Clinical trials are horrible things. Although biopharma is led by scientific endeavor and only has patient safety and therapeutic benefits in mind, the process of bringing drugs to market is long, complex, bureaucratic, and above all else, expensive.
The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials. It is a bottleneck at the outset that slows drug development.
Think about it in these terms: add one day to the duration of a clinical trial, and it costs $1 million. Lose a day from your market exclusivity due to a delay in submission, and it could cost you $8 million. According to Cutting Edge Information 72% of studies run more than one month behind schedule. Given these facts, it’s clear that the ‘status quo’ is not good enough. Reducing the time it takes to launch a study is critical to increasing the bottom line.
Where are the bottlenecks? It’s an obvious question to ask, but unfortunately, the tools traditionally used to conduct clinical trials lack robust reporting capabilities. Business intelligence (BI) has become an increasingly popular topic in clinical trials. Clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data. Sponsors and contract research organizations (CROs) are looking for ways to incorporate BI into the eClinical systems that they are already using to empower oversight to turn raw trial data into actionable information. As Aldous Huxley, a renowned English writer and philosopher said, “Facts do not cease to exist because they are ignored.”
BI initiatives continue to top sponsor and CRO priorities, as executives demand greater visibility into trial data at a much faster pace. Manually prepared data is often too old to represent a reliable status, and readily proving a study is on track can be an ongoing challenge. Instead of one-dimensional, static reports, sponsors and CROs need interactive, real-time answers about study startup statuses.
According to Linda Sullivan, Co-Founder and President of Metrics Champion Consortium (MCC), “Benchmarks should be generated from standardized, well-conceived, data elements and performance metrics. Additionally, the data needs to have sufficient metadata associated with it so you can make meaningful comparisons and correlate benchmark results with best practice outcomes.”
For a long time, Sullivan has been encouraging stakeholders to engage in the process of risk assessment from the start, instead of relegating it to a costly afterthought. For clinical trials, this translates into proactive, proper planning and risk mitigation by determining what needs to be measured and when to take appropriate action. Performance metrics are critical tools in aiding this process.
Every industry has its own way to express metrics and key program indicators (KPIs). The study startup phase of clinical trials is no exception (e.g., document and submission status, milestone status, task duration, etc.). Traditional eClinical systems have fallen short on delivering rapid analytics and insights. While these platforms have perfected scheduled, parameterized reports, they do not do what they now espouse. They do not provide self-service BI—such as, powerful visualizations that empower business decisions, customizable reports, drag and drop visualizations, and interactive dashboards—allowing decision makers to make faster, better decisions that improve performance and directly impact their clinical study startup conduct. But that’s changing. Oracle Health Sciences goBalto Analyze Cloud Service provides true BI dramatically delivering relevant insights with visual reporting, enabling clinical research teams to visually analyze their data in a way that makes sense for their purposes.
goBalto Analyze helps sponsors and CROs see and understand data, empowering oversight and casting light on bottlenecks by allowing them to analyze, visualize and share information quickly. As John Tukey, American mathematician, said, “The greatest value of a picture is when it forces us to notice what we never expected to see.”
The upshot? True BI is the ability to proactively identify and resolve bottlenecks in real-time, instantly view statuses, quantify your team’s performance, and discover meaningful patterns in your clinical study startup data. Today’s industry leaders in clinical trials recognize that good data increasingly translates into a competitive advantage.
Interested in learning more about clinical trial BI intelligence visualizations? Contact us.