Saving Time and Money

What was travel like without the ATM machine or the ability to use credit and debit cards? It required much more in terms of advanced planning to obtain traveler's checks or the proper currency for the countries we visited. Now, we simply board a plane, land in an airport, seek the ATM machine, and use our cards to withdraw monies in the proper currency from our own account even though we are in a different country. In this example, industry standards allow travelers to easily execute financial transactions in real time.

What if it were possible to easily exchange one of the greatest assets of medical research—the information or data—with different partners and service or technology providers? What if that data could be integrated into a knowledge warehouse that would provide information on the safety and efficacy of pharmaceutical products, pre-approval through postmarketing? What if the U.S. FDA could query a cross-trial database to compare baseline and safety and efficacy information across products in the same therapeutic area so that fewer placebo subjects would be required per study?

These examples highlight the power of data interchange standards to save time and resources and reduce clinical study costs. An even more precious value would be the ability to readily access aggregated, de-identified information from different sources and improve the quality of health care.

PHOTOGRAPHY: PHOTODISC ILLUSTRATION: PAUL A. BELCI

Standards in motion

For the past decade, the Clinical Data Interchange Standards Consortium (CDISC) has been working to achieve this vision by developing standards to support the acquisition, exchange, submission, and archive of research data and metadata.

The Operational Data Model (ODM) can carry case report form (CRF) data along with a complete audit trail and provides an archive format that does not require mothballing systems to retrieve in the future. ODM supports all regulations for electronic record keeping and can create eCRFs in minutes.

The Study Data Tabulation Model (SDTM) describes the organization, structure, and format of standard clinical trial tabulation datasets and is listed as a data specification, referenced in FDA Final Guidance for eSubmissions (implementation of the eCommon Technical Document).

Specific benefits from CDISC standards

Despite known improvements in clinical trial performance through use of CDISC standards, companies still need information on the business case for standards adoption. In order to provide that information, Gartner and CDISC conducted research that was supported by PhRMA during 2006.

The Business Case Project findings indicate that CDISC standards can result in resource savings of as much as 60% overall for a single clinical research study and 80% in the start-up stage (see Table 1).

Table 1. Time and cost savings realized when CDISC standards were implemented.

The resource savings were gleaned from extensive interviews with 35 individuals from 22 companies in the United States and Europe. It should be noted that these savings have been applied to baseline data from industry averages for benchmark studies. Should a company wish to determine potential savings for one of their studies, it will be most prudent to use their own baseline metrics and apply the given percentages (omitting the protocol-based patient participation time). To gain these savings, they must also implement the standards up front, at least in the protocol through CRF design stage. In other words, with respect to time and cost savings, an individual company's baseline cycle times, costs, current use of standards, and rate and means of implementation will drive their return on investment.

Figure 1. Cycle time savings with CDISC standards.

In addition to, and perhaps of even greater value than, the reduction in cycle time and resources (see Figure 1), companies that use CDISC standards report the following benefits:

• better communication among team members and across departments

• facilitated transfer of data among partners (investigative sites, CROs, merger partners, technology providers)

• higher data quality

• the ability to plug and play different technologies and applications that conform with industry standards.

Potentially even more valuable than the direct savings in time and cost are the qualitative benefits from using the CDISC standards to facilitate integration. When data are integrated and used to populate a data warehouse, it can:

• enable better trial design for the future by reusing existing information

• provide faster responses to regulatory questions and facilitate regulatory reviews

• facilitate detection of safety signals

• potentially answer questions about products without doing further postmarketing studies.

The Business Case report not only delineates the benefits of the standards but also elaborates best practices and recommendations for developing an implementation strategy. More information on implementation metrics would be helpful, but at this point the business case is sufficiently compelling. Most companies are not asking whether they should implement CDISC standards, but when they should begin implementation. In addition, a proposed rule by the FDA is expected to require electronic submissions in the near future. The CDISC standard is specified as the desired format.

So, which organizations need industry standards? The sidebar below (Do You Need Standards?) provides a handy guide companies can use to determine whether implementing standards will provide them with a return on their effort.

Do You Need Standards?

Implementation tradeoffs

There are implementation tradeoffs that each company will need to consider as it develops its plans. Some companies may be tempted to convert their data into the CDISC standards as they prepare the regulatory submission. However, there are significant costs to map to a submission standard at the end of a study. A company that chooses that approach limits the value it could accrue employing the standards in earlier stages of clinical study, such as protocol or CRF design. In addition, it loses the strategic value of implementing CDISC standards—access to electronic health record (EHR) systems for research purposes and safety surveillance is supported through the CDISC standards as a link between medical research and health care.

Of course, if standards are implemented throughout the entire process, this may have a major impact on companies that already have consistent internal standards. Each company will need to determine its own current status with respect to the incorporation of proprietary standards within their process and tools that have been programmed to work with these proprietary standards.

Companies that have not yet adopted any standards will clearly have a lower implementation cost when adopting industry standards. Table 2 presents the implementation tradeoffs for each of the four stages of clinical study, from startup through regulatory submission. There is additional information in the Business Case report to assist companies in decision making for implementing CDISC standards, based on their current status with respect to the use of any standards.

Table 2. The tradeoffs for companies that do not implement standards and those that do.

Key messages for leaders

In summary, certain messages emanated from the Business Case that are key for leaders in clinical development:

• The value of standards extends far beyond process efficiency.

• Standards save time and money, especially when implemented in the study startup stage.

• Organizations are becoming proactively compliant with CDISC standards.

• Harmonization of standards across clinical research and with health care is a core strategic goal that would streamline investigator participation in research by focusing on entering data once for multiple purposes.

Accessing the Business Case report

This article is a glimpse into the information on the Business Case for CDISC Standards. The complete presentation report is posted on the CDISC Web site [www.cdisc.org] in the Members Area, along with a Gartner summary of the CDISC Business Case "CDISC Standards Allow Reuse Without Rework."

The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health care. Adoption of clinical data standards will bring the biopharm industry closer to the goal of improved medical research.

Carol Rozwell* is vice president & distinguished analyst with Gartner, (508) 651-9806, email: carol.rozwell@gartner.comwww.Gartner.com. Rebecca Kush is president of CDISC. Ed Helton is chief scientist, regulatory and biomedical affairs, with SAS and is on the CDISC Board of Directors.

*To whom all correspondence should be addressed.

References

1. C. Rozwell, R. Kush, E. Helton, "CDISC Standards: Enabling Reuse Without Rework," Applied Clinical Trials, June 2006, 76–78.

2. DIA Annual Meeting Presentation: The Business Case for Standards, June 2005, Edward Helton, Carol Rozwell, Stephen Wilson, and Rebecca Kush.

3. DIA Annual Meeting Presentation: Diving Into Details: An Expanded Business Case for CDISC Standards, June 2006, Carol Rozwell, Edward Helton, Stephen Wilson, and Rebecca Kush, Chair.

4. SAS Global Forum Presentation: Standards for Clinical Research from Protocol through Submission: CDISC Business Case and Progress Report, April 2007, Rebecca Kush.