Last week INDICRO attended the IAOCR Clinical Research Industry Leaders Think Tank hosted in Liverpool. It was an exciting day where we were able to engage with industry representatives, members of the government and the NHS. IAOCR is the world leader in clinical research competence verification and accreditation. INDICRO supports the goals of the IAOCR in supporting the clinical research workforce with global standards and minimising risk to help safeguard patients. INDICRO attended the Think Tank as a sponsor, exhibitor and speaker with our Founder, Trish Parry on the first panel session focused on UK and EU regulations.
The day started with Angela O’Connell, Executive Board Director of GCSA speaking on why we need global best practice standards stating that over the last 5 years the FDA have reported a failure rate of 36% in clinical trial site inspections. This includes failure to follow the investigational plan, protocol deviations and inadequate record keeping. She also discussed how sites are currently run by medical professionals that lack expertise in clinical research business practices causing multiple issues for patients and commercial clients ultimately delaying innovative new treatments reaching patients.
The next speaker was Matt Westmore, Chief Executive at the Health Research Authority who stated that the UK is one of the best places in the world to conduct clinical research due to unrivalled research infrastructure and access to a large and diverse patient mix embedded within a system, the NHS. Additionally, while it used to take 620 days from first clinical trial application to go into the regulatory system to the first patient being either screened or recruited into a trial, it now takes 250 days, a significant improvement.
Simon Taylor from Florence Health also delivered a talk regarding the largest guidance change from ICH in 20 years covering the role of the sponsor/investigator, quality management, monitoring and oversight. He described how In the new guidance a stronger focus on trial design is seen with a less strict definition of an investigator and substantial amendments for handling electronic data and using e-systems. In relation to quality management there is a large focus on risks and risk management, specifically using risk as an assessment tool for decision making. Monitoring, renowned for being one of the most onerous tasks, according to the new guidance should focus on central monitoring and monitoring controlled in a risk-based approach where the monitoring plan is considering site capabilities ad potential burden.
This was a mere snapshot of the quality of speakers and level of expertise brought to the day. The central theme that emerged was the power of collaboration for enhancing industry standards and ultimately delivering excellent clinical research. Collaboration is a theme we believe in strongly here at INDICRO where we are harnessing the power of expert connection and collaboration for the advancement of medical product development. Overall, it was an educational and enriching experience. We were delighted by the interest expressed in INDICRO by various stakeholders and we look forward to next year’s Think Tank.
For more information visit https://iaocr.com/
