The new standard results from a multi-stakeholder effort led by ACRES as part of its foundational Site Accreditation Standards Initiative (SASI) and is available for public review and comment until October 31, 2018.
The ACRES Quality Continuum Standard for the Quality Management of Clinical Research Sites (ACRES-QC S001:2018) has several sections and addresses: Clinical research site management and leadership; quality; risk; a people-centered workforce; person-centered care for clinical trial participants; clinical trial facility; evaluation/assessments and audits; and clinical research trial-specific data.
The standard will be “pressure tested” at selected sites during the comment period with details expected later this year and pilot testing plans slated for early 2019.
Drug development performance is not improving, “or is only improving piecemeal, in silos,” said Mary Tobin, PhD, chief strategy officer, ACRES.
As Tobin explained, the fragmented nature of policies, procedures, and processes burdens sites and creates inefficiencies. It also leads to high costs, prolonged time-to-market, and presents serious safety issues.
“One of the ways other high-risk industries, such as aviation, deal with this is through an integrated global system, including the development of globally shared standards,” she said.
For example, Tobin noted that the International Civil Aviation Organization (ICAO) develops, publishes and monitors more than 10,500 SARPs (standards and recommended practices).
“The medicines development enterprise lacks both such shared standards and mechanisms for oversight of standards if they existed,” she said.
Looking to the aviation industry as an example, Tobin commented – noting correlation is not causation – that in 2014 there were 3.3bn air passengers worldwide and 761 deaths. In the US, there were 4.0bn prescriptions written and 123,927 deaths, according to US Food and Drug Administration (FDA) Adverse Event Reporting System (FAER).
“Given most research is conducted at research sites, help is needed at sites to overcome the fractured nature of current processes and procedures,” explained Tobin.
If the goal is growing the number of high performing sites, she said the best way to assess performance levels is with standards: “They provide the requirements against which we can measure a site's performance and compare it.”
Tobin said the new Quality Standard is the result of a long process, which started in 2012. It was a global effort initiated prior to the US Institute of Medicine (IOM) Collaborative Working Group effort on US Accreditation, in which ACRES participated.
“While initially considering a range of standards domains, the team decided to create a standard for quality which provides the foundational basis for real-time site performance, harmonization, and oversight in all clinical trial site operations,” she said.
“ACRES has believed from the beginning that site standards and voluntary site accreditation must go hand in hand,” added Tobin. “Without site accreditation, there is no mechanism for ascertaining if a site is meeting the requirements set by the standard.”