Jacqueline Johnson North, CEO of the accrediting organization IAOCR, told us the GCP loophole means that there is no requirement for proof of competence to undertake clinical trials.
The Guidelines state the requirement for individuals be qualified through education, training, and experience.
“Just because you’ve got a degree, completed a training course and done a job for a period of time it doesn’t mean you can do a job well,” North said. “I’m sure most people can think of examples to the contrary and this in essence is the loophole.”
However, North explained it’s important to note that the issue is not about training, “it’s about the embedment of intrinsic, robust business processes focused on workforce quality.”
“It is very hard to comprehend that there is a such a relaxed approach about such a pivotal part of a highly regulated industry,” she added.
“The safety implications of this loophole are very concerning and from a commercial perspective, it simply doesn’t make sense. Competent staff are absolutely paramount in order to run clinical trials effectively and efficiently.”
Closing the loophole
North explained a robust competence-based approach provides CROs with a business process that can be embedded into the organization as part of an ongoing quality system.
“When we speak with regulators and clinical research organizations about this matter everyone agrees it makes sense. It provides a far more reliable way of assessing whether someone is fit-for-purpose,” she said.
Currently, the organization is working with CROs, sponsors, and clinical packaging companies that are already addressing the issue. “Unfortunately, however, there are a number of organizations that understand the importance of this, but won’t proactively take action unless it becomes a regulatory requirement,” she added.
As such, North said ICH needs to look at the companies leading in best practices and “respond accordingly” to raise standards across the board.
“Closing this loophole helps CROs to deliver strong, reliable trials efficiently; which will ultimately mean that new treatments can be brought to patients quicker.”