Improve Clinical Sites By Bringing Together Pharma, Biomedical R&D and CROs

By Ed Miseta, Chief Editor, Clinical Leader

As the co-founder, president, and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES), Greg Koski has a big job in front of him. How do you take pharma, and other biomedical R&D, as well as CROS, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public?

ACRES certainly has an ambitious agenda. The ACRES website [www.acresglobal.net] notes the group hopes to eliminate inefficiencies and waste from the clinical trials process, while building a culture of safety, ethical behavior and quality throughout the biomedical R&D industry. All stakeholders, including pharma and CROs, will have to be onboard with the effort. 

I spoke with Koski to get his vision of the end goal, how he plans to make it happen, and the individuals he is enlisting to conquer the challenges and make the vision a reality.   

Ed Miseta: In building ACRES, you have talked about bringing together experts from around the world to truly make this a global effort. What kind of folks are you attempting to bring together?

Greg Koski: I think the easiest way to get a feel for that is to simply look at the people who have already signed on as members of our executive office, advisory board, and board of directors. They are typical of the type of talent and passion we are bringing to this collaborative effort. ACRES is about building an alliance, and the way to make that happen—in addition to outreach such as this interview—is to reach out to members of one’s social networks. They will reach out to their contacts, and those folks then reach out to their contacts. Closing six degrees of separation, pretty soon you have everybody in the world involved!

I came to this effort with 40 years of experience in every aspect of human research, including science, ethics, patient advocacy, policy, administration, regulatory affairs, academia, and industry. In my roles, I was able to establish connections with people in all of these different areas around the world. We continue to tap into this extended network to develop ACRES.

Early on, I was joined by my two co-founders: Beat Widler, who was the former global head of quality management for Hoffmann-La Roche, and Andy Olmsted, who's the principal in Research Dataware, a company engaged in electronic networking and data flow.

We were later joined by Matt Whalen, our COO, who brings over 30 years of experience including organizational development and change efforts as well as corporate social responsibility to the table. Brian Edwards, from NDA Regulatory Science, has spent many years in the industry and is the former president of the International Society of Pharmacovigilance. He has brought key quality people to the table.

Still others on our leadership team are knowledgeable and respected figures in site management, clinical trials, quality, disruptive transformation, regulatory, clinical medicine, standards, cultural diversity and much more. All are likeminded visionaries who understand what systems are all about. They understand the need for doing this collaborative effort, both in financial and human terms. 

Indeed, a common trait among those most involved in ACRES – from our Board of Directors, Advisory Board, and Executive Office to our strategic allies – is that of being social entrepreneurs.

We now have more than 75 strategic allies, in-place or in negotiation, that bring thousands of people to the table from every sector of the endeavor. It's become a movement for systems thinking, for collaboration based in Accountable Research™, and we are very excited about the part we have played in it. 

Miseta: It seems, as one of its core components, ACRES is trying to serve the industry by creating a network of high performing sites that will have processes, standards, and procedures in place that we can all agree are necessary. This will bring sponsors and CROs a more finely tuned and efficient system of sites. Is that an accurate statement?

Koski: I think you've got the gist of it, but ACRES is not serving the “industry”—it is serving the entire endeavor.   Sites are one important element but they are just one component of a whole system of stakeholders and operational processes. I frequently compare it to the airline industry. Air transport is a highly competitive global industry, but it would be foolish for an individual airline to build its own network of airports. It makes much more sense to have a global network of airports that adhere to globally-recognized standards that can serve the needs of all. That improves the process for everybody, both in terms of safety as well as operational efficiency.

We are bringing the same philosophy to clinical research. Sites are one example. Currently, no one really even knows how many sites are out there, and a large number of those sites are here today, gone tomorrow. We want to create a sustainable network of high quality, high-performing professional sites that can be used advantageously by everyone.

Here is an example of the benefits: Today, if a sponsor like Pfizer were to do a large-scale Phase 3 trial, they might go to one or more CROs, each using a database of sites they have available to them. From that database they would try to identify sites that could possibly perform the trial.

Once they have identified possible sites, they have to go through a process of site selection and study initiation. It costs between €30,000 and €40,000 Euros to get each site up and running, and sadly, two-thirds of the sites selected using the best available processes currently available will end up enrolling only one or two patients. Ten percent of the sites will never enroll a single patient. And when it is time for another trial, the process is done all over again.  That is not a recipe for success. It's a model of waste and inefficiency.

By having a network of accredited sites, we can weed out those nonperforming sites and provide incentives for the others to become professional and sustainable. The goal is to recognize and reward excellence. When we do that, everybody wins. Sponsors and CROs understand that, and they have been increasingly supportive of the effort.

Miseta: Going back to your airline example, if one airport discovered a way of doing something better, it would make sense to share that information with other airports so everyone could benefit. The airlines, airports, and ultimately the passengers benefit when we do things more efficiently and cost effectively.

Koski: Absolutely! We may never figure out a way to get people on and off planes more efficiently, but consider another example.  Not all that long ago, baggage handling systems around the world were a disaster. As many as ten percent of bags were routinely lost or damaged. The airline industry, including airports and airline companies along with regulators and systems experts, formed an operations group with the goal of developing standards for baggage handling systems.

From that group came the standardized barcodes and airport codes that are used around the world. Conveyor belts are now a standard size to be able to accommodate travelers’ bags of all sizes. And there are optical tracking systems to ensure the boxes going to St. Louis will be automatically and accurately directed to the correct location. Standards were created for accreditation of baggage handling systems, and groups are in place that go to airports around the world and make sure the systems are going to work. Today these systems are interoperable and much more efficient. Of course, they are not perfect, but when a bag gets lost, we can now find out why it got lost, feed that information back into the system, and ultimately make the system better. That's what this is all about. We want to have that kind of system in place in the pharmaceutical industry as well.

Miseta: All of this looks good on paper, but pharma is a conservative industry that is not always anxious to embrace change. What do you believe are the biggest challenges you will need to overcome to make your vision a reality across the industry?

Koski: You already identified the first one. Whereas the airline industry started the creation of its global system some 70 years ago, the pharmaceutical industry has, over the last 50 or so years, created the current, more fragmented environment. Companies have made individual improvements by making investments in their internal systems. However, while those efforts can be useful, they lack interoperability, integration across the entire endeavor. We are now moving toward models of open innovation, sharing, and collaboration, and those are the key words in moving forward today.

We need to demonstrate to this industry, one that has spent years creating silos, the value in tearing down some of these silos. In some areas it just makes sense to do so, and in place of the silos we can create a shared infrastructure, just like we have in the airline industry.

Having said that, there will be problems to overcome, especially relating to messaging and credibility. However, I believe we may have current circumstances on our side. Many pharma companies are not in the same financial condition that they were just a few short years ago. With the time and cost of getting a new molecular entity to market increasing substantially, and a greater openness and willingness to embrace collaboration, there has never been a better time to undertake this effort. The key to this effort is getting sponsors and other stakeholders to recognize the value of a systems approach, and I think the need for that is very dramatic right now.

Analogously we are even seeing the President's Council of Advisors to Science and Technology issue reports saying systems engineering is the key to solving the problems we have in healthcare. We don't have a healthcare system, we have a healthcare mess. Systems engineering is the next generation thinking that will fix it.

Aside from that, we also have challenges in moving to a more global environment. Despite many years of efforts toward regulatory harmonization, we still don't have a climate in which we've been able to achieve standardization. As I frequently say, “harmonization has come to be a euphemism for failure to standardize.” If we can't get to standardization, we will never be able to do this. If we can have standards in plumbing, electrical codes, construction, information technology and, as Dr Freda Lewis-Hall has said, even for hair stylists, then we can have standards in pharma as well. We just need for all of the stakeholders to be flexible and willing to build the necessary interfaces to make these approaches possible.

Although there are challenges, the potential rewards are great. The clinical trials process is a $70 billion annual enterprise. Waste is conservatively estimated to be around 30 percent. So that’s $21 billion that is just squandered every year. If there are steps we can take to bring needed medicines to patients more efficiently and cost effectively, to not do so would be unethical.  And the positive impact for sponsors and their investors would be dramatic as well.

We live in a pretty small world, and we are all players in this. Working together is the only way we will be able to reach our goals.