ICON's Technology Solution to Improve the Management of Drug Development Programs

The pharmaceutical industry and contract research organizations (CROs) are increasingly adopting the use of technology to improve the process of clinical research. The drive to develop and adopt eClinical technologies is due to a number of factors, such as the pressure to increase drug research productivity while also reducing costs and the need for improved data quality. eClinical technologies, such as Electronic Data Capture (EDC), Interactive Voice or Web Response (IVR/IWR) Systems, Electronic Patient-Reported Outcomes (ePROs) and Electronic Imaging, provide a range of solutions to address the need for greater efficiency and productivity in the drug development process.

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Improving Compliance, Consistency, and Execution at Sites

On July 14, 2011 ICON announced the acquisition of Firecrest Clinical, a market-leading provider of technology solutions that boost investigator site performance and study management.

Firecrest Clinical provides a comprehensive site performance management system to improve compliance, consistency and execution of activities at investigative sites. The web-based solution enables accurate study protocol and case report form information and training manuals to be rolled out quickly and simultaneously to sites. Site behavior can then be tracked to ensure training is understood, procedures are being followed, timelines are met and study parameters are maintained.

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Online Hosted Medical Image Repository for Biomarker Research

The overwhelming majority of clinical trials are conducted as transactional research with little, if any, concerted effort towards building off the data collected in previously run trials. Within an indication, the nature of regulated trials is such that each subsequent trial phase must be guided by the prior trial phase, but how often do sponsors truly mine their historical data to better enable planning drug development?

This transactional approach is contradictory to what Morgan Stanley noted as "the ongoing shift in industry strategy towards a "Pharma 2.0 Model" in their Global Healthcare Outlook for 2011. The Pharma 2.0 Model is a paradigm shift from blockbuster products to targeted therapies and broad portfolios. This shift only strengthens the value of informatics for the industry as they struggle to mine existing data for targeted therapies and as they scour their broad portfolios to focus on those compounds with the greatest chance of success. Furthermore, the increasing cost of pharmaceutical development and decreasing return on investment is well documented. This inverse relationship has heightened the need to better understand the associated risk before the trial begins. In order to support this paradigm shift, industry members need to build and maintain clinical trial data repositories in their search for biomarkers.

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Drug Induced Liver Injury Detection in Clinical Trials

The 2009 FDA Guidance for Industry Drug-Induced Liver Injury (DILI) in premarketing clinical evaluation has had a significant impact on sponsors in the detection and management of elevated hepatic enzymes. Highlighted below are three pertinent extracts from the guidance.

DILI has been the most frequent single cause of safety-related drug marketing withdrawals for the past 50 years (e.g., iproniazid) and continuing to the present (e.g., ticrynafen, benoxaprofen, bromfenac, troglitazone, nefazodone). Hepatotoxicity discovered after approval for marketing also has limited the use of many drugs, including isoniazid, labetalol, trovafloxacin, tolcapone and felbamate.

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When Machines Talk: Speeding Phase I Trials with Electronic Data Capture

In the world of early phase research, is the Case Report Form (CRF) – yes, even the eCRF – going the way of public pay phones, encyclopedias, and floppy discs? Thanks to machine-to-machine communication in clinical pharmacology units, clinic staff no longer need to populate CRFs when conducting Phase I clinical trials. Readings from a variety of medical instruments and clinical systems can be transferred electronically to a data repository in preparation for analysis. In bypassing several time consuming and error-prone steps, this breakthrough promises to slash the number of data queries, speed study startup, inform early go/no-go decisions and reduce study costs dramatically

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Did you know?

• ICONIK, ICON's integrated technology platform, provides true data transparency throughout the management reporting and analysis of all data related to drug development
  • Easy access to study trends
  • Critical and more timely safety and efficacy information
  • End to end trail with full chain of custody
  • Fully '21 CFR Part 11' compliant auditable history

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