Clinical trials are by no means inexpensive and failure is not an option. Here are some ways to prevent such issues.
Start by investing in data quality
Most sponsors do not define a clinical data strategy including plans for the entire phase of development, which includes postmarket, from the beginning. For efficient query management and database build and management and because clinical data is the greatest asset of a sponsor, companies need to invest in an experienced and knowledgeable clinical data team.
A biostatistician should be involved from the start and a consultant statistician should be kept on the team during the entire development cycle.
Involving a biostatistician in a trial from the start can help the biostatistician understand the study design, which helps the biostatistician offer proposals on hypothesis testing and analysis. Statisticians play a major role in data management, monitoring, and reporting and protocol development and design.
It is important to keep a consultant statistician on the team during the entire study because the consultant statistician alleviates problems arising with trial design and data analysis and the statistician reports to regulatory feedback. If you’re interested in such a career – take a look at ICON to know what you need to accomplish it.
If necessary, statisticians apply trial design methods like adaptive trial design that could make noteworthy changes in the study, which include timelines and early study termination. Additionally, statisticians can help make sense of clinical data and they support in DSMB and regulatory meetings.
Use a specialized vendor to centralize clinical data
Sponsors usually face difficulties with data inaccuracies, data traceability, query management, and cross-product analysis if the data is dispersed across vendors. To save time and have easy access to study metrics, use centralizing clinical data services, which include biostatistics, medical writing, and data management, to create a global library of databases and a short learning curve between sponsors and the contract research organization (CRO). Standardization and getting familiar with customer processes, templates, formats, and communication can help improve quality.
Address staff augmentation and turnover by implementing a strategic Functional Service Model (FSP)
Functional Service Model (FSP) improves the quality and eradication of change orders, increases efficiency and reduces training by facilitating a scalable, expert team of resources for a particular function. Therefore, sponsors can use FSP to save on HR management time, recruitment fees, and training costs.
The CRO ensures continuity of trained resources and produces the required resources, which guarantees the sponsor that the resources dedicated to the project are the same and the resources understand the requirements of the CRO and sponsor. Small companies, which require less than 10 resources, should consider a scaled-down version of FSP known as “Micro FSP”.
Implementing technology such as risk-based monitoring and EDC
To keep costs under control, use low-cost options technologies like electronic clinical outcome assessment (eCOA) and/or electronic data capture (EDC). When an EDC solution is implemented into a medical device trial, it provides immediate feedback, a high data quality, and more accessible trial information. It also facilitates an adaptive approach. In addition, it allows early termination for a trial that shows a negative trend, which helps reduce costs and reduce the risk to patients.
When a cloud-based solution is implemented, it improves the quality of data through discrepancy checks and automated edit, audit trails, faster data cleaning, and compliance with regulatory guidelines and good clinical practice.