Clinical research is only as effective as its impact on the health of patients. To maximize the impact of clinical research on patients’ health, clinical trials must be conducted in a highly structured and closely coordinated manner, thus producing data that is easily accessible, traceable, interoperable, and reproducible. Standardization, centralization, and specialization are three key factors that can play an essential role in the smooth and efficient running of clinical trials. However, most clinical trial sites often overlook these factors.
Let’s take a closer look at these three elements.
1. Standardization
Standardization of care processes in a healthcare system, using tools, such as order sets and protocols, has resulted in significant improvements in patient outcomes. For instance, in an observational study evaluating the impact of standardized order sets in pneumonia patients, the use of a standardized order set resulted in a 33-34% reduction in in-hospital mortality.
The same principle of standardization can be applied to improve outcomes in clinical trials. For example, the implementation of standardized systems and procedures can assist the research staff in managing the complicated processes involved in clinical trial conduct. Some of these standard procedures may include using formalized templates to report findings, providing standardized training for all team members, and standardization of equipment across the clinical trial site.
Clinical data standardization is another vital way of process improvement and cost control. Collecting data in a standardized way reduces the time-consuming efforts that may harm resource utilization and development timelines. Both sponsors and regulatory agencies are beginning to realize the significance of adopting a common set of data standards. The Clinical Data Interchange Standards Consortium (CDISC) Foundational Standards are now increasingly being applied to standardize clinical trial processes. Adopting these data standards helps improve the data collection, analysis, and reporting process, and in turn, may enhance the efficiency, quality, and safety of clinical trials.
2. Centralization
Centralization allows research sites to optimize resources and streamline research operations. Sites that do not utilize a centralized model, simple tasks, e.g., updating rosters, licenses, or CVs, may be performed for each study by as many as five separate people. On the other hand, a centralized approach allows one or two team members to complete the same tasks consistently for all the studies making the process faster while reducing the risk of errors and inconsistencies associated with multiple people performing the same job differently. Moreover, a centralized system allows the research coordinators to focus more on other clinical and patient-related activities.
Similarly, having a centralized system for collecting and storing clinical trial data enhances the accessibility and safety of data. It also results in better outcomes related to regulatory compliance, as regulatory issues can be identified and mitigated in time.
3. Specialization
The origins of medical specialization are traced back to the nineteenth century when the consensus began to form that specialization is necessary to provide more efficient and higher-quality care to patients. The first specialty board (ophthalmology) was established in 1917 in the United States, and the development of several other specialties followed shortly. Now, there are more than 120 medical specialties and sub-specialties. In general, specialization correlates with a positive impact on the provision of healthcare. For instance, in a study conducted in South Korea, hospital specialization was associated with a shorter length of hospital stay and decreased medical expenses. According to another study, a mean 10% increase in hospital specialization reduced a patient’s hospital length of stay by 8 hours.
The benefits of specialization in the healthcare industry are evident. However, specialization does not seem to have been widely adopted by the clinical research industry as of yet. For instance, a research coordinator at a clinical trial site may be responsible for patient recruitment, administrative duties such as study start-up activities, and regulatory support. However, suppose the role of a regulatory specialist is assigned to a specific team member. In that case, this takes the administrative duties off of the coordinator and allows them to focus more on clinical and screening activities. Similarly, the roles of billing or recruitment specialists can be assigned to different staff members, thus, reducing the workload on any individual.
Role of technology
Modern technology can play a critical role in implementing the principles of standardization, centralization, and specialization in clinical trials. For instance, clinical data standardization and centralization can be achieved with the use of a digital platform that assists in the collection of data in a standardized fashion with the storage of this data in a centralized location. In addition, utilizing an electronic system can exponentially multiply the effectiveness of a specialized person assigned a particular task by standardizing the workflows and reducing duplicative and repetitive work.
Standardize, centralize, and specialize with Clincal.ly!
While the benefits of standardization, centralization, and specialization in the healthcare industry and clinical trials are apparent, practical implementation of these components may not be simple and require industry experts’ assistance.
Clincal.ly is a modern technological solution provider with the mission of putting you in control of your clinical trial software. At Clinical.ly, we understand the importance of standardization, centralization, and specialization in optimizing research operations. We deliver standards-based, expert technological solutions and streamline clinical research by implementing these elements at your trial site.
Get in touch with us today, and let us help you standardize, centralize, and specialize!