By Neil Warnock, M.D.
The costs of clinical trial operations are continuously being evaluated for ways of achieving greater efficiency while reducing expenses. Many biopharma companies, now more than ever, focus on containing costs while maintaining quality. This approach applies to eClinical technology used to support a trial. An eClinical solution should include best-in-class integrated technology that is cost-effective, high quality, and efficient.
An example of this type of technology used in clinical research is electronic data capture (EDC) combined with interactive response technologies (IRTs) such as IVR (integrated voice response). This software combination has proven effective in reducing the cost of clinical trials. These integrated solutions will increase the efficiency of a clinical trial and provide a single environment with the flexibility and scalability to keep pace with demands.
Most of the integrated eClinical solutions are the result of single technology solutions that are paired together or integrated into a suite of eClinical solutions, resulting in a single platform with multiple components such as EDC and IVR. Comprehensive multicomponent solutions that contain EDC/IVR/CTMS (clinical trial management system) labs built from the ground up as a single integrated solution are uncommon and rarely best-in-class.
The emergence of integrated solutions results from the need to gain access to central lab data, EDC, and IVR data, including ePRO within a single system in the fastest, most reliable manner. As integration solutions have evolved, the continuous challenge is to improve the level of data integration beyond a transfer or sharing of flat files to true integration.
One of the drivers for data integration resulted from the FDA’s critical path initiative, focusing on the use of technology for the creation, evaluation, and approval of new products. Statisticians reviewed the data collection process required for adaptive clinical trials and determined it would work with real-time access to data. With adaptive clinical trial design, decisions are made while the trial is ongoing to maximize resources and minimize failures. IVR helps reduce drug waste, providing better control and better access, especially with multicenter interactions, creating a more nimble approach to controlling drug supply. IVR deployment supports just-in-time activities, including drug shipping and packaging.
Take Your Time With Vendor Selection
One of the most important, and difficult, decisions a company has to make is selecting the right vendor for any of the multitude of eClinical (EDC, CTMS, IVR) services when conducting a clinical trial. Vendor selection commonly defaults to a familiar software platform, often based on previous experiences, irrespective of cost, ease of use, or true best-in-class performance. Choosing only from high-profile, high-ranking vendors may be risky. These vendors may fail to meet specific needs of vertical markets or other more specialized segments. The capabilities of these eClinical systems are proven; however, positive results are often achieved only after enduring many resource challenges, including an inordinate amount of staff time dedicated to learning highly complicated solutions.
The Benefits Go Beyond Real-Time Data Access
One of the benefits achieved by integrating data sources in real time includes immediate access to various forms of clinical data, including central lab, IVR, and EDC data. Having immediate, online access to this kind of data can reduce errors while continuously reconciling and minimizing data redundancy.
Using an integrated EDC/IRT approach eliminates the need to log in to multiple systems, such as screening and randomization, medication dispensing, patient reported outcomes, or diary data and patient events. The end user at the site now has access to all randomization and trial management capabilities, with full assurance on the quality and reliability of data shared between applications, eliminating redundant data capture across technologies, combined with a centrally held audit trail of activity. Data collected or generated by IRT should be automatically passed to the EDC system.
Overall, the CRO or sponsor that selects a vendor with an integrated IRT/EDC system benefits by using a system that preserves the best features of both technologies, eliminates duplication of efforts, and saves time and money. Working with an integrated platform also eliminates possible mismatch between systems, while allowing the end user to perform tasks through a familiar route.
About The Author
Neil Warnock, M.D., MBA, MS, a life science and healthcare consultant, has worked in drug development, managed care, and clinical performance management. He is currently serving consultancy roles as chief medical information officer, chief medical officer, and chief research officer.