Are Data Standards on Your Radar Screen?

And will they affect your manufacturing processes?

The importance of standards is a fundamental concept within the realm of manufacturing, since the ability to successfully and efficiently engineer and produce a consistent level of output depends on having operational systems that apply precise specifications for component, quality and process standards. But the application of standards to clinical data is still a relatively new concept, largely because clinical research is typically viewed as a scientific exploratory process which should be specifically customized to meet the individual requirements of each unique protocol.

Fortunately, this attitude is beginning to change. Within the biopharmaceutical research community, the Clinical Data Interchange Standards Consortium (CDISC) has been facilitating development and adoption of data standards in Clinical Research for more than eight years. These efforts have resulted in the creation of a core set of production data standards that are rapidly growing in use throughout the industry, and have helped catalyze a number of other collaborative efforts to define standards that will promote interoperability among systems used by multiple government, research and commercial participants. While the impact of these clinical data standards may be currently outside the purview of many of those whose principal focus is on pharmaceutical manufacturing, it’s very likely that the future implications of these activities will extend throughout the industry.

CDISC is an open, multidisciplinary, non-profit organization committed to the development of global, vendor-neutral, platform-independent standards for biopharmaceutical clinical trials data and metadata. Initially founded in 1997 by Dr. Rebecca Kush and others as a grass-roots collaboration of interested individuals, CDISC became a non-profit organization in 2000, and is now supported by funding provided from more than 170 sponsor and member organizations. CDISC has active participation throughout the United States, Europe, Japan, and other regions.

The scope of CDISC was initially focused on defining new data standards to support the electronic acquisition, exchange, submission, and archiving of clinical trials data, primarily in commercially-sponsored studies. However, as progress has been made within this original scope, CDISC has recognized the importance of collaboration and has expanded into many other research-related areas, which has since led to involvement in dozens of other active projects. As its reputation within the area of biopharmaceutical clinical data standards has grown, CDISC has taken a role in broader-based standards activities, including participation in committees contributing to the U.S. Government’s Consolidated Health Informatics initiative (CHI), which is driving momentum toward creation of interoperable health data systems and electronic health records.

CDISC Production Data Standards
CDISC currently has six production-level standards that are published for implementation by the clinical research community. Some of these standards are published as informative guidelines only, whereas others include a fully normative representation such as an xml schema. These standards fall into two categories: Operational Standards used during the conduct of a study and Submission Standards used to represent data sent to the FDA (and potentially other regulatory authorities) as part of product marketing applications. Use of the CDISC SDTM and Define.xml submission standards, for example, are specified in the FDA’s current guidance for submissions using the electronic Common Technical Document (eCTD).

Readers may be particularly interested in the CDISC Laboratory Model (LAB), which was defined as a standard representation for transmission of lab specimen results from a laboratory information management system (LIMS) to a pharmaceutical sponsor or physician. The CDISC LAB model has also been approved as an ANSI-accredited HL7 standard, and is now being adapted for additional laboratory applications such as genomics and microbiology.

Another important CDISC standard is the Study Data Tabulation Model (SDTM), a standardized representation for clinical trials observations using a set of standard data variable names and table structures. Although the SDTM was originally designed primarily for use on human clinical drug trials, its flexible, extensible concepts have proven to be suitable for use with non-clinical animal data and are being applied for use on genomics data observations, device trials, etc. Use of the SDTM is rapidly gaining traction among FDA, pharmaceutical sponsors and other research organizations such as the United States National Cancer Institute (NCI) as a standardized way to describe data typically collected on Case Report Forms (CRFs).

Implications for Pharmaceutical Manufacturing
Although CDISC has not been working directly within the realm of pharmaceutical manufacturing to date, it’s useful to become familiar with these standards-related activities because of their potential future implications. For example, the emerging HL7 standard message for representing drug product stability information is likely to be directly of interest to those involved in drug product manufacturing, and those involved with laboratory or ECG systems should become familiar with the CDISC LAB standard and the annotated ECG. And several CDISC controlled terminology standards are likely to be used outside the boundaries of pure clinical data collection, such as drug ingredients, formulations and dosage units. As these standards take hold, they will increasingly comprise the lingua franca of clinical research and are likely to affect to some degree nearly everyone who’s involved in pharmaceutical and health industries.