In response to criticisms voiced by certain NGOs and medical groups about the adaptive pathways pilot project and its aims, EFPIA would like to be very clear that adaptive pathways will in no way lead to the lowering of evidence standards, nor the acceleration of access to medicines at the expense of efficacy and patient safety – which remain of paramount importance in our view. 

Scientific and technological progress today offers us the capability of understanding diseases in a comprehensive manner and of identifying patients who would respond to a specific treatment. 

By preselecting – including by identifying biomarkers – those patients that are likely to respond, the size of clinical trials may be reduced and run even faster. Moreover, the level of evidence obtained would be the same, or even higher.

Finally, by adding real world data earlier on in the process, we will provide even more relevant evidence for other decision-makers, such as HTA bodies and payers.