Everyone who conducts clinical research understands the importance of saving time and the need to do more with fewer resources. To best achieve this goal with data collection, new methods are needed. The successful researcher is continually changing with technology and is adaptive.
Using Traditional Methods
When developing a process for opening clinical trials at your site, it is not unusual to start with simple tools such as Microsoft Excel or Word. Funding issues may result in the use of other methods to capture data, such as spreadsheet files. This adaptive approach may work well in the short-term to bring new treatments to patients faster. However, if older technologies continue to be used moving forward, there will be challenges down the road when verifying data and gathering endpoint conclusions.
Within the clinical research industry, there are individuals that have made a career as a “study salvage expert,” also known as data clean-up specialists. A specific example that comes to mind is the Excel challenge. Over 50 subjects were enrolled to a clinical trial and research charts were kept, but the database was too basic for the type of information being collected. The ability to sort and search for terms was missing. In addition, the rows and columns were not kept frozen by all users, which ultimately compromised the integrity of the data because subject ID numbers were absent on the next worksheet. This required hours of manpower to check charts and verify the initial data entry. With this example, it’s easy to see why it’s better to collect data properly from the beginning.
Other data collection tools have a bit more foresight and relational database tools, such as Microsoft Access. However, this option is not very user friendly and database files can easily become corrupted, resulting in data loss.
Another method uses CRFs that are faxed into a database, with the faxed information stored in a computer software program for quick turn around for the sponsor. At the end of the study, those original CRFs are sent to the sponsor. Obtaining copies of the original CRFs, then, becomes a huge concern for clinical sites since photocopies are not typically generated at the time of transmission. This requires clinical sites to provide additional support that may not originally be in the sponsor agreement. Additional time is needed for verification of data collection since clinical sites need to photocopy and file all original CRF documents.
By using electronic data capture (EDC) software from the beginning, many critical tasks can be completed with ease. For example, with an EDC system, it is possible to quickly create summary reports for study abstracts. Study endpoint data can be tabulated easily for biostatisticians for end of study statistical summaries. There are many other advantages to an EDC system, highlighted below.
Watch our free, on-demand webinar to learn different methods of data collection in clinical studies and how they compare to an EDC system.
Secure access to data is extremely important. Within an EDC system, only certain users are able to update data files, preventing file corruption and errors. Because user roles are restricted within a system, they have clear boundaries as to the scope of work they perform. This gives the data management team the ability to easily identify users who may need to revise a form or provide insight for fixing any errors. Additionally, critical tracking of data entry can be achieved by the use of an electronic audit trail.
The most important part about conducting research is consistency. This is best achieved by having standard data collection tools. By utilizing the same training materials and standard operating procedures, it is possible to eliminate inconsistencies and other factors that jeopardize the quality of research data. Collecting consistent data across studies can be accomplished by using standardized data collection forms in an EDC system.
EDC systems provide a standardized method for data collection that minimizes user bias and other complicating factors that could affect results. In order to achieve the best results, it is critical that a solid data collection plan is fully implemented. With exceptional plans and a detailed road map, you will produce the desired high-quality results.
Time constraints are always an issue when managing resources. Projects that have a greater burden on site staff are often passed from person to person and may lead to team burnout. By utilizing EDC roles and methods for data collection, these challenges may be solved. The time spent on a trial is not necessarily related to the type of study visits or the number of visits per treatment cycle. Instead, the workload can often be related to the process of data capture.
Using an EDC can also save time in areas that may not be as obvious. For example, it is not unusual to consider opening a second research site in order to achieve enrollment goals within the required timeline per protocol. Having an EDC system up and running is critical to quickly opening an additional research site.
Another advantage to EDC is the ability to remotely access your trial data without having to be present at the office or medical center. Having data stored “in the cloud” is the best way to review up-to-date enrollment information and receive email updates on the latest events for patient safety and overall study progress.
By understanding how each project may fit into a unique EDC system, it is possible to create a competitive advantage. While traditional methods of data capture may still be a suitable option for some projects, electronic data capture is quickly becoming the preferred method due to the ease of use and affordability of systems. However, it is important to find a system or method that works best for your site. An adaptive approach to EDC is needed to ensure that data collection is 100% electronic, saves time, and produces desired results for the entire clinical research program.