Conducting clinical trials is becoming an increasingly expensive process, fraught with operational challenges and inefficiencies, and given the pressure on budgets and resources, biopharmaceutical companies are continually looking for innovative solutions to improve their outcomes. Over the past few years, a rise in newly available technologies and an increasing move towards electronic processes such as eTMF, eConsent, etc has opened new ways of overcoming some of the existing inefficiencies in clinical trials.
This increasing focus on going electronic and including new technologies in clinical trials mean that modern trials amass a huge amount of data from a variety of sources. While this data has almost unlimited potential to be leveraged to gain unique insights into how clinical trial operations can be improved, many biopharmaceutical companies struggle to analyse the plethora of data they have at their fingertips. The reasons for this are manifold and differ depending on the company’s size and resources.
But for many organisations, the first challenge they come up against in trying to make use of this data is how to aggregate different sources into one cohesive database. Some would say that the clinical trial industry’s risk aversion is a key culprit in why it is slow to embrace innovation that could improve efficiency in trials and improve their overall outcomes. Another challenge, particularly for small companies with limited resources, is finding the budget to incorporate data and analytics software into their clinical trials. At the moment, the data gained from a clinical trial is utilized no more than once by the trial sponsor and is not leveraged to impact strategic decision-making on future trials. This represents a huge loss of potential insight into how clinical operations can be improved for particular trial sponsors and perhaps even the industry as a whole.
For those clinical operations professionals without substantial data backgrounds who do find themselves ready to take the step of finding an analytics partner to work with, they often struggle to cut through the technical jargon to understand the real benefits that particular software can bring to their day-to-day work. As data analytics models become more mature, the perception is that they also become more difficult to understand.
By implementing analytics software into your clinical programs, a number of key metrics can be analyzed including cycle time, enrolment, monitoring and cost. These metrics can be analyzed across the portfolio, program, study and site levels to quickly identify issues or to enable clinical trial leaders to make data-driven decisions. The benefits of such capabilities are multifaceted. By having aggregated data at your fingertips, it can improve alignment and accountability across departments, act as a progress measure, reduce timelines and allow you to make specific adjustments to your trials to improve efficiency.
Depending on the analytics platform, there are a number of ways insight can be translated into action. Advanced analytics capabilities may include real-time and predictive capabilities. Some platforms even have self-learning systems that are designed to improve predictions over time and allow past data to be leveraged to improve the operational efficiency of later trials.
As with any new technology, it has some potential limitations or pitfalls. How can biopharmaceutical companies be certain that they will receive a return on investment on the incorporate of analytics software?
The software opens up so many new methods to measure performance, it is important that trial sponsors carefully decide which metrics to measure so they have a consistent view of their performance and how to improve it. By choosing metrics that measure efficiency at every stage of the clinical trial process, clinical trial leaders can identify performance gaps and take steps to improve them.
To make the most of any new technology, it is imperative that it can be easily accessed and interpreted by everyone in the organization. Technology should be used to make employees’ lives easier and allow them to perform their job more efficiently. Therefore, a good training program is a must and will ensure that employees can easily access the data they need when they need it. By making sure everyone in the organization is on board with these new capabilities, you can leverage analytics platforms to gain real business value.
The utilization of analytics software to improve operations in clinical trials is still fairly new to the industry. However, it is already clear that harnessing this technology could revolutionize how trials are conducted and lead to vastly improved outcomes.