Years in the making, with dozens of experts and entities engaged in the back and forth discussions, the Alliance for Clinical Research Excellence and Safety (ACRES) just unveiled a global quality standard for clinical research sites aimed at raising the accuracy and integrity of data input from the very beginning of the process.
Too often, data errors “get baked in” at the beginning of a trial, according to Dr. Larry Kennedy, CEO of the Quality Management Institute (QMI) and vice president for quality management systems and chief quality officer at ACRES. Result: “They’re not discovered until they reach the other end,” he says. By that time, scary terms like “risk mitigation” and “legal strategy” begin to enter the conversation.
There’s frustration throughout the clinical trial industry regarding erroneous data being injected into the trial process, Kennedy says. “People are a little angry the errors keep showing up,” he explains, and adds that a more reliable, accredited process at the clinical research site would prevent much of that anger.
“Members of the Association of Clinical Research Professionals (ACRP) are the heartbeat of clinical trials,” Kennedy says. “They know the value of this kind of support.” Expecting some pushback after unveiling the standards, Kennedy instead reports a “good response” from the contract research organization community. “They are ethical people [who know that] as good as trials are now, they are not working as well as they should,” he notes.
ACRP’s initiatives to professionalize the clinical trial workforce and codify standards can work in concert with the work of ACRES to promote standards at the site level, experts agree. “Clinical trial professionals are doing excellent work today, and ACRP is committed to helping raise the quality bar even higher with professional standards, certifications, and better-defined career paths,” ACRP Executive Director Jim Kremidas says.
“I look forward to promoting site standards and certifications to promote excellence in clinical research,” adds Bridget Gonzales, ACRP’s director of training and professional development and a participant in the ACRES Site Accreditation & Standards Initiative (SASI).
The data standard is available for public review and comment (registration required) until October 31, after which an initial working standard will take effect. During the comment period, the standard will be “pressure tested” at selected sites already expressing an interest in attaining accreditation. Details of the process should be released later this year. Plans for pilot testing of the accreditation process are slated for early 2019.
Author: Michael Causey