Clinical studies are complex, so involving biostatisticians early in the product development has major benefits for the quality of data collected and how it can be used.
The main goal of any clinical study is to make the best-informed decision based on clinical data gathered and sophisticated biostatistical analyses. In too many cases there are far too many data points gathered. As biostatistics teams are the ones who handle this vast data, their guidance is crucial at all stages of product development planning.
There are a variety of benefits to involving a biostatistics team in these early stages. For example, Phase II dose-finding trials are essential to establishing an optimal dose that will maximize efficacy whilst minimizing safety concerns. Therefore, inadequate dose selection at this stage is a major driver of development failure. Utilizing a biostatistician will contribute to achieving the goal of an optimal dose by using advanced, well-established, and regulatory-acceptable statistical methods for dose-finding.
As the cost and timing of studies are enormously affected by their actual needed size, biostatisticians can also offer insights into which parameters to measure and the required number of patients to recruit. They can also advise on how to streamline the process by assessing exploratory endpoints in early phases that might be useful in future studies and ensuring the eCRF is set up to capture data in the correct way.
Another way that the clinical study process can be streamlined is by maintaining the same biostatistics team throughout. This is a key cost and time saver for any product, especially when the statistical analysis plan can be written by the same biostatistical team who wrote the protocol.
Equally importantly, in order to effectively use the gathered data, it is vital that it is of high quality. Involving the team in data quality control can help to ensure this, as it allows data management, collection and entry errors to be noted and corrected throughout the study, rather than retrospectively fixed once the database is locked.
At LINK Medical, our biostatistics team includes professionals with expertise in biostatistics, programming and senior advisors with knowledge of regulatory requirements, giving our clients the broadest possible knowledge base. In addition, our long and proven track record and deep understanding of Viedoc™, our preferred EDC, elevates the level of quality and effectiveness in data collection. Contact us to talk about how we can provide the resources required to support the clinical development process before, during and after clinical studies.