AN INTERVIEW WITH Greg Koski, PhD, MD – Clinical Researcher

Clinical Researcher June 2014

AN INTERVIEW WITH Greg Koski, PhD, MD President and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES) PEER REVIEWED

Laurin Mancour, CCRA, CCRP [DOI: 10.14524/CR-14-00006.1]

For this issue of Clinical Researcher, I interviewed the President and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES), a nonprofit organization operating in the public interest, which has entered into a strategic alliance agreement with ACRP to focus on the education, training, and credentialing of global clinical research professionals.

This partnership enabled the two organizations to join forces to address such mutually desired outcomes in clinical research as well-educated citizens, secure and efficient processes, transparent communication of credentials and certifications, and stronger professional development standards for clinical research professionals. A long-desired step toward these goals is the unification of standards and credentials, which is already taking hold as a trend in many industries and professions similar to drug and device development. The ACRES/ACRP agreement promises to be a significant and essential step toward realizing improvements in clinical trials on a global scale.

Q: How did ACRES and ACRP come to be involved with each other? 

A: ACRP and ACRES have a strategic alliance to work together to realize each other’s missions and visions. That relationship, in no small part, comes from those of us in the ACRES Executive Office having long been involved in ACRP. For recent examples, our general counsel serves on the ACRP Board of Trustees (as I have in the past); one of our vice presidents has just been appointed to the ACRP-affiliated Academy of Physicians in Clinical Research (APCR) Board of Trustees; and our chief operating officer has just completed his final term on the ACRP Board’s Nominating Committee. Others of us have served on ACRP’s Editorial Advisory Board and other committees. In short, it has been a longstanding relationship.

Q: What does this strategic alliance involve? 

A: In addition to being a general agreement to support each other’s work, there are specific projects on which ACRP and ACRES will collaborate, for example, supporting certification of clinical research professionals globally and the related education and training that involves. Beyond projects, and at least equally important, are leveraging the relationships of the two allies.

Q: How do you see that being realized? 

A: Between ACRP and ACRES, there is an extensive international network that can help to transform the conduct of clinical trials—their safety, ethics, and efficiency. The areas of interest of the two organizations are naturally conjoined, and it is in the interests of both to take advantage of this. Both organizations contend with the issues of safety, quality, and efficiency in a multitude of regulatory frameworks and jurisdictions and promote industry best practices. Similar collaborations in other industries dealing with these issues can be seen as examples of how this kind of agreement can enrich all stakeholders involved.

The advantage of ACRP working so closely with ACRES is our global approach to the issues facing our industry. ACRES has taken a step forward and applied a global integrated systems approach to our goals, which grants some powerful efficiencies for the benefit of both parties.

Importantly, too, both ACRP and ACRES have relationships with a number of organizations, including other nonprofits, to encourage change without duplication of effort. This is change at an institutional level, but in consideration of the global nature and progressive educational developments of the industry, it is an essential and necessary step toward a more unified approach. Considering the digital, global environment we find ourselves evolving toward, now is the time to revise our current processes to be more sustainable and effective. Also, given the amount of resources these kinds of change-efforts take, this kind of alliance between organizations is a practical way of getting things done—collaboration, not competition.

Q: Because this issue of Clinical Researcher focuses on achieving excellence through education and training in clinical research, what is ACRES doing in addition to promoting certification of clinical research professionals and the supporting education and training that involves? 

A: We in ACRES think of education and training as part of an overall system of development, that is, development in the sense of sustainability of clinical research wherever in the world it is conducted. That demands practical, real-world tools for all the stakeholders involved in research, including, but not limited to, the core clinical research team and the site. For education and training, it also means access and media, like e-learning.

Q: So will ACRES be providing training for members? 

A: ACRES does not intend to provide training under this agreement. Rather, ACRES aims to support and promote more accessible and high-quality training and development options by working with our allies. For ACRES-affiliated sites, this begins with enhancing awareness of what educational and professional development tools are available through a range of providers. Using our relationships with sites to promote professional development of individuals and teams is one of the unifying goals of this partnership; sometimes that can be as simple as calling a valuable resource to someone’s attention.

For example, one of our allies, HealthCarePoint, makes its repository of education—and a tool for tracking personal experience and training—available as one of the services offered to affiliated sites at no cost through the ACRES Global Network. The repository and its range of training available are impressive, and obviously of value to more than sites. By sharing that information through ACRP through communication to individual members, a valuable educational and professional development tool becomes more widely accessible, which benefits both sites and individual professionals.

Another example of how we approach development in an integrated systems perspective is the way we seek to guide industry practice through the establishment and promotion of sound policy and sound implementation—what we call our Foundation Initiatives. One of the initiatives is dedicated to establishing and promoting a Safety Culture, from adverse events reporting through risk evaluation and mitigation. Mere adherence to procedure may be technically adequate, but in order to ensure the best possible and most ethical clinical research, you have to embrace a more comprehensive “safety first” operating philosophy than we have now.

Building a Safety Culture requires a different mindset and operating behavior that takes human factors into account and covers a lot of ground that isn’t necessarily addressed in regulation. It also includes translating methods and techniques from other industries, like aerospace and nuclear energy, where safety is paramount and “engineered-in”— safety by design.

Ensuring research subject safety is an absolute priority for everyone involved, but Safety Culture has to be nurtured through promoting and championing specific practices. This means both structural change and learning how to implement it.

Two final thoughts on education and training:

  • First, it’s pretty obvious in our industry that education and training are clearly not limited to just classroom or remote kinds of learning. On-the-job experience and mentoring are critical to the success of both individuals and organizations. Understanding how professionals and organizations actually develop and sustain themselves—and using that knowledge to provide more effective programs—is essential to make the most out of scarce education and training resources.
  • Second, members of the public—and the media that they rely on—need to better understand clinical research. ACRES recognizes that public education, as well as professional education, is an essential part of an integrated systems view of development and sustainability for our industry. Our Foundation Initiatives and other efforts always have public education in mind.

Q: You discussed the ACRES Foundation Initiatives. How will they help change how we do clinical research? 

A: Simply put, these initiatives are the ACRES engine, as it were, to implement change to push quality in clinical research across the board. By identifying sound policy and best practices, we promote a higher quality product overall. In addition, by taking an integrated systems approach, they are intended to work together—in matrix fashion—so that the changes that are implemented are not piecemeal or counter to other promoted policies and practices.

We felt it was essential that these initiatives not be perceived as “silo” or piecemeal solutions, but as a comprehensive and well-integrated system of policies, standards, and practices with tools to support them effectively.

[Note: Articles in The Monitor have addressed the concerns of organizational silos in clinical research, typically meaning the separation of functions in an organization into distinct and often-conflicting interests and purposes. Here, ACRES is also referring to silos between stakeholders in research, ranging from sponsors to research overseers, such as ethics committees and regulators.] 

Q: Do you mind going into more detail about the key operational initiatives that ACRES is developing? 

A: The ACRES initiatives focus on sustainable best practices and implementation to achieve high-quality clinical research for the range of stakeholders that make up the research community. For example, the SASI (Site Accreditation and Standards Initiative) Steering Committee, which includes representatives from multiple stakeholders on a global level, has focused on basic performance standards in five key areas: personnel, information technology, ethics and integrity, standards, and facilities. Others, such as accrual and retention, will also be included.

Soon, a report will be published describing the work that has gone into SASI, as a prelude to convening a Global Stakeholders Consultation and creating working groups to develop specific standards in each of those critical areas. These working groups must represent all stakeholders—especially sites, sponsors, and regulators.

Once the first versions of standards have been developed, the Steering Committee will engage a much larger group of stakeholders to solicit feedback and hone the standards. The standards and practices will be “pressure-tested” in working environments before they are moved forward to a final set of accrediting standards.

We anticipate this process may take about three years, although we will already be nearly a year into it when this interview is published.  We are also working in collaboration with other efforts, such as that of the Institute of Medicine, which is U.S.-focused, whereas ACRES is globally focused. However, in order for SASI to be a success, we have to establish accreditation as a valuable proposition.

Q: How is that process coming along? 

A: In addition to promoting the value proposition and developing the standards, the first phase of affiliation with sites is also under way. ACRES has provided this affiliation free of charge, in order to remove any potential barriers to affiliation and eventual accreditation. To that end, last year we rolled out a new site network information interface, which allows sites to register as an affiliate of the ACRES network, indicating their commitment to excellence and safety and to move toward being qualified by adopting the quality, safety, and professionalism standards of SASI.

Any site interested in participating can visit a web-based platform and register for free to become affiliated. Doing so will include the site as a beta test site, granting it access to the system that allows its staff to participate in training initiatives and contribute their perspectives to the network. Beyond affiliation and accreditation, this interface and system provide an efficient tool for sites to demonstrate their qualifications to sponsors, but there are other benefits, as well.

Q: What are some of the other benefits of sites registering their affiliation with ACRES? 

A: Sites are provided with a set of tools for promoting compliance and improving productivity and sustainability. This includes applications that can allow sites to archive all of their experience and training records in a safe, secure, but sharable space. This information can then be shared with regulatory authorities, institutional review boards, and sponsors in a transparent yet secure environment.

With more than 148 clinical trial management system (CTMS) providers currently available, different formats may cause interoperability challenges for research sites. To promote consistent processes and information sharing, data need to be supplied, shared, and stored in a consistent manner.

Sites that register with ACRES will use safe, fully validated exchanges of electronic information, and will adopt Clinical Data Interchange Standards Consortium standards for their CTMSs. They will become beta affiliates that have opportunities to test some of the quality management applications and programs, including self-assessment tools, a standard operating procedure template library, and ultimately tools for accreditation support.

Eventual costs for supporting site accreditation must be low, since it will need to be an accessible value proposition for sites across a range of social, financial, and global environments. These processes and systems are intended to open doors and foster opportunity for all involved parties.

Q: How is ACRES focused on regulatory issues? 

A: ACRES is also addressing regulations and guidance. Simplification and standardization have dominated the debate thus far, but regulatory innovation is no less critical to enable regulating authorities to keep pace with the speed of science and technology.

This is where the ACRES integrated systems perspective is invaluable. Our approach is to address simplification, standardization, and innovation simultaneously—another example of how thinking in terms of systems yields the most viable results.

Finally, any discussion of change in biomedical research and development regulation quickly finds itself immersed in risk-based and continuous quality concerns, which are addressed by another ACRES initiative.

Q: Since you personally have been so involved with ACRP over the years, is there anything else in particular our members might be interested to know about ACRES? 

A: ACRES is not a trade association, professional society, lobbying group, or membership-driven organization. It is a nonprofit networked organization intended to promote and sustain superior quality clinical research while operating in the public interest.

On a practical level, ACRES seeks to engage all stakeholders in the extended clinical research enterprise in the public interest. In this sense, “public” means both the interests of our industry professionals and of the public in general, whose members depend upon our best efforts to improve their healthcare and quality of life.

The way we will accomplish our mission of change is systems-based, which in its most fundamental way means developing solutions to essential problems where the interests and processes of research constituents—stakeholders—are connected and interoperable. That way, unintended consequences don’t create more problems than the solutions.

ACRES sees the research site as the fundamental building block of the system—like a personal computer connected to a larger enterprise network. Information is supplied, stored, archived, and used effectively to allow for the various requirements to be met (set by the various users and stakeholders in the system). However, in order for there to be appropriate standards and maximum efficiency, site-based systems need to be compatible with the other stakeholders in the network.

ACRES sees its efforts at unifying standards and promoting global site accreditation as fundamental to the network and constructive innovation. Furthermore, like ACRP and APCR, our mission is global, which means developing and redeveloping countries, as well—all nations that have clinical research as a public healthcare and economic priority.

ACRES aims to support unprecedented access to research to benefit every stakeholder. We look forward to a very productive, long-term relationship between ACRES and ACRP. The ACRES initiatives focus on sustainable best practices and implementation to achieve high-quality clinical research for the range of stakeholders that make up the research community

Laurin Mancour, CCRA, CCRP, is president and principal consultant for Atheneum Consulting, LLC, in Durham, N.C., and a current member of the ACRP Board of Trustees. In 2011 she also was the inaugural recipient of ACRP’s Advancing Awareness in Clinical Research award. She can be reached at 57

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