Clinical trial data and the challenge of setting standards from the start

Streamlining formats for clinical trial data collection and harmonisation across system platforms was the focus at CDISC International Interchange last November.

The Clinical Data Interchange Standards Consortium (CDISC), a non-profit standards developing organization, hosted its International Interchange meeting in Chicago, US, in mid-November last year. The meeting was held at Fairmont Millennium Park and around 500 participants from all over the world attended – among them Uppsala Monitoring Centre’s technology evangelist Magnus Wallberg and software developer Mikael Nilsson.

CDISC is an organization devoted to standards and harmonisation in clinical research. The CDISC standard is for clinical trial data and submissions what the E2B standard is for pharmacovigilance. The organisation’s pursuit for harmonisation and data sharing in clinical trials very much resembles what UMC strives for in pharmacovigilance.

In her opening remarks, CDISC’s Founder and President Rebecca Kush said, "When clinical data speaks the same language, research delivers. When data talks, a world of cures can be unlocked".

CDISC campaign site, www.unlockcures.org, goes further into explaining that a problem with clinical trial data is that it’s “either not shared, or shared in ways that do not support learning.” The website continues, “Because many times the data is collected in a hodge podge of formats that won't allow it to talk. This practice of ‘siloed research’ is a disease in itself, leading to redundancies and dead ends, and the loss of valuable time and billions of dollars. Most tragically, when data doesn't talk, we lose our patients.“

A very big topic during the conference was the integration between EHR systems and the CDISC standards. This integration is crucial in order to streamline the collection of clinical trial data and avoid double data entries, and thereby minimize both the workload and the risk of human errors. Standards from the start was the leading message at the conference.

Another major topic was SHARE, a web based system provided by CDISC, which delivers all the standard terminologies and meta data defined by the CDISC standard. SHARE can theoretically be directly integrated in data collection tools to guarantee conformance to the CDISC standard.

The WHODrug is very commonly used as the dictionary to code and transfer information about concomitant medications in clinical trials. Thus, it is very important for UMC to be represented at CDISC conferences to support WHODrug users and share information about new tools, services and dictionary enhancements. Since WHODrug is nowadays also the recommended drug dictionary by authorities like the FDA and the PMDA, it is even more important to be present at such events.

Aside from presentations and plenaries, there was also much room for networking during the conference’s well-extended lunch and coffee breaks. UMC had a booth to which existing and new WHODrug users could turn for information, and its representatives also took the opportunity to visit other booths to make new contacts and exchange knowledge.