The Broken Clinical Research System

Dr. Greg Koski of the Alliance for Clinical Research Excellence and Safety (ACRES) talks to Moe Alsumidaie of Applied Clinical Trials about the urgent need for change in the clinical research industry.

Moe Alsumidaie: Can you tell me about the challenges that are facing the clinical trials industry?Greg Koski: There are so many stakeholders working in the clinical trial enterprise, interacting, but often from within one silo to another. This gives the illusion of a unified system at work, but nothing could be farther from reality.

While there are a number of disciplined processes all developed by good people, there is limited interoperability and few well accepted industry-wide standards, even for critical processes. Additionally, the clinical trials endeavor is a very complex, competitive, and highly-regulated international environment. Many mission critical activities are conducted at study sites, but site performance is ‘challenged.’

This environment has created an ecosystem in which everyone is trying to preserve their own space and opportunities consequently, lacking transparency and collaboration. A shared space-a global clinical research collaborative network-could realize major benefits for all of the stakeholders. What we need is a comprehensive integrated system.

To address these challenges, ACRES, a not-for-profit collaborative operating in the public interest, is working to build a system that enables efficient and high-quality clinical trials for the betterment of the entire clinical research community and patients, something that is attainable through a global system but remains unrealized.

MA: Is clinical trial conduct ethical in its existing structure and model?GK: I believe that most individuals and companies engaged in drug development and clinical research are good, well-intended ethical people. Medical products are not the same as most consumer products, such as cars and electronics, since we must use human subjects, often patients, as a means to an end to test safety and effectiveness.

Some would say that this is in itself unethical, but it is part of the “grand bargain” with society-to get safe, new drugs, we must study people, but we are also obligated to do such studies in a safe, quality and efficient manner.

Without a unified set of standards and processes, without a deeply embedded safety or quality culture, and without an integrated global system to house the elements necessary to ensure the safe conduct of ethical trials, we are failing to fulfill our ethical obligations, and frankly, we have experienced too many ethical lapses over the years.

The industry’s part of the bargain is to discover new therapeutics to benefit patients, to improve their lives and productivity, and since we fundamentally use patients in clinical research to the betterment of this end, we have an ethical obligation to conduct safe and efficient clinical trials in a professional manner.

As a multi-stakeholder collaborative industry-wide, we need to gather these pieces together, determine what more needs to be created or modified, and then integrate them into a fully functioning, complex but interconnected whole to ensure a healthy research environment, and then we need to keep making it better!

MA:  Is the industry ready for change?GK: Ready or not, the industry must change, and it is changing dramatically. The industry is under enormous financial, regulatory, and ethical pressures, and the current approach does not support a sustainable enterprise. Suddenly, innovation and collaboration have become the by-words of the industry, and this newly found willingness to work together for change is very positive.