Digital Credentials Ease Clinical Trials

Digital Signatures, Cloud Computing Cut Paperwork Howard Anderson (ismg_editor) • April 18, 2011

Participants in an authentication pilot project claim they've demonstrated that using interoperable digital identities, digital signatures and cloud computing has the potential to accelerate the initiation of clinical trials of new drugs and treatments while lowering costs.

The first phase of the pilot involved researchers at the National Cancer Institute's Cancer Therapy Evaluation Program, the world's largest sponsor of cancer treatment clinical trials, and Bristol-Myers Squibb Co. Phase two, now under way, also includes another drug company, sanofi-aventis.

The researchers used interoperable digital identity credentials. The software installed on a computer, cell phone or other device establishes a close link with the user's proven identity and allows for the application of digital signatures to electronic documents, according to a whitepaper on the project. Digital signatures cryptographically guarantee the integrity of documents to which they are affixed.

Role of Cloud Computing

Researchers say the study showed that certain paper-based processes now used to initiate clinical trials can be eliminated using the new technologies. In the pilot, electronic documents were placed in the cloud, where researchers were able to access and sign them. Previously, a paper-based process required use of a courier service, fax or other time-consuming methods of obtaining a signature.

The digital credentials the researchers used exist within legally binding and regulatory-compliant cyber-communities, known as identity trust hubs. All federal agencies use the Federal Bridge identity trust hub. The biopharmaceutical and healthcare industries use the SAFE-Bio-Pharma identity trust hub. These two hubs were cross-certified to make them interoperable, enabling a digital identity asserted by one to be trusted by the other.

In related news, the Obama administration on April 15 unveiled a federal government/private-sector strategy that it says would eventually let users obtain a single credential as a one-time digital password in the form of software on a mobile device, a smart card or token to transact business over the Internet. (See: Single Digital Password Credential Sought). See also a related blog on trusted identity.