The Clinical-Trial Process Improving Clinical-Trial Performance Effectively managing the vast number of dispersed resources involved in conducting a clinical trial requires a cohesive approach that assures clinical study and regulatory knowledge to achieve high quality and timely study results. Donald A. Deieso, Ph.D. President and CEO The challenge for all sponsors of clinical trials is accelerating time to market. Meeting that complex challenge is easily derailed by the inability of employees, contractors, and site personnel to understand and execute their responsibilities without error. Effectively managing the vast number of dispersed resources involved in conducting a clinical trial requires a cohesive approach that assures clinical study and regulatory knowledge in order to achieve high quality and timely study results. A results-oriented approach that minimizes study errors and costly delays in time to market is one way to overcome the challenge. Meeting the Clinical-Trial Challenge Sponsors need a practical global communication and distribution system that extends throughout the clinical-trial process and that delivers objective documentation to confirm that each study resource understands the specific study requirements. Equally important, is the need to create and maintain an automated, centralized repository that confirms the distribution and receipt of study documents, providing a Part 11-compliant e-signature and audit trail. For study participants to understand the nuances of a clinical study, the typical “islands” of information among the sponsor, IRB, investigator site, and clinical research organization need to be transformed into a seamless system that extends from site selection through study initiation, study execution, and completion. By integrating the disparate information silos, sponsors can improve team performance and quality, ensure regulatory compliance, and reduce risk and liability. Assuring Knowledge and Efficiency Throughout a Clinical Trial Sponsors need an efficient means to screen potential sites, whether at the start of a study or as new investigator sites are enrolled. First there should be the ability to distribute the protocol synopsis along with an online application to identify site and subject quality. To promote the cost-effective selection of study sites, sponsors should have the capability to prequalify sites remotely through online assessments. Once prequalified, sponsors may schedule more costly onsite inspections for final enrollment into the study. The archived profiling results of each site also expedite site selection for future studies. According to industry statistics, more than 63% of clinical-trial delays can be attributed to the failure of site investigation teams to understand and follow an established protocol. A study-initiation program should give sponsors an objective assurance that their investigator teams understand the protocol and other mandatory obligations. To optimize the productivity of the investigator meeting, the protocol and an objective assessment should be distributed beforehand. Analysis of the assessments enables the sponsor to identify knowledge gaps and then tailor the investigator meetings to clarify these gaps. With the use of interactive technology during the meeting, additional objective knowledge assessments will assure that critical study requirements are understood. If knowledge gaps remain, sponsors can develop targeted, cost-effective remediation plans that may include prioritized site monitoring visits and online delivery of a role-based clinical-study curriculum. Throughout study execution, an automated document distribution and communication system can ensure timely, consistent, and documented distribution and comprehension of study information. As new sites are enrolled or the study experiences key personnel turnover, study initiation materials and study documents can be easily redistributed for review and assessment. Finally, upon study completion, sponsors retain a validated audit trail of all documents distributed to trial participants. Sponsors can correlate these study data with key performance metrics, such as the number of protocol deviations or violations, to identify the quality and productivity of each site. Sponsors also can leverage archived knowledge assets, such as assessments, for use in later study phases or trials. Managing Islands of Dispersed Study Resources For study participants to understand the nuances of a clinical study, the typical “islands” of information among the sponsor, IRB, investigator site, and CRO need to be transformed into a seamless system that extends from site selection through study initiation, study execution, and completion. By integrating the disparate information silos, sponsors can improve team performance and quality, ensure regulatory compliance, and reduce risk and liability. Multidisciplinary Skills Needed by Investigator Teams More than 63% of clinical-trial delays can be attributed to the failure of site investigation teams to understand and follow an established protocol. A study-initiation program should give sponsors an objective assurance that their investigator teams understand the protocol and other mandatory obligations. EduNeering is a pioneer in technology-supported learning and creates client-specific knowledge solutions that enable organizations to improve their operational performance and assure compliance while minimizing liability. Governmental agencies and private companies in the life-sciences, healthcare, food processing, and industrial sectors rely on EduNeering to drive employee comprehension of critical information, operating procedures, and regulatory requirements. For more than 25 years, EduNeering has been integrating expertise in business, learning, and technology to deliver comprehensive knowledge solutions. Leveraging a suite of standard and custom courses, technology-based systems, a range of professional consulting services and industry-leading partnerships, EduNeering responds to client needs for employee excellence in a world of fast-changing regulations, technologies, and economic demands. EduNeering, with headquarters in Princeton, N.J., has offices in Houston; Bloomsburg, Pa.; and the United Kingdom. For more information, visit eduneering.com. June 2005 VIEW on Clinical Services

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