What Lies Ahead for Clinical Data Management?



Pharma IQ
07/07/2010

The storage and management of clinical data has always been and will continue to be a key issue for the pharmaceutical industry.

Collecting, storing and curating the vast quantities of scientific data in existence is not just important for regulatory submissions, but is also vital for ongoing pharma research and clinical trials.

Carole L Palmer, a professor of library and information science at the University of Illinois, believes that "serious commitment and investment" is required by institutions to ensure that clinical and scientific data is stored in a way which makes it suitable for later use.

"Most organisations have serious problems with clinical data management because it's expensive to do systematic curation, which includes documenting the context in which data were generated or derived, including the instruments involved, the protocols and such," Palmer explained.

"It's about doing good science, and ensuring the science is reproducible, but it's also about finding ways to bring data together from different sources and using them in new ways."



Clinical data storage in 2010

At the beginning of 2010, the Clinical Data Interchange Standards Consortium (CDISC) announced the series of strategies which it hopes to focus on in the coming year.

A number of "key drivers" were outlined in the plans. CDISC is encouraging pharma research firms to ensure that they build the correct data collection and storage systems into their projects from the start, by incorporating the concept into the initial planning stage.

The organisation is encouraging firms to take up a wider range of CDISC standards than the submission data standards which have been widely adopted.

"It seems sensible to collect standards the way we want to submit them, thus avoiding costly, time-consuming (and sometimes difficult mapping exercises) to do data conversions at the end of the process, prior to submission, when companies should be focusing on the science of their research," the CDISC explained.

The organisation added that it will continue to drive the adoption of better clinical data standards through the use of the Clinical Data Acquisition Standards Harmonization programme "forcase report forms, as a path to reporting and submission."

The future for pharma research clinical data storage

As with many areas of the pharma research process, the future for clinical data storage could lie within the internet and new technology.

CDISC outlined in its plans for 2010,that it was looking to promote the use of its SHARE initiative, an electronic platform which can be accessed globally.

The project is organised into four sections - method, results, answers to primary questions, other lessons learned and conclusions - and will create standardised data element definitions which can be accessed across a number of applications.

It claims that this will both encourage greater reuse and aggregation of pharma research, as well as reducing costs and providing more consistent data standards, and should implemented in January 2011.

Further to this, CDISC will be attempting to integrate clinical data within Electronic Health Records and Health Information Technology, which it claims is where the future of clinical data capture is leading.

CDISC sees the benefits of this as being an improved ability to recruit sponsors into trials, easier accessibility to the data for research, a streamlined data capture process, improved pharmacovigilance and a decrease in the number of systems required at individual sites.

However, not everyone advocates the use of digital data for pharma research projects.

Carole L Palmer, a professor of library and information science at the University of Illinois, said that research libraries still play an integral role in the storage of clinical data.

"Digital content, including digital data, is much more vulnerable than the print or analogue formats we had before," Palmer explained.

"The common perception is that keeping information online keeps it alive, but someone, somewhere, has to maintain it, making it accessible and usable for researchers."