October 29, 2013 The idea came to Greg Koski while sitting in an airplane. “The entire world has come to recognize that the process that we've evolved for trying to get a new medical product—whether it's a drug, a device, or biologic—actually properly tested and reviewed, marketed, is fraught with enormous problems,” Koski says, “not the least of which, is the enormous inefficiency, redundancy in the process.” 

 

Koski knows a bit about the process. He served as Director of Human Research Affairs at Massachusetts General Hospital and the Partners Healthcare System in Boston. He left New England to go to Washington and set up the Office for Human Research Protections, where he began introducing systems thinking into the realm of human research, and worked with National Cancer Institute to build systems for clinical research. 

 

But it was at an airport that he realized that other industries have tackled logistical challenges before—and maybe the clinical trials industry had something to learn. 

 

With the goal of “tapping into the expertise, the wisdom of this multi-stakeholder community” Koski and his team launched ACRES: The Alliance for Clinical Research Excellence and Safety. ACRES hopes to combine strategic technologies to build an open, global system for clinical research. 

 

One of their first technology partners is ViS (see, Insightful Site Selection: Tools of the Trade). “We are proud to support ACRES. The ACRES network will enable sites to share their capabilities and efficiently communicate with sponsors and international peers,” said ViS CEO, Fabio Thiers. “It provides the foundation for a more efficient and sustainable clinical research enterprise, resulting in faster patient access to better and safer medical treatments.” 

 

Clinical Informatics News editor Allison Proffitt chatted with Koski on the idea behind ACRES, what has been accomplished since the network’s launch, and what he hopes to see next. 

 

Greg Koski: For about ten years I have been writing about and talking about the need to properly align good ethical principles with good business practices in order to basically have this entire industry and the process of clinical research remember what it's really there for, which is to bring new products to the people of the world in order to improve health, productivity and quality of life. We seem to have lost that sense of direction and it's time to be restored. 

 

If we can redesign—truly innovate—the way we've been doing things and effectively apply systems thinking to these processes, we can achieve enormous gains in safety, efficiency and quality in a way that actually benefits not only the people of the world but also the companies that are doing these things, their shareholders and everyone else.

 

And so, about a year and a half ago, after writing and talking about this kind of stuff for a long time, with the encouragement from a number of people in the industry, academia, regulatory affairs, the ethics community, we launched a non-profit organization called the Alliance for Clinical Research Excellence and Safety, ACRES for short. And the goal of ACRES is to achieve these kinds of integrated improvements and efficiencies through systems thinking, while being driven by the desire to do clinical research in a much more effective way that aligns ethical principles with the business practice. 

 

Koski: I was actually flying into San Diego [to speak at a BIO] meeting and as we were landing in San Diego, I was still thinking about the remarks that I would be making at this meeting. And as we were landing in San Diego, I looked out the window and I saw all of these planes lined up in the pattern in order to land. And San Diego's a tricky airport to land in because you have to come in over the mountains and drop down into the city and try not to go into the ocean. And I said, “Isn't that remarkable that you have all of these planes coming in from all over the world, they're all speaking the same language, they all know how to use the air traffic control system, the ground control systems, and the baggage systems to work together.” I said, "What if we apply that same kind of thinking to the clinical trials process?"

 

We set out to basically build a global system for clinical research that in many ways is inspired by the global air transportation system. More than half a century ago the airlines realized that they couldn't run a global endeavor like air transportation without actually having a truly global system with appropriate standards that ensured interoperability, appropriate safety and so on. 

 

We said, "Look, if they can do that for an airline, for an industry that's as complex and competitive as the airlines, what would happen if we tried to do this for clinical research?" 

 

If we think about a global system for clinical research, it basically translates into not a collection of internationally-accredited airports around the world but an entire network of accredited clinical research sites around the world, all of which are connected through a shared 

information technology infrastructure that is designed to use standards to acquire information at the source from the ongoing processes at each of these sites and to acquire and aggregate that information effectively in an appropriately-secured data warehouse so that, again, with appropriate protections for privacy, for proprietary information and so on, that those data can be actually analyzed for a variety of purposes. The benefits are absolutely enormous. 

 

Koski: We're about a year and a half into a process of actually building this global system. And at the core of that is what we call the ACRES Global Network, which is this amalgamation or alliance of clinical research sites all of which are committed to safety, to excellence in their performance, and quality in all of the data that they produce. They should be properly interconnected so that the information that is derived from the process will not only be the data that support the actual clinical trials themselves but data that can help to improve operations, to improve safety, and to drive integration and simplification in such processes as monitoring, regulatory oversight and so on. 

 

Our hope is to be able to register an initial group of 10,000 affiliated sites by the end of the year so that we can engage those sites in the several processes that we have underway, what we call our foundation initiatives, to build the additional components of the network so that in a sense the initial 10,000 sites would be a group of beta test sites where we can use this interface to reach out to them to get their feedback on things such as the development of the site accreditation standards that we're working on, get their feedback, evaluation of new pieces of the information technology platform as they are developed and rolled out, as well as, again, an avenue to be able to provide additional goods and services to support them. Ultimately, if we were as successful as the airlines, if we were able to have, say, 80% of all of the sites globally that are committed to safety, quality and excellence in performance as part of this network, that network could be used by all of the pharmaceutical companies, device companies, biotech companies, as well as academic institutions, public health entities and all to do research in a very efficient and safe way all over the world. 

 

Koski: The interface that we rolled out last week was developed through a collaboration with ViS and another organization called HealthCarePoint, HCP. They are only two of several organizations that we have been in discussions with as part of an effort to use a consortium of development models, a best-of-breed approach that takes existing technologies that are already established, like ViS and HCP. Three other IT collaborators have recently joined as well: ii4sm, Research Dataware and Forte Research Systems. 

 

Two other organizations that are allies with ACRES are CDISC and SAFE-Biopharma. CDISC, of course, has been around for more than a decade. They're the world's leader in developing standards for the acquisition and interchange of clinical trials data. CDISC standards are used globally and we believe that ACRES will provide an opportunity to have even further acceptance and application of those standards. 

 

We're working to also incorporate the SAFE-Biopharma Association standards for secure information exchange. It's currently the system that supports most of the exchanges of data among all the big pharmaceutical companies. We believe that using those standards and the technologies that support them, such as digital certificates that can provide not only secure transfer of information, but also non-repudiation and other capabilities that are essential, this will be an extremely valuable contribution to the entire process as a whole. 

 

Our goal at ACRES is to basically be a catalyst and an implementation engine for achieving these enhancements in safety, quality and efficiency that are not only possible but are fully anticipated from this global systems approach. 

 

Koski: Even with this very, very early phase rollout of the demographic information system that ViS has developed that allows their information to be shared with sponsors who are doing feasibility studies to identify sites where they will be able to conduct studies in a quality and efficient way. At the same time, sites that register with ACRES are provided with an HR management package through the HealthCarePoint, through a system they call the PET-ABC HR Management system. 

 

At a very simple level if a company were going to do a trial it would need to ensure that each of the investigators, members of the research teams had certification of their training in GCP. The PET management systems are a way for sites to enter those kinds of data, not only about GCP but training for other critically important scale such as the Rankin Stroke Scale or other kinds of scales that would be for which specific training and certification is required if you're going to use them in a clinical trial. 

 

By having that secure place where this information can be archived and then shared securely with sponsors, with IRBs, with regulatory agencies, it provides a very great value to sites. 

 

We anticipate there will be many, again, early adopters and they will participate in the ongoing ACRES foundation initiatives, actually help build this system. And then we'll continue. We're actually launching an effort now to begin the registration of sites globally through a number of different initiatives.

 

Koski: For a one-time investment of about $50 million we can build and implement the entire ACRES Global Network and have it become self-supporting in probably three and a half years. We're looking at this as a five year development effort. 

 

At the present time, the funding for ACRES has been provided through contributions from individuals and from companies in order to support the initial development. We've just launched a development campaign that’s a multi-pronged approach that will reach out to private foundations as well as industry sponsors, governments also, and this is an initiative that's very appealing to venture capitalists strangely enough. 

 

Ultimately as the network is actually implemented, we anticipate that there would be a variety of revenue streams that would come in part from the sites that would pay some form of a registration fee. They currently are not asked to at all. We're providing more to them then we're asking from them. That's a good place to start. 

 

We anticipate that a combination of user fees or/and registration fees. And there are also several potential models for generating fees from the providers of goods and services that would want to use the network in order to make their products available to the clinical research sites. 

 

Currently, there are no fees being charged to any of the sites for registration or sponsors. We are in fact reaching out to a number of major players in the pharmaceutical industry as well as the medical device industry, the CROs and private foundations in order to fund the initial building of the network. 

 

Koski: The approach that we're using is to send directed invitations to a number of organizations that have multiple sites. These are organizations that have been allies of ACRES since its inception. And we expect that many of these sites will bring large groups of sites into the network all at once. We are establishing regional bases in Asia, Latin America and Europe, likely in the Middle East and in Africa as well so that through these regional bases we will reach out to establish connections with sites on either a regional or a national basis in order to bring them into the network. 

 

Koski: We have about 75 individuals who are really senior leadership individuals from around the world that bring their expertise in multiple sectors to the development activities that are underway. In the executive office, we have myself as President and CEO and I also serve as Chairman of the Board of Directors at the request of the Board of Directors. Andy Olmsted and Beat Widler are the co-founders. Andy is our Vice President for Information Technology and Beat is the Vice President for Quality Management. And then we have Matt Whalen, our Chief Operating Officer; Brian Edwards is the Vice President for Safety and Pharmaco Vigilance; and Johan Karlberg, Managing Director of Clinical Trials Magnifier is VP for Site Development and support. 

 

We also have within the executive office, Diana Howard, our Director of Finance and Administration; Dennis LaCroix, who is our General Counsel; Mary Tobin, who is basically a jack of all trades, who works as a special advisor to myself and Matt as well as anybody else on the team who needs it. We have recently brought on board also Kate Madigan, who formerly was the, I believe the Executive Vice President or Senior Vice President actually of ACRO, the Association of Clinical Research Organizations, a CRO-based organization. Kate will be working with us also on a number of activities around, particularly around communications and the ACRES Alliance. 

 

This is the team that is basically coordinating what we call the matrix development of our foundation initiatives. When you're building a system you have to ensure that all of the components are actually developed in parallel and that they will all work together when they're finally completed. Each of our project steering committees is cross-fertilized with the other ongoing initiatives so that we have a high fidelity link to ensure that each group knows what the other is doing so that it all comes out to be compatible in the end.