European trial dating
In respect of the relevance, various aspects should be taken into account, including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment of medicinal products and the authorisation of their placing on the market and whether surrogate end-points, when they are used, are justified.
Unless otherwise justified in the protocol, the subjects participating in a clinical trial should represent the population groups, for example gender and age groups, that are likely to use the medicinal product investigated in the clinical trial.
No minimal timelines for approval should therefore be established.
This makes it in particular difficult to perform a given clinical trial in several Member States.
Scientific development, however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information.
The Member States concerned should cooperate in assessing a request for authorisation of a clinical trial.
This cooperation should not include aspects of an intrinsically national nature, such as informed consent.
Moreover, it should be ensured that, within the extension period, there is always sufficient time for assessing the additional information submitted.
The authorisation to conduct a clinical trial should address all aspects of subject protection and data reliability and robustness.
Member States should efficiently assess all clinical trials applications within the given timelines.
A rapid yet in-depth assessment is of particular importance for clinical trials concerning medical conditions which are severely debilitating and/or life threatening and for which therapeutic options are limited or non-existent, as in the case of rare and ultra-rare diseases.
In order to improve treatments available for vulnerable groups such as frail or older people, people suffering from multiple chronic conditions, and people affected by mental health disorders, medicinal products which are likely to be of significant clinical value should be fully and appropriately studied for their effects in these specific groups, including as regards requirements related to their specific characteristics and the protection of the health and well-being of subjects belonging to these groups.