EXPERT COMMENTARY
By Rodd Schlerf
Life Sciences Manager, ARX
Oct. 27, 2008 | Sponsors are continuously searching for operational improvements that hasten the setup, initiation, execution, and closeout of clinical trials to more quickly capture important data that substantiates a new product’s safety, efficacy, and performance compared to currently marketed products.
The speed of clinical trial execution correlates directly with increases in market share, margins, and revenues.
It is commonly estimated that more than 90 percent of a drug’s profit margin is lost over the first 12 months after it goes generic. The sooner a new drug reaches the market before an alternate remedy does, the better the chance of capturing market share and maximizing the tight window of exclusivity from day of launch.
Therefore, sponsors are adding resources and spending substantial amounts of money to pinch days and weeks from every clinical activity. While this has resulted in some modest increases in study performance, it has also been a significant factor in the escalating cost of developing and bringing new biopharma product to market. The Tufts Center for the Study of Drug Development placed this cost at $802 million in 2001, and $1.2 billion in 2006 – a huge increase from the estimated $231 million just 15 years ago.
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| Rodd Schlerf |
In the past several years, numerous automation and outsourcing strategies have helped improve clinical trial performance. However, there is one constant that continues to limit these benefits: paper.
Paper is still the most prevalent format for clinical records, but that is rapidly changing. Innovations in digital signature technology in the last five years, coupled with cost reductions of as much as 90 percent, have made paperless clinical trial execution the preferred method of managing clinical records. Adopting today’s digital signature technology represents one of the most substantial opportunities for sponsors and clinical research organization (CROs) to streamline clinical trials.
Three applications in which public key infrastructure (PKI) standards-based digital signatures provide trusted paperless electronic records and, as a consequence, significant savings in cost and time, include:
1. Field/Site Operations – clinical site monitoring and documentation requiring approval (signatures) by clinical research associates, project managers, investigators, and coordinators.
2. Audits and Compliance – Standard operating procedures (SOPs), work instructions and project- or activity-specific documentation required to support potential audits, and which can be used as evidence to show compliance with established procedures.
3. Secure Document Exchange and eSubmissions – regulatory, clinical, and business documentation that needs to be trusted across organizational boundaries in a collaborative clinical ecosystem, including electronic submissions to the FDA.
Digital Signatures in Field/Site Operations
Digital signatures enable organizations with geographically dispersed employees to sign and approve documents without relying on printed paper and priority mailing.
CROs and sponsors benefit from digitally signing site-generated documentation, such as monitoring trip reports, where speed is essential (usually required under the contract to be submitted within 10 days of the site visit). Several of the largest CROs estimate that digital signatures for this single application can reduce or eliminate more than $500,000 in annual priority mailer costs alone.
The clinical sites have also picked up on this value. Digital signature technology is now cost-effective and simple enough that individual sites or networks can affordably deploy digital signatures or acquire them from a service provider.
Digital Signatures for Audits and Compliance
Digital signatures are making a dramatic impact on the way organizations create and manage controlled documents that may be called into evidence to support an audit.
Since the release of the first FDA 21CFR Part 11 guidance in 1997, many companies have created electronic source documents through the use of electronic document management (EDM) systems. This flawed approach creates electronic records that are proprietary and tied exclusively to the database and repository of the EDM vendor.
As workflows and approvals span across organizations, the only way to create sustainable electronic source documents is with digital signatures.
With today’s digital signatures (stand-alone or integrated with an EDM), electronic source documents are trustworthy and can be exchanged with external auditors and parties that need access to these records, entirely independent of the vendor and organization that created them.
Global organizations can immediately access secure documents created throughout the enterprise from any authorized computer to support an auditor’s request. Further, external parties can verify electronic records (signer’s ID, intent, and document integrity) without any proprietary software or system access for the full retention period of the records.
Digital Signatures for Secure Document Exchange and eSubmissions
Audit and compliance documents are not the only applications for digital signatures that need to be accessed and trusted beyond the walls of the organization.
A good example is organizations that are hosting application services such as shared clinical trial management system (CTMS) service for collaborative clinical ecosystems. Huge networks spanning hundreds and thousands of organizations including investigators, institutional review boards, CROs and sponsors participating in these clinical exchanges and portals can access and sign regulatory packets and other ongoing study documentation.
The digitally signed records created in a secure document exchange are portable and sustainable over time and across organizational boundaries.
Both PDF (ISO standard 19005-1 PDF/A archive) and PKI digital signatures (standards governed by U.S. and E.U. governments, and independent bodies) are standards based. Hence, digitally signed electronic records can be retained and verified for decades. Organizations can have complete confidence that the documents will be both human-readable and verifiable, even if the vendor or organization that created the digitally signed PDFs is no longer in business.
These are just three examples of how PKI standards-based digital signatures are being used today in thousands of validated good clinical practice applications. Only these digital signatures have trust, sustainability and verifiability both inside the organization and externally throughout a clinical network, including regulatory authorities. PKI-based digital signatures not only provide paperless approvals and source electronic records much faster, but also result in quantifiable cost saving resulting from reduced clinical trial duration, increased operational efficiency, faster submissions, and quicker approvals.
Rodd Schlerf is life sciences manager for ARX (Algorithmic Research) North America, 855 Folsom Street, Suite 939, San Francisco, CA 94107, (410) 464-0351, email: rschlerf@arx.com
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This story first appeared in eCliniqua,one of Bio-IT World’s free e-newsletters. Subscribe here.