Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
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News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
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Innovation in clinical research is happening all around us, and while at the SCOPE Summit in Miami, I had the opportunity to interview Dr. Greg Koski about the Alliance for Clinical Research Excellence and Safety (ACRES).
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 construct a global system for clinical research by creating a “home” for collaboration and by serving as an incubator for innovation needed to build this integrated global system for clinical research that currently does not exist. We are doing this by developing implementation-driven initiatives with key collaborators to share and leverage their experiences and expertise through a best-in-breed, continuous improvement approach to collaboratively design an inclusive, workable global system. ACRES is not in the game to make money—ACRES goal is quite simple: 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.
A ‘Systems Approach’, done well, fundamentally aligns good ethical principles with good business and scientific practices—essentially quality by design. A successfully designed and implemented system, one based in the efforts and needs of all stakeholders in the clinical research endeavor, is also one that improves quality and performance. Many of the components of such a system already exist, such as CDISC standards, which have been proven to improve efficiency and quality. Now, 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! We need “next generation” thinking and innovation, something in which ACRES many allies are actively engaged and to which they are strongly committed.
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. ACRES recognizes that effective investments must add value, and understands that failure to leverage them and maximize their value is a tragedy—which is what happens when investments are undertaken in isolation. The alliance model is a way to avoid such fragmentation, to allow for collaboration while also maintaining a competitive edge based in excellence. ACRES, as a neutral party, unaffiliated with any one group, such as sites, CROs, regulators or sponsors, is facilitating collaborative development of a system that will benefit all stakeholders. That is, a system that will improve safety, efficiency, and quality in clinical research for all the right reasons.