Innovative Paperless Clinical Trial Study to Be Highlighted Tomorrow

Innovative Paperless Clinical Trial Study to Be Highlighted Tomorrow When U.S. Commerce Secretary Gary Locke and Senior White House Officials Unveil Administration's National Strategy for Trusted Identities in Cyberspace

  • Study Shows How Interoperable Digital Identities, Digital Signatures and Cloud Computing Improve Clinical Trial Start-Up Process
  • White Paper Available

FT. LEE, N.J.--(BUSINESS WIRE)--Using interoperable digital identities, digital signatures and cloud computing accelerates initiation of a clinical trial while lowering its costs, a group of government and industry cancer researchers recently found. They participated in the first phase of a pilot study examining the use of interoperable digital identities and cloud-based digital signatures to eliminate reliance on paper forms in clinical trials.

The pilot will be displayed tomorrow, Friday, April 15, when U.S. Commerce Secretary Gary Locke will be joined by Chair of the National Economic Council Gene Sperling and White House Cybersecurity Coordinator Howard A. Schmidt to release the administration's 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.

The ongoing study involves researchers at the National Cancer Institute's Cancer Therapy Evaluation Program (NCI/CTEP) and Bristol-Myers Squibb Company. NCI/CTEP is the world's largest sponsor of cancer clinical treatment trials.

The researchers were provisioned with interoperable digital identity credentials, a form of software installed on a computer, cell phone or other device, which establishes a close link with the user's proven identity and allows for the application of legally binding, digital signatures to electronic documents. Unlike their simple electronic counterparts, digital signatures guarantee the integrity of documents by protecting every bit of information from being changed. In the pilot study, the electronic documents were placed in shared secure digital storage (i.e., cloud computing) 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.

The study demonstrated that with online trusted identities significant time and cost savings can be achieved over the hard copy paper systems currently used for clinical trials. The pilot shows that an outcome of combining interoperable digital identities, digital signatures and cloud computing in clinical trials may be improved delivery of medicines to patients, while meeting a variety of privacy, security and environmental goals.

The digital credentials used in the pilot exist within legally-binding and regulatory-compliant cybercommunities, known as identity trust hubs. All US federal agencies are served by the Federal Bridge identity trust hub, which provided the NCI researchers with their digital identity credentials. The biopharmaceutical and healthcare industries are served by an identity trust hub known as SAFE-BioPharma, through which the Bristol-Myers Squibb researchers received their credentials. The Federal Bridge and SAFE-BioPharma cross-certified to become interoperable, allowing a digital identity asserted by one to be trusted by the other. Both the Federal Bridge and SAFE-BioPharma are part of a matrix of identity trust hubs serving governments, industry sectors and higher education.

Phase II of the pilot study, which is under way, expands the study to include researchers in 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.

NCI/CTEP estimates that in 2010 documents comprising almost 100,000 pages were used to develop and correspond on its clinical trials. 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, greatly simplified.

Details of the study are documented in a newly published white paper, "Research collaboration in the cloud: How NCI and Research Partners are using Digital Identities to Accelerate Drug Development." The white paper can be downloaded, free, at:

About SAFE-BioPharma

SAFE-BioPharma® is the industry standard developed to transition the biopharmaceutical and healthcare communities to paperless environments. It is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents. SAFE-BioPharma is a non-profit which was developed by a consortium of biopharmaceutical and related companies, with participation from the US Food and Drug Administration and the European Medicines Agency.

SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit or follow us on Twitter at