The most important element of all clinical trials is data as it supports the efficacy of the drug, and is required for regulatory approval and to ensure safety. Faulty data will most certainly lead to bad results, bad products and a loss of revenue. With drug development costs reaching over US$1 billion per product, biopharmaceutical companies need to ensure excellent outcomes for clinical studies.
No single approach is appropriate or necessary for every clinical trial. However, advances in technology are allowing sponsors to employ strategic thinking and practices from the start to mitigate risk, such as a greater reliance on centralized data. This refers to the practice of gathering and referring all the data from a single place, which allows information to be easily integrated and visualized. This model is encouraged by the US Food and Drug Administration (FDA).
The main benefit of centralized data is that it improves the ability to ensure the quality and integrity of the data and study, which results in efficient data analysis. This is because it allows drug makers to review and update data in real time and to take action on issues faster than before. As such, centralized data results in significant cost reduction and excellent time management.
According to biopharmaceutical experts, other benefits of centralized data include:
- Prevention of redundancy and assurance of consistency across all clinical and regulatory documentation
- Faster identification of missing, inconsistent or incomplete data, as well as errors in data collection and reporting, such as statistical biases and treatment imbalances and even fraud
- Facilitation of updates to regulatory authorities
- Consistency in communications and reporting by using common evaluation methods
- Optimization of on-site visits by keeping track of site performance and communicating any issues across the team involved in clinical trials
- Provision of better insight on quality and safety trends, which will support quicker team or management decisions
On the contrary, when sponsors do not have their data centralized they face difficulty analyzing information, a lack of traceability of crucial information and slow resolution of regulatory demands.
As well as the centralization of data in clinical trials, people in the industry believe it is helpful to standardize data. This means that data from many studies should be collected, integrated and analyzed in a standardized format from the start to allow sponsors and regulators to find information faster and more effectively, and to facilitate data exchange between providers and partners.
Centralized data involves preparation, as well as changes in management and processes. Despite the benefits of technology, sponsors need to hire people who are experts at detecting risk and identifying problems, as well as solving them in real time. The complexities have, in some cases, led to only a few sponsors implementing the model of centralized data. Some experts even think that this model is unlikely to be adopted due to multiple interests and sensitivities within companies; however, the general consensus is that centralized data, where appropriate, is a smarter, more efficient and cost-effective way to ensure quality and safety in clinical trials.