Ed Helton

Conducting clinical research rapidly and cost effectively is the dream of every biopharmaceutical company. But there's more to it than just ensuring activities are completed in a timely manner and without additional expense, or even that a drug spends the maximum time on the market once it is approved. Biopharmaceutical companies want to make sure that their treatments are safe and efficacious, and that risks to the intended patient population are kept to a minimum. An essential ingredient for improving the clinical trials process is an information management approach based on industry standards. 

Standards support industry best practices 

Currently, many clinical development programs are plagued by data quality problems, duplicate data entry, and excessive transformations from one format to another that steal time and introduce errors. Interest in using industry standards for the collection, organization, and submission of clinical trials data is certainly growing, but is not yet ubiquitous. Based upon work in other industries, Gartner reported that automating processes and using data interchange standards can produce significant benefits in process efficiencies and could save the biopharma industry between $5.8 and $6.6 billion dollars per annum (this number was calculated using the industry's 2004 spending on R&D and Gartner's average of the percent of R&D costs attributable to clinical trials).

Nonetheless, a robust and defendable business case is required so that biopharmas can make decisions on the optimal process stage and implement data interchange standards in the context of clinical development.   

With that goal in mind, CDISC, working with the support of Pharmaceutical Research and Manufacturers of America (PhRMA) and Gartner, undertook a research project to: 					

collect information on current environments and processes that influence standards implementation and adoption

identify benefits that may not immediately translate into cost savings

assess the impact of implementation on the development process.

Through a series of interviews with biopharmaceutical company representatives and service providers, a baseline of information for current processes, personnel, time, and cost required to conduct clinical trials and other processes within the clinical development continuum was collected. Following the interviews, an online survey was conducted to capture additional metrics. In this article, we present an initial high-level summary of the findings thus far. The complete results will be reported in future communications.    

The interviewees were familiar with the CDISC standards and how they enhance the end-to-end data flow across the clinical research process (Figure 1). By utilizing the CDISC Operational Data Model (ODM) as a transport standard, data about the protocol and study data collected on subjects can flow seamlessly through the entire clinical trial process—from source to analysis/reporting to regulatory submission and electronic data archive. The data content and metadata are structured using the Study Data Tabulation Model (SDTM), which can be transported via the ODM.  

 Figure 1. End-to-end data flow across the entire clinical research process.			

Common issues expressed as problems in a process without standards relate to the disruption in the data flow shown in Figure 1. Many sponsors expressed the belief that standards could provide a significant improvement in their clinical development process. They pointed to a reduction in the time required to: 					

create case report forms and the database

lock the database after last subject visit

program a table or develop an SAS program 

Many sponsors indicated that standards also offer some difficult to quantify benefits, such as the ability to: 					

devote more time to the science behind the trial, not just the data

enable better communication among the various teams involved in the clinical trials process, including as data management, clinical operations, and statistics 

reconcile and report on adverse events across a series of clinical trials

eliminate data transformations and rework

cull out unnecessary work and improve trial design

ensure consistency from one step in the process to another

minimize redundant data sets and data flows 

reduce the chances of errors and inconsistencies

permit the population of a data warehouse across trials/programs.

Contract research organizations (CROs) spoke of similar issues, as well as the problem of dealing with multiple sponsors who all have their own ways of doing things. They cited problems such as: 					

multiple formats for case report forms and databases

multiple vocabularies that must be reconciled

CROs thought that standards would help them alleviate many of these problems. They cite significant decreases in set-up time for trials if they can use standards from case report form design through the reporting stage of the trials. 

What's next for business case development?

The next steps in the business case project are to review in depth the information gleaned during the interviews and combine it with the information gathered through the online survey. Typical scenarios can then be developed so biopharmas can select a standards implementation path that will best meet their situation. The best practices will also be detailed. 

One of the challenges mentioned by many of the biopharmas during the interviews was the concern that the standards were not stable or that they would change frequently, thus requiring constant upgrades. 

To address this concern, CDISC is committed to maintaining the production standards and to making any enhanced versions backwardly compatible. They are also documenting how the standards work together. The technical roadmap for CDISC includes the development of one common, harmonized standard that will ensure ease and consistency across the full life-cycle of a clinical trial. Hence, efforts are underway to align the various CDISC models throughout the data flow process. This year, CDISC reorganized from seven standards-development teams into three focus areas:  

				   1) maintaining the production standards; 			

				2) providing implementation support and services; and 			

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Ed Helton

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