Study: Paperless clinical trials offer advantages

There's been progress in an effort to show that paperless clinical trials can save time and money compared with traditional trials that involve hard copies of documents.

A new white paper released on April 15 showed that digital identities, digital signatures and cloud storage of electronic documents could accelerate the start of clinical trials and reduce costs. The paper covered a 2010 pilot study that included researchers from the National Cancer Institute and the drug maker Bristol-Myers Squibb ($BMY). The researchers were given interoperable digital identity credentials, which is software that enabled them to put their authenticated digital signature on electronic documents. The electronic documents were kept in cloud-based storage, which enabled the researchers to quickly and securely retrieve them.

This ongoing study is important because there's a great need to find ways to expedite clinical trials and reduce the cost of the studies, which are notoriously expensive and time-consuming in their current form. Though electronic data capture and other technologies have helped simplify information transfer and storage in clinical trials, there are still many instances in clinical trials where pen and paper are the status quo. In fact, the NCI estimated that its clinical studies required 100,000 pages of documents in 2010 and an untold number of hours to fax or mail the documents to the FDA.

Yet there's apparently a need to make sure that further digitization of clinical trials can be done without sacrificing the integrity of the documents involved in the clinical investigations. Phase II of the study is underway and involves researchers from the French drug giant Sanofi-Aventis ($SNY). By mid-year, plans call for the study to advance to Phase III and include researchers from universities and academic cancer research centers. We'll see whether this effort leads to significant changes in the way certain information is documented and stored in clinical trials.

- get the white paper here
- here's the release

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