How Time, Quality, & Cost Metrics Affect Clinical Trials and Programs
Colin G. Miller
There are principally three characteristics or metrics, we can use to measure any major process: time, quality, and cost.
The challenge is that these three are in competition. Nowhere is this more apparent than in the design and implementation of clinical trials and clinical programs. There are three characteristics but you can only emphasize two!
In the current environment, we have seen COST become the main driver throughout the pharmaceutical and biotech industry. However, this usually works at the long-term penalty of quality and or time. A recent case in point was a small company that asked us to handle the imaging portion of the clinical trial. Everything was pared down to yield the most apparent “cost-effective solution” at the outset. We are now halfway through the trial and key imaging endpoints need to be delivered and safety evaluations are being considered. Suddenly the need for quality has come to the forefront, particularly as the data will be going to a regulatory agency.
However, this shift has caused increases in the scope of work that may exceed the original budget and possibly be higher than necessary due to the amount of rework, which would have been negated if the need for quality had been more carefully considered at the start. Furthermore, time is of the essence, but due to prior decisions, it has to take second place behind the quality issues.
Not to be outdone, the familiar big pharma code words “looking at the most cost-effective solutions” really means “drastically reducing our internal budgets and vendor budgets for the same level of work”. It will be interesting to see if this strategy will truly produce more products brought to market cost-effectively or whether quality and time effects will eventually show through in this highly regulated world.
In a different arena – cars manufacturing – we have seen this play out to a dramatic effect with Toyota. For many years Toyota has built a reputation for quality and reliability. “Everyone knew” that a Toyota would last for years. Then Toyota shifted from its primary metric and elected to become the Number One car manufacturer in the world. Cost and time took priority over quality, and long term, we now all know the results.
The pharmaceutical industry lives in a far more regulated world, so I have less concern about the potential “Toyota effect” – since the FDA and other regulatory bodies help ensure that safety and quality are paramount. However, drug development will take even longer if the quality is not maintained. Innovative technology solutions will not be developed nor implemented any sooner under a “keep cost low” mantra.
The industry desperately needs to reduce the cost of drug development, but rather than just slash budgets, identification of high impact new technologies should be evaluated. If implemented correctly, higher quality systems can be implemented which over the long term should result in cost savings and efficiency. This only works if the principal metrics are kept in balance.
I have recently heard it stated by a consultant at a pharma company that “we are going to cut budgets by 10% each year while increasing output” With that metric at the forefront, we will all do more and more for less and less until we can do everything for practically nothing!