主催: 日本臨床薬理学会
The role of early phase principal investigators (PI) changed significantly over the last decade. It shifted from clinical pharmacology trials with healthy volunteers to applied human pharmacology trials that require a different set of PI capabilities.
Most investigational medicinal products now used in clinical trials are biologicals and advanced therapies, including gene silencing and in-vivo gene editing. Many therapies can only be trialled in patients with the relevant diseases, which may be rare or common, with diverse patient populations. These trials require expert PI medical oversight and focus on clinical risk management, as well as specialist oversight of non-medical aspects and close collaboration with other experts.
The UK put in place a PI accreditation scheme following the Tegenero incident in 2006. To adjust training and accreditation to our current environment, a group of stakeholders have joined forces to update the scheme.
The three main aims are:
(1) To make capability assessments relevant to the new early phase trials environment
(2) To make the programme accessible to all (prospective) early phase PIs who want to obtain or expand their capabilities
(3) To make the programme attractive and to provide certification
The stakeholder group consists of experts in clinical disciplines, clinical pharmacology and pharmaceutical medicine, as well as representatives from UK regulators.
We found that the scope of work and relevant capabilities of early phase PI vary significantly, depending on their background and workplace. However, we were able to agree on a curriculum of areas of core capabilities early Phase PI need to have, irrespective of their scope of work.
We envisage an open, flexible, modular assessment and certification programme, that PI from all disciplines can tailor to their scope of work and their own professional development.
My presentation will give an update on the status of the project and our vision for the future.
