Innovative paperless clinical trial study highlights time and cost savings
Using interoperable digital identities, digital signatures and cloud computing can accelerate the initiation of a clinical trial and also lower costs, report a group of government and industry cancer researchers. They participated in the phase I of a pilot study that used interoperable digital identities and cloud-based digital signatures to eliminate reliance on paper forms in clinical trials.
The ongoing study involves researchers at the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI/CTEP) and Bristol-Myers Squibb. 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--providing a close link with the user’s proven identity and allowing for the application of legally binding, digital signatures to electronic documents. Digital signatures, unlike electronic ones, guarantee the integrity of documents by protecting information from being changed. In the pilot study, the documents were placed in shared secure digital storage (i.e., cloud computing) where the researchers were able to access and sign them immediately. No physical documents, courier service or fax for signature needed.
The digital credentials used in the pilot exist within legally-binding and regulatory-compliant cybercommunities, known as identity trust hubs. All U.S. 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 two are cross-certified to become interoperable, allowing a digital identity asserted by one to be trusted by the other.
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.