BOX 2-3

Using Digital Technologies to Enhance Data Integrity

Digital technologies can pose risks to data integrity, but they also offer ways to improve the reliability of research data. By enabling phenomena and objects to be described and analyzed more comprehensively, they make it possible to remove some of the simplifying assumptions inherent in earlier research. They enable researchers to build checking and verification procedures into research protocols in ways that reduce the potential for error and bias. Automated data collection that is quality controlled can be much more accurate when either substituting for or supplementing human observations.

Although examples from many disciplines could be cited, a good example is the use of digital technologies in clinical research, including the conduct of clinical trials and plans to link clinical trial information with individuals’ electronic health records.

Access to the data behind the production of new drugs and other medical treatments is often a contentious issue because of the proprietary traditions of the pharmaceutical industry and concerns about the privacy and security of patients enrolled in clinical trials. Nonetheless, the trend in drug development is toward openness, as databases are made more widely available and prepublication information is published in electronic form to make significant findings quickly available. For example, a GlaxoSmithKline Clinical Trial Register has been created to afford online access to factual summaries of clinical trails of marketed prescription medicines and vaccines.a Although some specialty journals oppose this practice, the general trend toward openness is being pulled by powerful demands for public assurances about accuracy, completeness, and timeliness.

In the United States the federal government has been the primary force behind making drug development data both electronic and public. The Food and Drug Administration (FDA), for example, is moving away from onsite audits of clinical trials to statistically based sampling and electronic audits. The agency is adapting many tools borrowed from the banking, nuclear, and other sectors where security checks and balances have been in place for a long time.

An important catalyst for electronic data handling has been the FDA’s issuance of regulation 21 CFR Part 11 in 1997,b which provided criteria for acceptance of electronic records and electronic signatures. This regulation not only opened the door to electronic submissions but also encouraged the widest possible use of electronic technology in all FDA program areas, including data storage, archiving, monitoring, auditing, and review. A significant goal was that data should be shareable between sponsors and reviewers.

In 2004, FDA made electronic submission mandatory and called for electronic data handling as well, with the primary goal of faster product reviews and acceptance. FDA is currently planning to adopt single standards for the full life cycle of clinical trials, from the protocol through the capture of source data to analysis, submission, and archiving.

Industry has long been viewed as opposed to making data supporting clinical trials or publications public, partly out of a desire to maintain competitive advantages and partly out of concern that data could be misjudged, mishandled, or otherwise abused in a public forum. This attitude is starting to change as the use of the Internet



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