If you’ve worked in Clinical Operations, you’ve probably sensed when things are inefficient. Signs include:
- Spending 30 minutes daily just searching for documents or information
- Toggling from system to system or spreadsheet to spreadsheet
- Checking someone’s work to the point of essentially redoing it
- Forgetting the outcome of key decisions, their rationales, or where they’re documented
- Numerous meetings with unclear objectives or outcomes
Efficiency is defined as: performing or functioning in the best possible manner with the least waste of time and effort.
The scenarios above all waste time. And in the busy, fast paced world of Clin Ops, wasted time is costly.
Wasted time leads to poor trial and team outcomes:
- More work in less time, which can lead to employee stress and burnout
- To help current employees, teams usually end up hiring more people and throwing them into an existing inefficient structure. This ends up adding complexity and requiring more coordination between people.
- Critical activities not being done at all, leading to slow site selection/activation, low recruitment, poorly thought out EDC and IXRS systems, and rushed inspection readiness.
- These add to the inefficiency, and create additional workflows of redoing work or fixing mistakes that might never have happened with proper planning. These extra steps are likely to lengthen the study timeline.
This brings us to the crux of our post: hiring more people and increasing the study timeline have big financial consequences.
An analysis done by the NIH in 2018 showed that 22% of phase 3 studies failed to complete due to lack of funding (despite having a potentially viable drug).
Another study done by the HHS cites:
Closely related to the cost of clinical trials is the length of time it takes to complete them, which has also increased in recent years. Lengthy timelines [also] directly contribute to lower revenues over the course of a drug’s lifecycle, increasing the financial burden of drug development. For instance, long trials mean large human labor costs, as investigators and staff must be compensated for many hours. Long development times also reduce the time a drug has under patent protection, thereby opening the door for generic competitors and reducing the amount of revenue that can be earned. Additionally, the potential for study results to impact medical practice may be reduced over time as changes in clinical practice or the standard of care might make the new drug obsolete.
We hope the industry moves away from large, unwieldy teams that spend hours on complicated, manual processes. Instead, let’s cultivate lean teams that are efficiently supported by thoughtful technology to focus on work that directly affects trial timelines.
Sources
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/
- https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development
