Risk Management in Web Clinical Trials

Eli Hauser, Phase Forward Inc.

Have you thought about risk management in your Web clinical trial? What are the risks? Where are you exposed? Increasingly, senior managers are asking their technology managers to answer these questions as they consider Web technology solutions for clinical trials.

Risk Management Approach
A risk management approach must be comprehensive in both scope and scale. Risks must be categorized and assessed to assure an appropriate and balanced suite of invested responses. Often, risk management is solely focused on managing the schedule to better control the project. This intuitive risk management approach only addresses specific elements of project risk, usually those that the project team has previously encountered. A comprehensive risk management approach spans both operational and project risks.

Risk Management Methods
Risk management is a disciplined approach to systematically identifying threats, assessing consequences, and modifying the environment to adapt to the situation. Threats can range from the unseen to recently emergent problems to a complete redefinition of the current status.

Operational concerns during a clinical trial arise in areas around system availability and incursion, database integrity and recovery, and network security, as well as disaster recovery contingencies. Thus, the first deliverable of a risk management program is an analysis of risk elements to monitor. These risks must then be assessed, both quantitatively and qualitatively, for likelihood of occurrence and magnitude of injury.

With the threats identified, categorized, and ranked, the project team should identify, cost, and select alternative risk management methods and procedures.

Operational Risk
Operational risk addresses the organization's internal needs around the application, the staff, and the system, and cluster into three areas:

• Security Risk: Can we control access? Solution: Investigate system access, data integrity, physical and network access, and password control.
  
• Recovery Risk: Can we continue operations through a disaster? Solution: CPU or disk failure, data corruption, environmental failure.
  
• Procedural Risk: Can we continue to operate if someone is unavailable? Solution: Account for employee turnover, delegation of authority, best practices, and vendor quality.

Project Risk
Web-based clinical trial efforts are systems integration projects, of differing scale and scopes, utilizing myriad people skills, process changes and technology innovations. Planning, communicating, user participation, and training are key elements of project success. Other aspects of risk management include vendor management, software reliability and job design.

Project risk elements cluster into:

• Business Risk: Is this the right solution? Investigate: User benefit? Will the efficiencies emerge? Can we measure the difference? ROI?
  
• Technology Risk: Can we execute? Will the technology work? Investigate vendor competency, software stability, project delivery, and technology compatibility.
  
• Adoption Risk: Can we internalize? Consider: New skills training, transfer and proficiency; new operational requirements; system management tools; and data migration and conversion success are all in play.

Summary
A Web-based clinical trial has a large number of initiatives to manage. Questions to consider include: Are we building the right system? Can our people learn the new skills required? Will the software, hardware, network, and vendors perform as promised? Will the business needs change during the project? Do I need external counsel and expertise? Can the vendor help?

An explicit systematic framework to identify, rate, and rank potential threats to project success and operational quality can guide appropriate choices for prioritizing project issues, directing management attention, and highlighting resource and training investment needs.

Phase Forward
Privately held Phase Forward specializes in drug development automation through Web-based clinical trials of new drugs and devices. Phase Forward's InForm uses Internet technologies to conduct and manage clinical trials efficiently and effectively. Our software and service solutions allow sponsors of clinical trials to eliminate the need to transcribe and process traditional paper data forms, to access global clinical trial data in real-time, and to begin data analysis almost immediately after the last patient has visited the clinic.

About the Author
Eli Hauser is director of technical operations at Phase Forward. Before joining Phase Forward, he was director of corporate applications at Viewlogic Systems, responsible for North American technical support and product quality assurance operations. Before joining Viewlogic, Hauser worked at Symmetrix, a management consulting firm based in Lexington, MA, and at Computervision Corp., a global provider of CAD/CAM software, now part of PTC. Hauser earned a B.S. in electrical engineering from Columbia University, an M.A. in history and M.S. in electrical engineering from Northeastern University, and completed the M.B.A. degree at New York University.

For more information: Karen Wills, Director of Marketing, Phase Forward Inc., 610 Lincoln St., Waltham, MA 02451-2173. Tel: 781-522-3350. Fax: 781-890-4848.