In the pharmaceutical industry, costs are becoming an increasingly scrutinized component of the clinical development process. Companies are looking to increase profits by getting drugs to market faster. They are trying to bolster margins by conducting trials with the fewer and fewer resources. Along these lines, many clinical operations groups are collecting clinical trial metrics as fast as they can to get their bearings and improve performance.
However, most groups do not have a true understanding of the “why” behind the clinical study metrics. As a result, they end up collecting far too much data. They misapply or misinterpret the resulting information – when they aren’t too busy drowning in their own data. It is clear that an R&D organization’s approach to metrics shouldn’t differ from that of any other department, or any other industry.
In fact, you can learn many valuable lessons by reviewing cases where the use of metrics in other industries went horribly wrong. By analyzing from the top down why metrics are important and how to use them to maximize the impact on a company’s bottom line, clinical operations and other groups within the industry can save much time and effort. They can make a difference where it counts – in the company’s bank account.
Clinical Operations – Metrics That Matter
In his book “Pharmaceutical Metrics: Measuring and Improving R&D Performance”, David Zuckerman discusses his three principles of measurement. Metrics:
- Measure progress toward our goals
- Help us prevent failure
- Get us out of ruts
These principles describe, on a strategic level, why metrics exist in an R&D environment. Before we get to this tactical level, an understanding of the more strategic needs behind the use of metrics needs to be in place. The first question to ask is, “Why do we need to collect metrics to begin with?” The answer to that question is not rooted at the departmental level or even the divisional level. It is embedded at the corporate level.
The overwhelming majority of biopharma companies are publicly traded (or wish to be). Hence it follows that, like any company, they share the goal of serving shareholders first.
One issue that clouds this straightforward proposition is the nature of the industry itself. Many who work in the industry- particularly those who jobs are tied to clinical research – view the idea of having monetary profit as the primary goal of their company as distasteful. It runs contrary to the more idealistic notion of helping their fellow man. As a result, they justify process improvement efforts (and related metrics) not by the support of solid business cases but by qualifications such as “this will make our lives easier”.
There is a problem with this approach. Even if everyone can agree that they will make their lives easier, no one seems to know if the company will actually benefit financially. Helping people and benefitting monetarily are not mutually exclusive ideas. Just because the company makes money, it doesn’t lessen the benevolent intentions.