Making Sense of CDISC: Mandatory Requirements and Clinical Trial Processes

CDISC (Clinical Data Interchange Standards Consortium) standards will very soon be mandatory for companies submitting new drug applications in the United States and Japan. The move by the Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will soon be followed by the European Medicines Agency (EMA), and companies must ensure they are ready.

Srinivasa Rao Mandava, CDISC Expert, CSC

The purpose of the standards is to streamline medical research, including the protocol preparation for a clinical trial, the design of the annotated case report form (CRFs), clinical data sets with corresponding metadata, the data definition file, and beyond. CDISC will have a huge impact on legacy data in terms of standardizing the information in CRFs and the design of the CRF.

Regulators want clear information not only about the study protocol and design, but also on the actual outcomes. In other words, to what extent was the study design followed, and how and where did it deviate. That includes patients making unscheduled visits, as well as the collection of unscheduled lab and other domain data. They also want harmonization of terminology to remove confusion for reviewers, sponsors and investigators.

The benefits to standardization are clear: Better representation of the clinical data, greater clarity during the review process, and data consistency allow the data to be re-used. Standardization has another significant benefit for the life sciences industry: By reducing the time to enrol patients and gather data, it greatly improves the time and resource savings in the drug development process. In fact, a report from CDISC estimates that sponsors can save 70% to 90% of time and resources in study start-up through standardization. The reason for this is that when the CRF is streamlined and standardized, it’s easier for patients and investigators to understand and fill in.

A further benefit is that sponsors will face fewer questions from reviewers about the data if it is gathered in a standardized format.

What’s the Hold Up?

The question one might ask is, given the advantages, why weren’t life sciences companies across the board quick to embrace CDISC standards? Many large companies are in advanced stages of CDISC adoption and either are deploying the standards process in-house or are outsourcing data standardization.

Scientists working in labOther companies have just started thinking about adopting clinical standards, in part because it will be mandatory by the end of the year, but also because they have faced, and continue to face, problems with getting their data approved due to inconsistencies and lack of proper explanation of collected information in terms of investigational drug safety and efficacy. The challenge for smaller, tier 3 companies is that they lack the resources – in terms of in-house expertise, the number of people to manage the process, the methods and the tools and technology required.

Already, companies outsource the management of their clinical trials to clinical trial organizations. Outsourcing the standardization of clinical data is really just the next step in the process. Instead of bringing raw data in-house and conducting standardization themselves, by outsourcing that part of the process, life sciences companies further streamline the preparation of their regulatory submission.

The alternative is to create in-house CDISC standardization capabilities, which will require companies to put in place the technology expertise, the regulatory expertise, the tools and the standardized processes.

As the industry moves ever closer to mandatory CDISC standardization, they must ensure they are ready to meet the requirements without detracting from their major objective: developing and delivering effective products for global markets.

Join CSC’s live webinar, CDISC Clinical Data Standardization, on June 28 to learn more.

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