplies, optimise existing inventory, or provide suitable handling alternatives) to prevent problems that can be created when samples are collected and shipped with the wrong containers and materials.

As an example of this increased visibility, the user interface can include a personalised dashboard that dynamically displays alerts and reminders for kits and kit components approaching their expiry dates, kits with low stock levels and statistics on inbound shipments. This dashboard can also include reminders for pending tasks and key performance indicators – including graphical display of important summary statistics and trends.

Furthermore, the investigator’s LIMS functionality can be configured to include a simple tool to document outgoing shipments by linking the kit IDs in the shipment to the courier airway bill number. This can greatly improve the central laboratory’s visibility and awareness of incoming specimen load. It also provides traceability to any quality issues that may arise during shipment and handling. By making this link at the time of shipment from the investigator site, the aspiration for real-time closed loop status/tracking on incoming specimen shipments can become a reality through the use of a web services interface between the clinical trial LIMS and the courier tracking systems.

PRE-ACCESSIONING: A VIEW TO THE FUTURE?

To further expand on this vision, browser-based clinical trial LIMS investigator functionality can also be leveraged to provide the opportunity for pre-accessioning of the specimen using trial and visit specific electronic requisition screens. These would enable investigator site personnel to electronically document the requisition data immediately after collection of the samples. The electronic requisition screens can include validation logic that immediately alerts data entry personnel to suspect data and therefore reduces data entry inconsistencies. An absurd date of birth or a gender that is inconsistent with the last patient visit would be flagged immediately. It is unlikely that all clinical trial sites would be willing to utilise this capability – but consider the benefits if even a few high-volume clinical investigator sites were to use the pre-accessioning capability. Under this scenario, the accessioning process at the central laboratory would be streamlined significantly, with the focus shifted from data entry to simple documentation of specimen receipt and condition, and validation of requisition data.

Any potential discrepancy or query that may have an impact on the validity, availability or quality of the data generated in the laboratory must be identified, investigated and resolved as a matter of extreme urgency. By providing LIMS access to the clinical trial investigator site, many queries can be avoided, and those that do occur can be identified and resolved quickly. The sooner an effort to address inconsistent or missing data is initiated, the better the chances are that the investigator site personnel will be available and will remember important and relevant information.

MANAGING HIGH VALUE BIOMARKER SPECIMENS

Personalised medicine, or pharmacogenomics, is the prescribing of drugs based on a patient’s individual biological profile and relies on valid biomarkers that pinpoint which drugs a patient should receive (1). Often, large groups or cohorts of patients or specimens are needed to prove the safety and efficacy of the drug or to locate specific DNA sequences of disease states.

We have seen how allowing investigator access to the LIMS can improve the management of both specimens and clinical trial data for the clinical trial laboratory. Now we can look further to see how this can provide rules-based analytical tools to screen incoming specimens and identify high-value biomarker specimens. A configurable clinical trial LIMS can apply rule-based logic to alert the investigator site personnel to capture the specimen and any important ancillary data, obtain patient consent, and provide instruction on appropriate sample handling and shipment procedures. In addition, such a system will help close the loop by alerting investigator services personnel about the incoming specimen and managing the logistics related to shipping the specimen to speciality reference laboratories. Furthermore, the LIMS should include tools that easily consolidate assay results from internal laboratories and multiple speciality reference laboratories.

BIOREPOSITORY-SPECIMEN STORAGE FOR CURRENT AND FUTURE USE

In March 2009, biobanks made Time magazine’s list of ‘Ten Ideas Changing the World Right Now’(2). A modern clinical trial LIMS must have integrated biobank/biorepository capability. An integrated biorepository provides tools to locate, store, ship, receive, manage chain of custody, and test biological specimens, not only to enforce the storage and testing requirements of a current clinical protocol but also to support future research. With access to a graphical browser interface and configurable query templates, researchers should be able to query the system to find specimens that may be helpful to future scientific investigations.

All sample information, such as quantity, quality and storage location should be captured in the clinical trial LIMS biorepository system. The biorepository must manage the logistics related to storing the specimen under the appropriate conditions and of moving them to the correct laboratory location at the right time to allow timely testing of the specimen before viability expires. The system must also manage the patient consent status for each specimen.

It is vital that the clinical trial LIMS biorepository provides decision support for effective storage utilisation, including tools to plan and track the capacity in each storage location, consolidate inventory within a location, and proactively remind personnel to perform periodic physical inventory reconciliation.

SMART DOCUMENT AND FILE MANAGEMENT

Clinical trial operations personnel have a multitude of documents and files that must be managed, including scanned requisition forms, laboratory services agreements, FDA 1572 forms, SOPs, and a variety of technical reference documents, manufacturers’ monographs, and scientific articles. An integrated document management system can provide a secure storage repository for these documents and files, and can link them to the appropriate data objects, including the clinical trial itself or a specific clinical trial accession or site. An integrated scientific data management system (SDMS) can offer a powerful content acquisition capability that uses unique artificial intelligence algorithms to process unstructured data from documents in an automated manner. Documents can be routed to a workflow either automatically or manually by attaching a document to a specific workflow ID. The SDMS can extract content from the document, and as part of a configurable workflow, can automatically create the appropriate data within the database. It is then possible to use the SDMS to parse a clinical protocol or data management agreement document and to automate the data entry related to building a new clinical trial record. Consider the operational efficiency advantages of using such a ‘smart’ protocol document to autoload clinical trial definition parameters into the LIMS.

MANAGING A GLOBAL NETWORK OF CENTRAL LABORATORIES

A global clinical trial often involves using a network of internal CRO/central lab sites, as well as third-party local laboratories, to ensure prompt specimen processing and test result turnaround times. The clinical trial LIMS must help manage the harmonisation of laboratory result data, regardless of testing location. For the internal laboratories, this can include managing periodic internal and external proficiency surveys, as well as tracking daily QC data. For the third-party local laboratories, this can include passing the laboratory result data through a data harmonisation algorithm and managing periodic audits and certification agreements.

The LIMS must support electronic acquisition of results from a third-party laboratory through a traditional interface using HL7, web services or flat file transfer. This capacity can be expanded with a SDMS. As an alternative to a traditional interface, and to lower the barrier for electronic capture of external laboratory results, the SDMS can parse the electronic reports generated by the third-party local laboratories in PDF, Word or other formats, and store the test results and other related information in the database. The SDMS provides artificial intelligence capabilities that enable parsing templates to be created without the need for programming knowledge from the user. This allows electronic acquisition of the external lab data into the LIMS, providing more immediate visibility of laboratory results to all stakeholders, and eliminating possible transcription errors.

CONCLUSION

The LIMS plays an important role in managing the execution of a clinical trial. A successful and future-proof information management solution for clinical trials should provide secure and direct access to information to key stakeholders on a global level – and the use of web technologies is essential in creating this type of visibility. Other important factors in a clinical LIMS include comprehensive tracking of kits and specimens, pre-accessioning capabilities, biomarker management, biorepository capabilities and consolidated management of multiple types of documents and files. Altogether, a successfully integrated web-based clinical trial LIMS can deliver improved efficiencies and reduced costs – while addressing the ever increasing-needs in the pharmaceutical development process.

References

  1. Bouchie A, Cancer trials get set for biomarkers, Nature Biotechnology 22: pp6-7, 2004 
  2. Park A, Ten Ideas Changing the World Right Now, Time Magazine, 2009

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Ed Krasovec is the Director of Clinical Operations for STARLIMS Corporation, an Abbott Company. He oversees business development, implementation and product management for clinical laboratory information management applications including clinical trials, biorepositories and healthcare. He has spent the last 10 years building LIMS and other clinically oriented informatics businesses. Ed holds a BSc in Chemical Engineering and an MBA from Drexel University.
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