Improving Clinical Data Management Through CDISC Standardisation



Pharma IQ
03/23/2011

Clinical trials are taking place on an increasingly global scale and are under rising pressure as companies look for the fastest and most cost effective way to get their product to market. Data standardisation is one way through which firms can help achieve these aims.

When the European Medicines Agency announced its guidelines for the handling of electronic data within clinical trials last year, it based these on the 12 principles laid out in the Clinical Data Interchange Standards Consortium (CDISC) , Standards and Electronic Source Data within Clinical Trials document.

The importance of data standardisation

The benefits of CDISC go beyond efficiency gains. At a time when collaboration between governments, research organisations and the pharmaceutical industry is increasingly being sought to deal with medical threats, such as cancer, data standardisation is also an important factor in improving public health.

The United States Food and Drug Administration (FDA) signed a deal in December 2010 to transform legacy data into a standard electronic format.

Working with CDISC, ScenPro and Octagon Research Solutions will convert clinical trial data to a standardised format, harmonising variable terminology, in an effort to facilitate the answering of both scientific and regulatory queries.

David Evans, chief information officer at Octagon, said: "This project is illustrative of the industry's trend toward data standardisation to promote analysis and evaluation of therapies across therapeutic classes to promote public health."

The Critical Path Institute and CDISC also recently entered a collaboration to create new clinical data standards to help the pharmaceutical industry better develop new therapies for major diseases.

A previous partnership between the pair led to the creation of the Alzheimer's disease clinical database and they are to now work in databases for those which the FDA recognises as posing a serious public health risk, including brain diseases, lung cancer and diabetes mellitus.

Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research, said: "Companies are struggling to develop new therapies to treat a variety of diseases and conditions. The lack of clinical data standards and accurate databases that truly describe the progression of diseases is a major impediment to making rapid progress."

Implementing CDISC standardisation strategies

Working with CDISC standardisation is valuable throughout the drug development process, but of late the organisation has been focusing on the benefits of implementing standards at the "front end" of the clinical research process.

Under the slogan Using Standards From The Start, CDISC has been encouraging firms to account for standardisation during the initial design phase of the clinical trial.

It explained many companies were focussing on the adoption of submissions data standards, but the greatest benefits of harmonisation – namely time and cost savings and higher quality data – can be seen if standards are adopted early.

"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," AJ de Montjoie from CDISC Communications said.

One of its key aims for 2010 was to further adoption of these front-end standards.

CDISC was also keen to further its collaboration and reach on a global basis. Standards were recently translated into Japanese, while the CDISC China Advisory Council Charter was signed, which is intended to boost clinical research standards in the country.

As clinical trials increasingly move out of established markets to emerging locations like those mentioned in Asia, this is one mission which is only likely to increase in importance.

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