The International Academy of Clinical Research (IAOCR) has launched a new patient safety campaign, just in time for the first ever World Patient Safety Day.
The campaign calls on the industry to prioritise ensuring the competence of those undertaking clinical research in-line with upcoming guideline changes.
The project, dubbed 'Don’t Risk Your Research', supports the imminent changes to ICH E8(R1), which focuses on factors improving the “quality” of clinical research specifically around the “Right First Time” approach to quality assurance.
'Don’t Risk Your Research' aims to raise awareness of the risks incompetence poses to patients, clinical research and organisations, as currently resourcing decisions are often based on years of experience and CVs or resumes (which there is a reported fraud rate of approximately 17%) rather than evidence that people can perform the job competently.
The IAOCR reminds that the individuals undertaking clinical research are ultimately managing patient safety, multi-million-dollar investments and future, advanced treatment options, which is why competence of these individuals is key.
“Clinical Research is central to the development of all upcoming treatment options. Incompetence places patients, clinical research and organizations at risk so it is shocking to us that the industry is not proactively ensuring that everyone involved in clinical research is qualified through competence” explained Jacqueline Johnson North, chief executive officer of Future Shaper Holdings, IAOCR’s parent company.
“At IAOCR we are dedicated to pioneering best practice and ensuring appropriate checks and balances are in place so that patients and Sponsors can feel confident and reassured. Our campaign coincides with the ICH E8(R1) guideline updates which we fully support. We are urging all sponsors and Clinical Research Organizations to ensure that their clinical research workforce has been robustly competence checked to international standards.”
The WHO (World Health Organisation) has launched the first-ever World Patient Safety Day on 17 September 2019, to “create awareness of patient safety and urge people to show their commitment to making healthcare safer.”