Cloud computing, digital signatures speed clinical trials

By Mike Miliard
10:46 AM
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A new whitepaper has demonstrated that the use of interoperable digital identities, digital signatures and cloud computing helps accelerate the initiation of a clinical trial while lowering costs.

A new whitepaper has demonstrated that the use of interoperable digital identities, digital signatures and cloud computing helps accelerate the initiation of a clinical trial while lowering costs.

The study, titled Research Collaboration in the Cloud: How NCI and Research Partners are using Interoperable Digital Identities, Digital Signatures and Cloud Computing to Accelerate Drug Development, shows the results of a 2010 pilot program in which researchers at the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI/CTEP), the world’s largest sponsor of cancer clinical treatment trials, and Bristol-Myers Squibb used cloud-based IT to eliminate reliance on paper forms in clinical trials.

[See also: 5 areas that will see cloud computing ROI.]

Researchers were each given interoperable digital identity credentials – software installed on a computer, smartphone or other device, that establishes a close link with the user’s proven identity and allows for the application of legally binding, digital signatures to electronic documents.

Digital signatures guarantee the integrity of documents – such as protocol receipt acknowledgement letters, protocol approval/disapproval forms, clinical trial agreements and contracts – by protecting every bit of information from being changed.

In the pilot, the electronic documents were stored in a secure cloud-based environment where the researchers were able to access and sign them immediately. Prior to the study, the process was delayed by the necessity of sending physical documents through courier service or fax for signature.

Substantial cost savings are anticipated as the pilot moves to production, according to the whitepaper.

  • Using paper forms, an average 10 percent of clinical documents are shipped overnight and 10 percent are shipped by courier service. Using digital signing, those costs are eliminated.
  • The time savings are significant, as well: In paper-based research, typically it takes three to five business days per signature. The pilot demonstrated that each digital signature can take minutes. Furthermore, "NCI/CTEP estimates that in 2010 documents comprising almost 100,000 pages were used to develop and correspond on its clinical trials," according to the study. "While the unit does not track the time involved in scanning, organizing and sending these paper documents to the FDA, it reports that it is extremely labor intensive and, once digitized, will be greatly simplified."
  • The pilot study also eliminated the problem of lost or misplaced documents. Using digital signatures establishes an audit trail of when the document was uploaded, of the email sent to alert the signatory that the document is available for signature, and when the document was actually signed.

Ultimately, the pilot project shows that "combining interoperable digital identities, digital signatures and cloud computing in clinical trials may (improve) delivery of medicines to patients, while meeting a variety of privacy, security and environmental goals."

[See also: Study: Clinical trial privacy safeguards lacking.]

Phase II of the study, which is under way, expands to include researchers with sanofi-aventis. Phase III, which is expected to start mid-year, will include researchers at universities and academic cancer research centers. Their digital identities are a part of the Research Education Bridge Certification Authority (REBCA), an identity trust hub serving the country’s higher education sector and which currently is in the process of cross-certifying with other trusted cybercommunities.

The results of the pilot will be touted on Friday as officials with the Obama administration announce the new National Strategy for Trusted Identities in Cyberspace (NSTIC), a White House initiative to improve online security, increase privacy and foster economic growth and innovation online.


Read the whitepaper here.