The costs of complying with requirements for clinical trials are “skyrocketing” for academic health centres, says the organisation that represents them in the US.
According to the Association of Academic Health Centers, some institutions have reported cost increases of as much as 70% in a single year. The money is going on infrastructure, personnel and information technology systems to manage clinical trials and the associated compliance burden, the AAHC notes, adding that cost is “a national issue confronting the academic health centre enterprise."
Compliance functions including budgeting, billing, training, auditing and monitoring are being “transformed” within academic health centres to ensure that clinical trials remain a central element of their research mission, the association comments. Yet the growing number of regulatory requirements has to be met with “limited and strained resources."
Despite these concerns, expressed in a statement on ‘Investing in Clinical Trial Compliance’, and the shortage of personnel available to help increase the efficiency and effectiveness of compliance systems, academic health centres need to place the issue among their highest priorities, the AAHC insists.
“Ultimately, patient safety and the public’s trust in the institution must be the guiding forces in all aspects of clinical trials compliance and the issue against which all expenditures of effort and finance should be judged,” it states.