In this article, we delve into six key clinical data management practices for the complex terrain of biotechnology trials. From setting clear study objectives to embracing risk-based quality management, these practices underscore the industry's commitment to precision, efficiency, and innovation as it propels itself into the future. These practices are driven but evolving technologies that are helping to shape the clinical data management stage of drug development.
An industry that was once fully paper based has slowly transitioned to accommodate and implement the advances of technology. This has resulted in increasing availability and size of d
Due to the advancements incorporating technologies into clinical data management best practices the conduct of trials has improved with more efficient trial designs, enhanced patient monitoring and optimized data collection and analysis.
Technology has also enabled more efficient recruitment of participants, shortened timelines and reduced trial costs. Technology has become an increasingly important component of clinical trials and it's expected to continue to revolutionize the field of biotechnology in the years to come.
The transformation in the industry started with the introduction of electronic data capturing (EDC) systems. Data acquisition and analysis has since become more sophisticated and integrated with various digital technologies now available for usage in trials. This has also enabled more efficient recruitment of participants, shortened timelines and reduced costs. As a result, technology has become an increasingly important component of clinical trials and it's expected to continue to revolutionize the field of biotechnology in the years to come.
Let’s look at how a CDM department may be set up in a biotech company and the best practices they would put in place. Due to different company structures and characteristics a biotechnology company is likely to have its own unique characteristics that will influence it’s department governance and set up compared to other types of drug developers like large pharma.
Biotechnology trials are usually conducted for longer periods of time and therefore generates a substantially large amount of data. A higher level of expertise and data management is required because there is a need for a more systematic and structured approach to data collection, processing and analysis to avoid study delays and budgetary issues.
Biotechnology companies source funding for their research and development from external investors. Clear objectives for the project, including the expected outcomes and timelines should be agreed on by the sites, CRO’s and sponsor prior to study start up to avoid unforeseen delays, issues in data quality or unexpected increases in the study budget, which may result in investors withdrawing their funding. Timelines should be as realistic and detailed as possible, always include a few additional days on each task which could then be utilized for unexpected delays during start up i.e., it’s better to have worst case scenario timelines.
It is important to establish a centralized Clinical Data Management system (CDMS), specifically for biotech studies where the volume of data is larger with multiple data sources/vendors. This approach reduces duplication of data and errors that arise from the use of disparate data sources i.e., Data collected for participant randomisation and Patient Reported Outcome Assessments should be integrated and stored in the same EDC system.
Centralized CDMS also ensures that data are consistent and standardised across the study. This approach promotes data sharing, facilitates prompt decision-making and enhances the accuracy and completeness of the data collected.
As there are multiple EDC systems to choose from, it is important to choose a system that’s best suited to the study design, budget and project requirements. EDC is a computerized system that enables researchers to collect and manage study data remotely. The EDC system eliminates the need for manual data entry, which can be time-consuming and prone to errors. EDC also allows for timely data corrections, reduces the potential for missing data and improves data quality.
Most biotech trials require integrated solutions such as randomised trial specification management (RTSM), e-PRO (Participant questionnaires and diary card data) and Target Source Data Verification (TSDV) which aids a study where a risk-based monitoring approach is required.
Biotechnology trials involve the use of various technologies, including genetic engineering, molecular biology and genomics to develop and test new treatments for a range of diseases and illnesses. In these trials, we tend to see larger amounts of data being generated and collected from various sources, including participant medical histories, laboratory test results, and clinical assessments.
An effective data integration and handling process is essential for successful trial management and to ensure accurate and reliable results. The first step to ensuring good management and oversight of data handling is the creation of data handling plans and data flows specific to each data source/vendor from which the data will be transferred/integrated and reconciled.
Data integration involves combining data from multiple sources and platforms to create a comprehensive dataset that can be analysed and interpreted. Data handling procedures must adhere to strict quality standards and regulatory requirements to ensure the integrity of the data throughout the trial. This involves the use of rigorous quality control processes, efficient data entry and ongoing monitoring of data quality. The frequent reconciliation of data coming from external sources is vital in adhering to these standards and achieving high quality data.
It is encouraged to establish a comprehensive training program during study start up for all stakeholders involved in the clinical data management process. A robust training program ensures that all stakeholder staff members are familiar with the data management plan, the database design, the use of technological solutions and regulatory standards. Such training enables personnel to perform their roles effectively and helps prevent errors and delays arising from the incorrect use of data management systems. It aids in decreasing the number of queries raised during study conduct by Clinical Research Associates (Monitors) and CDM.
Due to the complexity of biotech trials, it is vital to have clear standards and guidelines in place for the data collection process. This can ensure consistency and accuracy in data collection. Successful data management requires communication and collaboration among team members, stakeholders, and regulatory authorities. Project and Data Management plans should detail the procedures and standards for overall study and data management between all stakeholders involved with collecting, processing and analysing the clinical trial data. It is important to specify who is responsible for data monitoring and management and define the roles and responsibilities of all stakeholders. Establishing clear plans ensures that there is consistency and understanding in how the data is collected, processed and monitored by all stakeholders.
A Data Quality Management plan is an approach used which is aimed at enhancing clinical trial data quality by focusing resources and effort on areas where potential risks to the trial are the greatest and whether interim data quality reviews would need to be conducted. This RBQM (Risk-Based Quality Management) system involves evaluating and managing risks proactively throughout the trial, rather than simply detecting and addressing issues after they arise. In the context of biotechnology trials, RBQM can help identify and mitigate risks related to the complex nature of the therapies being developed, as well as the high cost and time constraints associated with these trials. It helps to ensure that trials adhere to regulatory requirements and standards, while also allowing for flexibility and innovation in trial design and execution. It is an important strategy for improving the efficiency, safety and success of trials.
Adhering to these practices and processes in clinical data management for biotechnology trials is vital due to the large amount of patient data and the potential of multiple data collection sources. The key factors mentioned above will optimise the entire process, enhance quality, efficiency and cost-effectiveness, therefore ensuring compliance with regulatory standards and improve the trials potential success. Implementing this approach with advanced technological systems and comprehensive training programs can significantly improve the accuracy, reliability, and integrity of the data generated during clinical trials in biotechnology.