Supporting EDC in a Clinical Trial Environment

To bring new products to market faster, and to reduce or contain the cost of drug therapy development, pharmaceutical companies are looking to optimize processes in order to yield greater efficiencies, particularly in the clinical research and development area. To reduce product development costs requires solutions that will help pharmaceutical companies identify, early in the development process, which compounds to pursue, which to abandon, and how to streamline the clinical trials process.¹ Introducing new technologies to create greater efficiencies has actually resulted in bottlenecks. Systems are larger and more complex, and fewer team members understand the complete system, which in turn has increased the numbers of specialists on any given team.

Benefits of electronic data capture
With the ongoing uncertain economic times and skyrocketing clinical trial costs, pressure to find ways to shorten and improve clinical trial processes has increased within companies. Areas particularly targeted for improvement are the quality of data collected and the speed at which it is collected. For paper-based trials it takes 125 days to enter and send 89% of the data, and a mean of 149 days to get clean data.² Through electronic data capture (EDC), 89% of clinical trial data are entered and sent within a week, with a mean of 22 days to clean data. Also, new FDA regulations (for example, 21 CFR 11) create an environment that facilitates and encourages electronic data capture.

A recent Forrester Research study found that more than 50% of trial professionals would prefer to do trials using Web-enabled EDC in place of paper and that two-thirds think sponsors should make the change happen.³ The infrastructure for Web-enabled EDC focuses on a secure Web site where the data are directly entered into an electronic case report form (eCRF). The data entered can be immediately edit-checked, thereby reducing the number of queries and the need for clinical informatics technicians to double-enter the data. The Web infrastructure can link trial investigative participants (such as monitors and sites), and it supports their access to the data, so that the eCRFs can be searched, reviewed, and audited for incomplete and/or inconsistent data. According to Gartners Dataquest,1 the integration of business processes and supporting technologies of sites, investigators, contract research organizations (CROs), and pharmaceutical companies produces the benefits of EDC. The value of EDC lies in the ability to enable collaboration across the clinical trial value chain. Likewise, Forester advises that dynamic collaboration grows out of Web EDC.

Use of the Web to complete case report forms and the use of electronic subject diaries provide improved access to clinical data, improved query resolution, and reduced errorsall of which lead to improved trial management.

EDC may also reduce the number of monitoring visits required by the clinical research associate (CRA). Because CRAs have access to the trial data and can generate queries remotely, site visits can become fewer but more effective. CRAs can focus on other responsibilities, such as source data verification.

In the past, many felt EDC would alienate doctors. But faster query resolution translates into shorter CRA visits, which can be a source of disruption to the office. Many also felt transmitting data over the Internet posed unacceptable security risks. But as other industries, especially banking, have adopted Web-based transactions, pharmaceutical executives are becoming more confident that proper security will safeguard communications of subject data.

An adequate support process
With Web barriers falling, it appears that clinical trial sponsors will adopt EDC and leverage EDCs core capacity to improve communication between clinical research coordinators (CRCs) and CRAs. Because sponsors determine how the trials are conducted, they are uniquely suited to offer the applications and make the system operational. Wth this position comes the responsibility of ensuring that the necessary new procedures are developed in order to attain maximum value not only for themselves, but also for the sites.

Understanding the proper support needed for each site is crucial, particularly when trials are conducted in areas other than North America or Western Europe where pharmaceutical companies, seeking to contain costs, can make use of the large number of available study subjects within countries that have a diversity of disease, favorable regulatory climates, and a significantly lower cost of living. Depending on the location and culture, there may be significant differences in technical environment and knowledge. Sponsors need to assess this during their site screenings in order to set up the sites for success with an EDC trial.

Standards for technical support
The International Organization for Standardization (ISO) maintains a set of world-recognized quality standards used to demonstrate a companys ability to meet customers, regulators, and the organizations own internal requirements. The new version of ISO 9000:2000 requires companies to adopt the process approach when developing, implementing, and improving the effectiveness of a quality management system. This approach emphasizes the importance of

• understanding and meeting requirements.
• the need to consider processes in terms of added value.
• obtaining results of process performance and effectiveness.
• continual improvement of processes based on objective measurement.

Because EDC requires supporting technology (such as hardware, software, and browsers), which is not required when using paper case report forms, implementing EDC involves a whole new set of processes. A smooth transition to EDC requires assessing the technology available to the sites and their technological proficiency. Depending upon the assessment, the validated computer equipment necessary for EDC may have to be deployed in a systematic manner. IT help desk support aligned with global hours of operation must be initiated. Additionally, offering IT support in the native language enhances communication and may reduce incident resolution time.

Measuring clinical trial processes and methodology for site assessment, deployment, and help desk with international standards, and certifying each trial against the standard so that a consistent level of support is ensured, contribute greatly to the success of an EDC implementation.

How the help desk can help
Obviously, a critical success factor is providing, in the native language, a consistent level of support for remote sites and clinical trial processes independent of geographical location. The corporate help desk setup is not designed to support the disparate sites that are involved in clinical trials. It tends to work in a standardized environment where both hardware and software configuration are clearly defined, with users having the basic skills to operate the tools they have to use. The medical and pharmaceutical communities are late adopters of Web-based technology for clinical trials because of the concern that the technology might not perform optimally and the belief that data are only secure and under control while on paper.

Multisite technical support should be performed in a structured, professional way that complies with international standards. Good support not only avoids the technical problems but also addresses the emotional reluctance to use new technologies. To obtain the greatest efficiencies, service-driven process service level agreements (SLAs) need to be put in place. Using the Level 1 help desk support groups to the maximum extent possible will produce the greatest benefits. By using knowledge-based solutions, help desk agents can access the necessary information and provide the clinician with a swift answer. The Level 1 help desk can also qualify those requests that need to be escalated, gathering and confirming the necessary information to be sent to the second level. Via the Web-enabled front end, the escalation group receiving the incident has full access to all data, including the complete history of the request and the actions taken. If appropriate, the new problem solution can be captured in the knowledge base as a new article and made available to all authorized levels.

In addition to hardware and software support, the Level 1 help desk can also be deployed to prequalify the sites elected to participate in a trial. Support techs can evaluate the system and connectivity environment using client-approved templates, and if necessary, supply the site with fully staged equipment that has been validated and configured in accordance with the companys standard for the trial. Equipment deployed would be tracked using asset management software, and local connectivity arrangements could be made if lacking at the site. Upon confirmation of equipment receipt, a follow-up call is initiated by the help desk to test the connectivity connection and verify functionality.

Native language, local time zone
The ability to communicate in the native language reduces anxiety and expedites the incident resolution process. Translation services are cumbersome and lack the comfort level associated with having the help desk agent communicate with the clinician in his or her native language, both to secure the details of the incident as well as communicate the solution.

Support needs to be available in the sites local time zone so that concerns and problems can be expeditiously communicated and resolved. Delaying incident resolution because of time differentials could potentially compromise the quality of the trial.

While these may seem like obvious services to offer sites, sponsors need to ensure that the vendor they are working with can support these services or has partnered with a vendor to provide them.

The importance of training
Successful deployment and implementation of hardware and software at remote study sites requires both a thorough understanding of the requirements and appropriate planning. Training to ensure an acceptable level of self-sufficiency is essential to the success of an EDC trial. This training should be composed of standard courseware and focus on common topics and common skills. If the design of the trial necessitates a unique skill, custom courseware should be developed for that specific functionality. Training should also comply to international quality standards to ensure that the trials deliverable is consistent, independent of geographic location.

Training, either standard or custom, must be scheduled at convenient locations and conducted in the local language to ensure that all trial investigative participants understand the application and are comfortable in the use of the technology. Study sites knowledge of the system and its underlying application is the largest single factor affecting the success of an EDC trial. Training is essential to instill the knowledge, which may assist in reducing or containing costs and securing quick approval of the New Drug Application (NDA).

Gartner Dataquest recently stated that numerous vendors offer key functionality to support the clinical process.1 Pharmaceutical companies can partner with these organizations to provide the proper support to their sites. EDC can dramatically improve the clinical trials process, but only if investigator sites are comfortable with the technology and embrace it as a more efficient method of data collection. To help site personnel who are accustomed to paper actually embrace the change to EDC, sponsors need to ensure that they receive the best support structure available.

References

1. Clinical Trials: Identifying Portal and Marketplace Opportunities in the Pharmaceutical Industry (Geraldine Cruz, 56 Top Gallant Road, Stamford, CT).

2. A. Lawton, Boehringer Ingelheim, Barcelona 2001.

3. Web Clinical Trials Breakthrough (Michael J. Barrett, 400 Technology Square, Cambridge, MA).