A growing concern in the pharmaceutical industry has been that its approach to clinical trials, particularly on a global scale, no longer works. The rising cost of clinical research, difficulties in recruiting patients, tensions about ethical oversight in developing countries, dry pipelines and concerns about drug safety and efficacy have caused many forward-thinking industry leaders to explore new models for global drug development.

One such initiative, created by a nonprofit organization called the Alliance for Clinical Research Excellence and Safety (ACRES), has begun to gain momentum in recent months. ACRES wants to bring together pharmaceutical companies, regulatory agencies, ethics committees and other stakeholders to build a global clinical research system that would operate with a shared information infrastructure, standardized policies and operational procedures, and a third-party process that could accredit facilities, personnel and processes.

ACRES modeled its vision for a global network on the International Air Transport System (IATA), an independent organization formed by the major airlines in 1945. IATA worked with regulatory agencies from around the world to negotiate uniform policies and procedures to establish a global system for air travel.

“If we really want to do clinical trials globally, we need to move toward standardized policies and procedures. That is an achievable goal, as the airlines have clearly demonstrated,” said Greg Koski, Ph.D., M.D., associate professor of anesthesia at Harvard Medical School and senior scientist at the James Mongan Institute for Health Policy at the Massachusetts General Hospital and Harvard Medical School. “When the airlines formed IATA, there were many international differences in areas such as baggage handling, tariffs and various aspects of civil aviation. As IATA began to negotiate with regulatory agencies around the world, everyone could see it would be better to have a standardized approach. The result was a tremendous amount of regulatory simplification and streamlining that, in fact, enabled international air transportation.”

In addition to Koski, a former director of the Office for Human Research Protection, the organization’s principals are Andy Olmstead, director of member services and development at IRBNet in Cambridge, Mass., and Beat Widler, Ph.D., global head of quality at Switzerland-based Hoffmann-La Roche.

ACRES envisions its global network to include thousands of clinical research sites that would operate according to uniform standard operating policies and procedures. The sites would be accredited by independent local agencies according to internationally accepted standards, staffed by trained and certified professional personnel, operate under an accredited human research protection program and supported by a web-based information system that would allow tracking of trial progress in real time.

A nonprofit, non-governmental organization would head the initiative, set the relevant standards and build the technological infrastructure for the global system. Rather than start from scratch, ACRES wants to build this network using a best-of-breed approach, working with organizations from around the world that have already developed standards, tools and technologies to improve clinical trial processes.

“A centralized organization that is not-for-profit and not part of the industry can serve as an effective liaison between industry and the many other parties that are part of a global clinical trials process in order to achieve the kinds of improvements in safety, quality and efficiency to get products to market more quickly at a lower cost and with a much higher level of safety,” said Koski.

While Koski and his colleagues have discussed their ideas with like-minded individuals and associations for many years, ACRES has moved forward in recent weeks with the establishment of a web site at www.acresglobal.net. The International Federation of Associations of Pharmaceutical Physicians (IFAPP) has joined ACRES as a charter member. In addition, in the next six weeks ACRES will name its global advisory board, which will include 12 to 15 members from industry, the ethics community, regulatory affairs and information technology.  ACRES also plans to write its bylaws by June 1 and convene an international meeting for stakeholders in fall 2012.

Once established, Koski believes this type of global network could transform clinical research. Global clinical trials could be up and running at accredited sites in just a few weeks, compared with the many months currently required, at significantly reduced costs and improved productivity, quality and safety. “This global network could truly revolutionize the entire approach to clinical trials,” he said.

In addition, the global network could promote the conduct of ethical clinical trials worldwide, which has been a concern in developing countries that lack a well-established tradition of clinical research. “In building a system whereby the individual sites are all accredited and all have staff professionally trained and certified, the industry is actually investing in a sustainable capacity within these developing countries that contributes in a very important way to the economic viability of the regions,” Koski said. “At the same time, it’s not only addressing, but improving, ethical and safety issues because they are building it all according to global standards.”

--Karyn Korieth