On June 20, 2013, CDISC (Clinical Data Interchange Standards Consortium) announced plans to implement CDISC SHARE (Shared Health And Research Electronic Library), “a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format.” CDISC and BioPharma, Inc., will create a glossary of industry-wide data tags and templates for standardizing medical metadata.
Greater attention to database organization saves time by improving communication. According to this report by Rebecca D. Kush, “standards can help reduce the startup time of a clinical study by 70% to 90% when used upfront in designing case forms and developing the protocol.” When every document is in the same “language,” it is easy to refer back to other documents and collaborate with others. Within the current system (or lack thereof), there can be more than 600 tags for one word. With the implementation of SHARE, every tag has a one-to-one relationship with its meaning across the whole healthcare industry.
SHARE will also standardize the structure of data, making procedures easier to map out and interpret. As you know, your research isn’t operating in a vacuum, so a clearer picture of how data relates to other data is invaluable. Accidental discoveries and unplanned analyses can lead to innovation, so it is important that any information is complete and legible. Ideally, under SHARE, any researcher can understand any raw data, improving the possibility of discovering new insights just by making the information more readable.
The initiative was triggered in part by the FDASIA (Food and Drug Administration Safety and Innovation Act) of 2012. Under FDASIA is the PDUFA (Prescription Drug User Fee Act), which entails that pharmaceutical companies pay fees to the FDA so that the FDA can “maintain a predictable and efficient review process for human drug and biologic products.” With CDISC SHARE in place, regulators like the FDA will be able to analyze data from clinical trials and other medical records more quickly and thoroughly, rmanaging risks more effectively and keeping consumers safe.
According to this white paper, the initiative will also help parties like CROs (Contract Research Organizations), vendors, pharmaceutical companies, and, most importantly, patients. The CROs will be able to avoid wasting time conforming to each client’s standards, as there will be industry guidelines to follow. Vendors can build a successful infrastructure around these new standards. Patients can benefit indirectly because it will become easier for doctors and researchers to access data in crucial moments. Plus, pharmaceutical companies are expected to innovate more quickly, providing cutting-edge treatments to those in need.
The direct benefits of CDISC SHARE to pharmaceutical companies are that they can:
Pull up data on a molecule, treatment, or patient in an instant
Understand fully how a piece of data relates to other data in a system
Easily share data with other organizations to promote collaboration
Prevent unnecessary repetition of tests
Standardize the recording of clinical trial results, making irregularities and errors easier to spot
Improve communication with the FDA, possibly shortening the Research & Development timeline
A possible next step would be for the government to mandate the publishing of raw data in clinical trials and medical research. This regulation would give CDISC SHARE users the ability to build off of each other’s research. Adam Jacobs, PhD, describes the pros and cons of publishing raw data in his guest blog post on PharmaPhorum.
While the benefits of SHARE are obvious, the power of the system will become clearer once more entities adopt it. According to CDISC, who is planning to fully implement the standards across all therapeutic areas by 2017, “the benefits of CDISC standards can only be realized when more and more organizations are using standards consistently and effectively, delivering on the promise offered by SHARE.”