Clinical Trials in the People’s Economy

In classic economics, there is a law that states that there needs to be a certain amount of inputs in order to produce goods and services. These inputs include labor and capital, which in any economy are necessary ingredients to generate wealth and prosperity. Capital refers to the equipment and natural resources that are needed for production, while labor refers to the human workers (i.e. people). Even with all the shortcomings of classical economics, it can still be strongly argued that there will always be a need for people to interface with machines to produce things – whether it be a software engineer sitting in front of their computer, or a carpenter using a drill press, or even a medical technician using an MRI machine. In each of those situations, the need for both labor and capital is certain since the interaction between these two inputs are essential for performing their functions. In other words, a sewing machine will not autonomously stitch a shirt by itself without a seamstress. As with most things in reality, machines will break at some point and will need to be repaired or replaced. However, more often than not, it is preferable by the owners to discard and replace a broken machine instead of repairing it.

Courtesy of Karen Collins ©2015 Flat World Education, Inc.

Like machines, people can also break by becoming sick or injured, thus requiring “repair” through healthcare services. Unlike machines, people cannot simply be discarded and replaced like non-sentient assets. The human element is what comprises the whole economy and its livelihood. People create ideas, inventions, and products that benefit society. A machine can be reproduced, a person’s innovation cannot be. People also drive the economy through their demand for goods and services . So in essence, the economy is a social construct that depends heavily on the health and welfare of the people who make and buy things. Consequently, it is imperative that we focus on how to provide affordable and accessible “repair” services that are needed for “broken” people – hence, patient centered. Who would have thought altruism would benefit the materialistic economy?

Photo courtesy Universal Robots A/S

According to a study by Tufts Center for the Study of Drug Development (CSDD), the cost of developing a new prescription drug is about 2.5 billion dollars. This is more money than the value of the Los Angeles Dodgers baseball team, which is estimated to be $2.4 billion. And that is only for ONE drug. Given this astronomical cost and daunting complexity, clinical trials have the potential to be greatly enhanced through the comprehensive lenses of the systems approach.

Clinical trials – like any complex system in modern society – can be distorted through misaligned objectives stemming from societal fears that fail to consider the needs of technological innovators (i.e. pharmaceutical and biotech companies) and the struggles of users (i.e. patients). These distortions can be seen through a variety of scenarios. What happens to society when a patient who regularly performs duties that contribute to the economy is out of work due to a clinical trial that is prolonged and overly complicated? What happens to insurance companies and the premiums when pharmaceutical companies share their data with the public? Does the rigor of clinical trial regulatory practices benefit or hurt the global pharmaceutical market? These are questions that one must ask when they use a systems approach methodology. There is no single central question because we MUST transcend the narrow scope of ordinary scientific inquiry.

As an independent, ragtag team of researchers, architects, and engineers (think A-Team), we are in a unique position to ask these questions and stimulate a positive shift in the system, as well as rebuild this 2.5 billion dollar process.

Gary Lin