Digital Credentials Ease Clinical Trials

Digital Signatures, Cloud Computing Cut Paperwork
Digital Credentials Ease Clinical Trials
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.

About the Author

Howard Anderson

Howard Anderson

News Editor, ISMG

Howard J. Anderson is news editor of Information Security Media Group and was founding editor of HealthcareInfoSecurity and DataBreachToday. He has more than 34 years of journalism experience, with a focus on healthcare information technology issues. Before launching HealthcareInfoSecurity, he served as founding editor of Health Data Management magazine, where he worked for 17 years, and he served in leadership roles at several other healthcare magazines and newspapers.

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