A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, including preclinical development. To both streamline review of submissions and support pharmacovigilance, the FDA will likely start requiring preclinical data to be submitted in CDISC-SEND format in 2017. At the same time, there is an increasing trend of pharma companies outsourcing their preclinical research to CROs. The combination of greater regulation of preclinical data submissions and heavy reliance on CROs makes having an efficient data infrastructure more important than ever.
Bottlenecks in data access and analysis
Pre-clinical scientists frequently have two major challenges associated with being able to use their data to answer important scientific questions. First, data are usually stored in different systems. Second, applications used to capture and store scientific data often have only basic, fixed data query mechanisms that users cannot customize for data analysis. Providing scientists with access to project data and tools to analyze and collaborate is vitally important to improving the effectiveness of rational, data-driven research.
Scientists often rely on an already overtaxed IT department to get access to their data because of the complexities in data querying and reformatting that were required to generate research-relevant data sets. This bottleneck in data access and analysis can cause scientists to use out-of-date data views that impinge on their ability to work efficiently and accurately. An ideal solution should provide users constant access to their data while being straightforward to administer and maintain.
An inability to monitor in-real time outsourced studies
Drug development organizations commonly partner with CROs on preclinical drug development. Study data from CROs are delivered over the course of a study, typically in the form of data files in a variety of formats. Every time the CRO sends updates regarding a study, scientists at the sponsor company must spend time tediously merging, formatting, and otherwise manipulating the data files in order to get the whole view of how the study is progressing. This error-prone manual process can delay making important study-related decisions by days or even weeks.
In addition, CROs frequently employ different naming conventions for the same biological phenomena. For example, one CRO might use the term “leukocytes” whereas another refers to “white blood cells” or “WBCs.” These inconsistencies in terminologies make comparing preclinical studies an extremely difficult task involving lots of manual copying and pasting of data. Thus, scientists might miss subtle trends (control group drift, unexpected toxicity, etc) that could inform either altering or stopping a study mid-course.
Difficulties in managing CDISC-SEND formatted data
CDISC— the Clinical Data Interchange Standards Consortium— is a non-profit group whose mission is to develop and support global data standards to improve medical research and related areas of health care. Their preclinical data standard is SEND— the Standard for Exchange of Nonclinical Data. SEND data are generally comprised of a set of SAS transport files.
More and more organizations are using the SEND data standard because it offers significant advantages over other data formats. It is organized as a set of interlinked domains that provide information about the study, subjects, treatments, and results. SEND also provides standardized terminology. While this is a very rich format for information, it is also harder to manage and analyze this format compared to tabulated Microsoft® Excel® spreadsheets.
Learn more about scientific informatics solutions
I co-presented with Certara’s Dr. David Lowis, the webinar, “Managing Pre-clinical Study Data as a Strategic Asset.” Watch it to hear how a holistic approach can deliver business value and competitive advantage and provide rapid insights that let you anticipate and respond to regulatory questions and accelerate promising programs or stop unproductive ones more quickly so you can get your product to market faster.