Most clinical trials today are being conducted on a global level with vast amounts of clinical data to collect, analyze and report. Trial strategies include collecting clinical data from multiple sources and sites, ideally in real time so Data Managers can manage discrepancies and unusual data patterns and Biostatisticians can analyze incoming clinical data and make critical decisions on trial progress.
Therefore, when implementing a global data strategy, what factors should Sponsors consider in order to ensure efficient project management, timely and quality data and cost-effective measures? CROS NT guides you through some considerations:
1. Which technology solutions are best for managing vast amounts of data?
The obvious solution may be to consider an EDC solution for clinical data management which can organize multi-language, global study data into a single database. Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study into the eCRF. Query management is accelerated, and any inconsistencies in CRF or ePRO data can be checked in real time.
A cloud-based EDC system can eliminate the need to invest in an IT infrastructure while reducing training efforts. Cloud-based clinical applications also guarantee better data quality and data security through secure data transfer connections.
However, Sponsors should also consider eClinical platforms that include ePRO integration, CTMS and IWRS to manage all aspects of a clinical trial. It is important to note that not all EDC systems and/or eClinical applications fit all studies, so Sponsors should consult their CRO on which system is best.
2. Consider a Centralized Statistical Monitoring Approach
Centralized monitoring has been proposed as a new, more efficient approach to on-site visits. A CSM approach can be useful in detecting faulty equipment errors, negligence or fraud, protocol deviations and unexpected data patterns which then identifies the sites that need further investigation. CSM has been suggested as a cheaper and more efficient alternative to on-site monitoring. Combining CSM with EDC and Clinical Data Visualization solutions can make monitoring extremely efficient and cost effective.
3. Should clinical data be centralized?
A centralized biometrics approach promises Sponsors:
- One relationship between the biometrics CRO and Sponsor and team continuity
- Better integration of studies across all phases with common assessment methods and data standards
- Uniform traceability of data
- One set of biometrics Standard Operating Procedures
- Centralization of study metrics and reporting
- Cost reduction through the re-use of global libraries (savings up to 40%)
The clinical data team is crucial to success and it’s important to have team continuity throughout global data projects. Sponsors should work closely with CROs to put together the best team of project managers, statisticians, data managers and medical writers. By centralizing biometrics, Sponsors can be ensured of the same biometrics team from start to finish. This is particularly important when it comes to the biostatistician who can provide insight from protocol to reporting through all phases of the development process.
Sponsors can also look to implement the Functional Service Provision model in which teams are assigned to a certain project for a fixed period of time. This allows the Sponsors to cover peaks and troughs in the workload while having a dedicated biometrics team.
5. Making Sense of Clinical Data: Biometrics Consultancy
Many challenges present themselves through the drug and device development process. Sponsors can’t be prepared for all issues that may arise: from trial design and sample size recalculation to regulatory challenges, sometimes Sponsors need help making sense of clinical data on a case-by-case basis. Having an expert biostatistician, data management expert or quality assurance professional available for consultancy can help Sponsors resolve small issues that arise during trials but have the potential to make a big impact.