As clinical trials have resumed in earnest following the pandemic’s stranglehold, the reinvigorated focus on different methods by which to conduct trials have opened up new avenues for innovations and longer-term benefits for sponsor companies.

Shorter drug launches?

Newer patient-centric modalities, adaptive and greater-complexity clinical trials, and other innovations in this space can lead to drug launches occurring over potentially shorter timelines (maybe up to 1-2 years shorter, at their optima). They can also lead to cost savings within the clinical drug supply chain, but usually only after infrastructural changes are in-place and paid for. McKinsey has estimated these supply cost savings at 15-20%, which if you consider the overall cost structure of clinical trials, is an enormous amount of money; equating to an additional “free” clinical trial after every 5-7 of them run.

COVID-19 pandemicity’s effect on clinical trials has been to drive many of them to decentralized models, which isn’t really a bad thing, and may in fact have required that as a burning platform in order to actually move in large-scale toward that direction so quickly.

Be like Toyota

The best companies at clinical supply challenges at the moment are those who are embracing the practices of lean manufacturing, developed at the Toyota Production System. The idea, broadly, is to attack waste in all of its forms in order to optimize the total value of the supply chain and value stream.

The most comprehensive data which exist across verticals (McKinsey & Co.) shows that 19% of the packaged and labeled clinical kits had deviations (about 1 in 5(!)), of which 7% resulted in complaints. The waste from Investigational Medicinal Product (IMP) kits was ~50% in this analysis, “primarily due to poor forecasting and planning.” Improving this could yield “annual savings of more than $100 million by improving waste performance to best in class.”

Clinical leaders’ confidence matches consumer confidence

We’re in a challenging time on the global stage with inflation concerns, commodity pricing issues, and other economic headwinds of great magnitude. Fewer than half (this means below 50%, by the way, for those keeping score) of clinical drug supply managers surveyed were confident in their ability to provide adequate supply for clinical trials. This correlates strongly with consumer confidence at the moment, which is hovering at about 107 points (see Figure 1).

In the world of microeconomics and macroeconomics, variables do not operate within a vacuum divorced from effects and pressures from other variables. We need to be cognizant of these external market pressures when making accurate forecasting models for clinical trial designs and supply. Confidence in demand planning, by the way, is hovering at about 31%. Given these supply-side pressures, also take into account that Cell and Gene Therapies (CGTs) are on-track to more than double the representative proportion of drug launches in the next 4 years (from ~16% to ~36% forecast), and all of the above issues will impinge upon their trial statuses and success probabilities.

Buzzworthy trends

If you’re not continuously progressing, then you’re falling behind. Some of the most novel and noteworthy trends taking shape include:

• Enterprise resource planning (ERP) innovations to improve the supply process;
• Telehealth in trials to improve the investigational experience for more patients;
• Interactive Response Technology (IRT) to more seamlessly integrate patient data;
• Reduction in wastes/process redesign/deviation reduction;
• More real-time monitoring of trials, done more real-time; and
• Use of consultants, experts and CxO companies to leverage partnership excellence.

As we continuously progress into the future, any or all of the above trends will continue to shape trials, their successful outcomes, and they’ll eventually differentiate-out into a mix of approaches which, from the future’s perspective, should have seemed obvious to us now.

Resolving clinical trial supply challenges

What is clear, however, is that the global approach to trials, supply of trials, and oversight of trials is markedly different now, and represents a step-change to how we’ve done them over the past several decades. This is not such a bad thing; we just need to ensure that we continuously adjust our understanding and expectations to make sure the Sponsor:trial:patient:regulator interfaces continue to be robust, and ensure protection of human subjects while promoting safety and efficacy of the drug products that are under investigation.

All of the challenges that exist within the supply of trials can be effectively solved and managed, it just takes effort to understand each individual problematic output in the process itself, the causal factors involved and development of effective countermeasures to improve the resultant outputs. The patients end up benefiting on a massive scale, and the Sponsor organizations similarly stand to benefit in both velocity of successful trial outcomes as well as financially from reductions in loss and waste. As the saying goes, “Companies that do good, do well.” Be those companies. 

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Ben Locwin
Contributing Editor

Dr. Ben Locwin is a healthcare executive and a professor of healthcare economics; He has worked on the development of adaptive clinical trials, decentralized trial designs, and synthetic control arms for clinical studies. Much of this work is designed to bring better medicines, faster, to patients in dire need who otherwise wouldn’t have access to them. He has been featured in The Wall Street Journal, Forbes, USA Today, The Associated Press, and other top-tier media outlets.