The partnership will focus on developing and adopting global standards and performance metrics as the basis for clinical research best practices and guidelines. iCTRS brings expertise in global, data-driven decision support systems, advanced informatics technologies and a patient-centric approach for trial acceleration.
Otis Johnson, VP of clinical research services at iCTRS, will join the steering committee of ACRES’ Site Optics and Quality Informatics Initiative as part of the partnership.
Johnson told Outsourcing-Pharma.com, “Judging from the recently concluded Institute of Medicine (IOM) working group on standards and accreditation in which ACRES actively participated, industry – including both sponsors and CROs – see the tremendous value of standards and metrics.”
According to ACRES, the industry squanders $20bn annually due to inefficiencies in drug development and uniform global standards for research sites and independent third-party accreditation are still lacking, as are interconnectivity and interoperability.
“ACRES is invested in building a global system, with appropriate standards and methods, for clinical research. inVentiv Health, as part of our Tech Consortium, is especially strong in standards for technology as well as the global standards and performance metrics related to research sites,” Johnson said.
inVentiv claims to have directly supported the development and/or commercialization of 60% of all drugs approved by the US FDA in the last five years.
Industry group TransCelerate has a head start on ACRES, with mutual recognition of GCP (good clinical practice) training and other site qualifications . As far as how much ACRES’ work will overlap with industry group TransCelerate, Johnson told us: “It is not so much an overlap as different mandates. TransCelerate’s constituency is Pharma sponsors, and they are working on issues from the vantage point of one, albeit very important, stakeholder group.
In contrast, ACRES is a multi-stakeholder alliance-driven non-profit operating in the public interest. “One of ACRES roles is to breach the silos that surround each stakeholder group and bring them to the table such that they can collaborate on solving the issues bedeviling the current clinical research endeavor,” Johnson said, noting that both sponsors and CROs are both important stakeholder groups. TransCelerate recently made it clear that CROs will not be allowed to be members of TransCelerate.
“That said, one member of ACRES’ Board of Directors serves in the same capacity on TransCelerate’s. And, in general, we stay informed of each other’s efforts,” Johnson added. “As other industries have found, an integrated global system of common standards, regulations and procedures acceptable around the world, with a focus on safety, ethics and quality, brings order into chaotic situations and benefits everyone.”
But he also stressed that this “is a tall order and no one organization, or even one stakeholder group, can possibly create such a system alone. It will take the efforts of everyone -- including regulators -- involved in clinical research.”
As far as when ACRES plans to ramp up its efforts in global standards, Johnson told us the group has an overall 5-year plan that is continuously reviewed and updated. “That plan has profited from the volunteer input of over 90 executives, senior managers, and subject matter experts representing the multiple stakeholders in clinical research; as well as the active engagement of approaching 50 strategic allies,” Johnson said.