Strategies to Minimize Site Burdens and Maximize Data Cleanliness for Registries and Observational Studies

December 12, 2008
Mike Hill

,
Eunice Franklin-Becker

Applied Clinical Trials

Adaptive EDC: 5 Strategies for Minimizing Site Burden, Maximizing Data Cleanliness for Registries and Observational Studies

Mike Hill, Project Manager, Registries & Observational Studies, Periapproval Services, Covance; Eunice Franklin-Becker, MPH, Project Manager, Registries & Observational Studies, Periapproval Services, Covance

 

Adaptive Electronic Data Capture (EDC) solutions have proven to be a very valuable tool for efficient collection of study data. Through the proper implementation of programs using EDC, companies are able to realize a very high return on investment from their data over the full course of research programs. While the gains from successful implementation of these programs are high, there is also significant risk associated with EDC solutions.

An adaptive EDC strategy is one way to mitigate risk, but implementation can be challenging, as there are many factors that must be considered. The success of a study using EDC depends on two key components; minimizing site burden while maximizing data cleanliness. This article outlines five strategies for successful implementation of EDC programs which have been developed from years of successful execution of adaptive EDC strategies.

Minimizing Site Burden, Maximizing Data Cleanliness
Since 2003, the pharmaceutical industry has been experiencing a rapid shift to EDC, especially in registries and observational trials. Historically, registries have required simple data capture with minimal data cleaning requirements. Due to the large cohorts of patients typically involved in a study, the programs were often run via an EDC solution.

More recently, pharmaceutical companies have more stringent expectations on data cleaning, which impacts the EDC solutions as well as sites. Higher expectations coupled with the longitudinal nature of these programs and the application of adaptive EDC makes minimizing site burden of utmost importance. When an adaptive EDC strategy is successfully executed, sites remain willing to enter data and resolve the queries that are generated to maximize data cleanliness.

Strategy #1: Develop a Streamlined Protocol and Site Activation Process
Steps to minimize site burden should begin with the launch of a registry program, starting with the design of enrollment materials. Developing a streamlined protocol and recruitment documentation helps to ensure that sites are activated for data entry through a straight-forward and timely process. Additionally, regulatory packets can be far less rigorous than earlier phase trials.

The IRB approval process is the team’s next opportunity to minimize the burden a site faces during the activation process. For registries and observational studies, sites can often function under the blanket approval of a central IRB. In the event that a site must obtain approval from their local IRB, they may request expedited review which often saves both time and money by reducing approval times.

Strategy #2: Ensure Ongoing Site Communication and Support 
For all sites participating in a program, ongoing site communication should be a team priority. Establishing solid working relationships and providing adequate support early in a program will help to keep site morale high and burden low. As the EDC solution adapts to changing study needs, training methods must be revised which will warrant ongoing communication in the form of continuous and adaptive site training sessions. 

Once sites are activated, it is important to recognize that participating sites may have limited research experience. Experience has shown that in larger registry programs, a significant percentage of participating sites are smaller, community-based practices that are research-naïve. It is important to provide these sites with streamlined study administration and support via newsletters, user manuals, and web-based support documents- all of which are a fundamental to the support of sites for an EDC-based program.

Comprehensive written instructions and user manuals are also a very helpful form of communication. Newsletters that explain changes before implementation will ensure that sites have time to ask questions. Worksheets with space for proactive data collection can provide sites with tools to get a head-start by pulling charts and collecting data prior to the implementation of the EDC changes. All of these strategies help reduce site burden as well as maximize data cleanliness through simple communication.

Strategy #3: Implement For-Cause Monitoring 
For-cause monitoring is another efficient strategy that can go a long way to minimize site burden. Monitoring visits are time consuming for site staff, and as registries and observational trials often do not impact the chosen standard of care, there is no immediate need for routine monitoring visits. Having a strategy for implementing for-cause monitoring only as needed allows data quality to be maintained with minimal added burden to sites. Criteria for these visits may include an unusually high number of queries; excessive or too few help desk calls; failure to enroll; and/or high staff turnover at the site.

Strategy #4: Strategic Implementation of EDC
In a recent survey of site personnel, ease of eCRF completion, ease of system navigation, and form flow were cited by 83% of respondents as the most beneficial attributes of EDC. (1). User-friendly solutions are key to reducing site burden and encouraging participation. Streamlined software applications, such as Focused Response eCRFs allow sites to easily add patients and patient data while resolving queries to ensure clean data capture.

During the initial CRF design, steps should be taken to maximize ease of use, including the use of drop down menus and check boxes to avoid open text options. Maximizing front-end queries will also help to ensure clean data as these are entered directly into the application, thereby eliminating the need for sites to go back to resolve queries. Disabling forms, pages, questions, and selections through the appropriate use of skip-patterns ensures that sites only see data points that must be addressed.

Strategy #5: Commitment to Project Management
A final component that is central to minimizing site burden and maximizing data cleanliness is a commitment to project management and recognition of the shared responsibilities of the Project Manager and Data Manager during the implementation of adaptive EDC. For adaptive studies, it is essential that the Project Manager has a firm understanding of the data management side of the program. Additionally, the Data Manager must have a firm understanding of the clinical team’s role. When implementing adaptive EDC, it is important that these two individuals maintain a comprehensive understanding of the program and work in close partnership to anticipate and manage any challenges that a particular change could create.

The Project Manager and Data Manager must also work together on study timelines to ensure that the team moves forward together. Timelines in these programs are of the utmost importance as sites must be provided with time to adapt to the adaptive change. Implementing changes without providing sites with adequate time to adapt contradicts the project’s goal of minimizing site burden while maximizing data cleanliness. When sites are not provided with adequate time, stress is created by the small window for resolving queries prior to data cuts. A worst-case scenario is one where sites do not resolve queries, thus the data cannot be used for analysis, which can dramatically increase site burden and ultimately result in dirty data or sites withdrawing from the program.

Conclusion
As the biopharmaceutical industry continues to evolve and more emphasis is placed on post-marketing trials, the need for adaptive EDC solutions will increase. Experience and research has underscored the importance of the strategies outline in this article as a means of minimizing site burden and maximizing data cleanliness in adaptive EDC solutions. While the implementation of adaptive EDC can be a challenging process, when properly implemented the data collected will remain relevant and valuable for years to come.

 

References

Franklin-Becker, E. Electronic Data Capture as a strategy to enhance complete data capture, site satisfaction, and participation in registries and observational studies. Drug Information Association, Annual Meeting, Boston, MA, June 2008. (Presentation)

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