Clinical trial experts have called for a new ‘toolbox’ to help simplify early-phase clinical trials in a new article published in the British Journal of Clinical Pharmacology to ensure patient safety and the advancement of novel therapies through development.
According to the article, Oxford University and Imperial College London’s professor Charles Vincent and Richmond Pharmacology’s Dr Ulrike Lorch stated: “Early phase trials… require a different approach to standards and guidelines akin to the ‘mass customisation’ seen in industry…, [which] allows products to be made to individual customer requirements.”
However, this is “only achievable because each of the many components is built in a standard fashion with rigorous quality control,” they added.
The authors stated that the clinical trial regulation principle should be to achieve “lean processes that can be easily understood and followed” and that the UK “needs a toolbox of standards, guidelines and local work instructions that can be customised to the requirements of any particular trial and patient group”, as opposed to more documents and checklists, to help bridge the gap between regulation and reality.
In an effort to achieve this objective, the authors proposed a number of recommendations, including the representation of experienced investigators and clinical researchers in the development of relevant regulations and guidelines; creating modules of regulation and regulatory guidance to be updated frequently to counteract the current lag in clinical trial practice; and certifying sites, researchers and investigators to achieve faster regulatory authorisation timelines for trusted organisations and personnel.
Despite this, the authors state that “rules are never sufficient to ensure safety in practice” and instead recommend that standardisation and compliance “should be combined with agility to adapt to change and innovation”, which will require the training of a whole new generation of researchers to manage risk and protect patients in early-phase clinical trials.
Similarly, in June, the European Medicines Agency announced the launch of two advisory pilots to improve the quality of applications for clinical trials in Europe, while the US Food and Drug Administration published guidance to assist drugmakers and medical device makers when submitting Diversity Action Plans to improve enrolment in clinical studies.