Many pharmaceutical and biotechology companies use CDISC standards when creating databases for new clinical studies. The FDA has recently stated that it “will develop guidance for the industry on the use of CDISC data standards for the electronic submission of study data in applications”.
Adopting and implementing CDISC standards can increase drug development analysis costs. However, identifying the right process for implementation and choosing the appropriate technology can reduce the costs of adopting these standards, making it a very worthwhile investment. ARITHMOS looks at some technology considerations.
Automating Tools to Ensure Consistency
Establishing the correct workflow to manage this CDISC implementation process is the first key step. Sponsors should look at automation tools to create standard data sets to ensure speed and consistency. There are commonly available software applications – for example, SAS can be used to convert Excel data sets and apply metadata attributes to the CDISC domains.
Data Repositories for Information Management and Cost Reduction
Implementing CDISC standards means adopting technologies that can manage the flow of data and information. Keeping clinical data in multiple repositories can create a complex management process and is often prone to error. Managing multiple repositories can mean spending more time on vendor management.
Setting up a central database for all data – whether from a laboratory, a CRF or an ePRO device – to be stored in one place, allows for an easier mapping process. With a centralized hosting system, the process is linear and traceability is under control. A centralized system also provides easy data transfer to the Sponsor, Regulatory Authority or Purchaser.
Benefits to Hosted and Centralized Storage:
- Cost: Avoid paying multiple CROs or technology providers to set up a global library, program macros and perform validation checks
- Efficiency and Time: When the team is already familiar with Sponsor requirements the review cycle reduces. Training and HelpDesk costs also reduce.
- Quality: Measurement scales, design features, outputs and summaries all become standardized.
- Access to Data: Reporting and access to data becomes much more straightforward. Central web access can be used by sponsors to obtain important safety information, efficacy data and study progress reports.
- Information in a single point of storage/database
- One audit trail data source
- Same location for study data and derived data
- Traceability is possible from beginning to product submission and market authorization
- One portal for real-time reports
- Reporting availability on devices: laptops, tablets, smartphones, etc.
Clinical Data Visualization and Business Intelligence analytics can support CDISC mapping projects if data is spread across multiple databases and sources. These tools can collect the data from multiple or disparate databases and display the data in a structured format.
The customization of data visualization tools means that clinical trial leaders can see specific metrics that matter to their study as well as see data in real time and “on the go”.