Study sponsors have vast amounts of clinical trial data. Managing clinical trial data in an accurate, efficient, cost-effective, and secure manner is critical for analysis of endpoints and creation of the Clinical Study Report, but management of such data can often pose a challenge for sponsors. Additionally, sponsors are challenged to provide quick access to data in order to gain insights from it.
Today, the majority of clinical trials are conducted with the use of electronic data capture (EDC) systems. An EDC efficiently records and processes clinical trial site data, investigational product data, and patient randomization; as well as, captures data according to the study protocol. However, an EDC alone is not enough to ensure clinical trials are conducted efficiently, accurately, and in compliance with national and local regulatory requirements. A trained clinical team is essential for these functions, and the team can use data captured through an EDC to provide meaningful insights into clinical trials.
Composition of a trained clinical team
Collectively the clinical team handles all aspects of a clinical trial from patient identification and enrollment, providing care according to the study protocol, entering patient data into the EDC, reviewing trial data for completeness and accuracy, reporting and acting on adverse events, analyzing data for trends, summarizing data so that it is easily understood by non-statisticians, and ensuring the data meet quality standards and comply with the protocol, good clinical practices, and local regulations.
A trained team is comprised of professionals in various roles employed by study sites, trial sponsors, and CROs.
Trained clinical teams benefit from EDCs
An EDC system is most effective when used by a trained clinical team. A trained clinical team will use an EDC to review data in real-time in order to:
- Identify trends
- Identify personnel that need additional training
- Report on key study metrics such as enrollment rates, serious adverse event rates, protocol deviations, and patient compliance with the study protocol
- Identify if a protocol needs to be amended
- Determine if study enrollment can be stopped early because enough data has been collected to reach the primary endpoint
- Determine if a clinical study should be stopped due to safety concerns
The clinical team can review data through the EDC in real-time as it is entered by the study sites, and this significantly increases efficiency and reduces the time needed for data entry from paper case report forms (CRFs).
Industry challenges solved through synergistic use of trained clinical teams and EDCs
There is quite a bit of interest in moving clinical trial monitoring to risk-based monitoring (RBM); however, clinical trial sponsors and clinical trial professionals have been slow to adopt these new approaches to clinical trial monitoring.
At the center of RBM is a move away from the traditional monitoring approach of frequent on-site visits and 100% source data verification (SDV) toward a combination of activities, including centralized data collection and monitoring. The FDA recognizes that an approach focused on the specific risks for each specific clinical trial is more likely to ensure the safety of patients more than routine visits and 100% SDV.
While adoption for RBM may be slow to date, pressure to conduct clinical trials more efficiently and to need to gain insights from clinical trial data will drive adoption of RBM in the near future.
Recommendations for successfully combining a trained team and an EDC
A trained team is comprised of professionals in various roles employed by study sites, trial sponsors, and CROs. Benchmarks of an experienced and well-trained clinical team include:
- Principal investigators and study sites–Ensure investigators and study sites have previous experience conducting clinical trials in the specific study phase and therapeutic area.
- Sponsors and CROs–Ensure professionals are in place to fulfill roles such as clinical research associates, clinical project managers, clinical data managers, biostatisticians, and quality assurance managers.
An experienced and well-trained clinical team is critical to ensuring the success of a clinical trial. Begin with an evaluation your team’s ability to fulfill the critical roles of Sponsors. If your team is not able to fulfill these roles, we recommend you partner with a CRO to do so. For insights into the essential mix of education and skills Clinical Research Associates (CRAs) need to be effective, see this blog post.
Recommendations for working effectively with Study Coordinators
Study Coordinators fulfill an important role of entering data into the EDC system. Keep in mind that Study Coordinators use different EDC systems for each clinical study, and each EDC system operates differently. It can be a challenge for Study Coordinators to complete routine tasks such as answering queries, navigating the system, and customizing dashboards. To make it easier for the Study Coordinators consider the following:
- Select the most efficient and effective EDC system based on the complexity of the study protocol
- Customize the eCRF to only collect data needed for regulatory review and submission for approval (resist the urge to ask for additional data that would be “nice to have, but not necessary” as this takes more of the Study Coordinator’s time to enter data)
- Create custom guidelines for completing the eCRF based on the study protocol and with your EDC system
- Encourage Study Coordinators to reach out to the Clinical Data Managers to help resolve queries and provide additional training when it is needed
- Provide regular and on-going interactions with the study sites to review study data as it is entered into the EDC
Study sponsors have vast quantities of clinical trial data, but leveraging clinical trial data in an accurate, efficient, cost-effective, and secure manner is a significant challenge for sponsors. Utilizing an EDC to capture study data is not enough–a trained clinical team in combination with an EDC system is more effective, efficient, and can provide insights into the clinical trial throughout the duration of the trial.
I’d love to hear your thoughts on how you have successfully combined an experienced clinical team with an EDC to speed up clinical trials and submission of trial data to regulatory authorities. Please share your comments below.