This means that Ajax, which is an open, nonproprietary technology and an approach to programming rather than a product, can be used to create a thick-client work environment using a thin-client browser. The significance is that clinical data management has traditionally been a process involving entering patient clinical data from three-part NCR forms into a thick-client data management system, where rapid “heads down” data entry with hot keys could speed the data entry and cleaning process. Recently, the advantages of using thin-client Web-based EDC systems has gained significant acceptance because of the speed and time savings provided in cleaning and locking patient data. Unfortunately, these systems have been developed as two different systems based upon different technologies requiring different processes.
Using Ajax, browser-based applications can recreate the efficiency of the double data entry environment — complete with the hot keys, custom tabbing, and dynamic loading — that previously was only found on custom desktop applications. This means clinical trials software vendors will be able to provide the functionality of the thick-client desktop-like system in a thin-client Web-based system that could be used anywhere.
Using Ajax technology to unite PDE and EDC solutions within a single clinical trial will provide substantial benefits for pharmaceutical companies and CROs. Certainly the momentum is growing for EDC solutions, with the growth of EDC adoption running at an estimated 10 to 15 percent a year. But that means we are looking at a transition period that will continue for some years.
Some of the benefits from using Ajax to unite paper-based and EDC approaches into a single browser-based solution include:
- Reduced validation costs. FDA regulations under 21 CFR Part 11 require validation of all computer deployments being used for clinical trials. When using double data entry, this means that software needs to be tested and documented, and the environment needs to be secured. If any data reside on the data input system, they need to have a documented backup schedule. Because of the costs of sending a compliance validation inspector into the field to examine desktop computers, people have not been able to work from remote locations such as from their home. But such site inspections aren’t required if the person is simply using a Web browser to log onto a secured server. This new capability has the potential to redefine how the data entry workforce is engaged as advances in distributing phone calls did for the call center support industry.
- Savings on training and support. When separate systems are used for PDE and EDC, separate training and support programs are required. The cost of training and support is reduced when unifying PDE and EDC with a single system that handles the backend data consolidation, cleaning, and storage.
- Ability to create hybrid systems. Ajax technology allows you to create true hybrid systems that support both PDE and EDC. This makes it easy to include sites that can, for example, only support PDE while the data from other sites are collected using EDC.
- Unified data management. Using Ajax to unify PDE and EDC means data management can be conducted from anywhere in the world at any time through the browser by a distributed workforce.
Ajax — a standards-based approach to creating solutions, available to all at no cost — will simplify the collecting of clinical trials data. As the industry moves toward EDC, Ajax technology can smooth the way.
Nick Richards is COO of DataLabs. E-mail: firstname.lastname@example.org.