Common European recommendations establish a framework for testing medicines of the future

08 March 2019

The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.

The medicines agencies in the EU have just published a set of common recommendations on how to conduct complex clinical trials of personalised medicine. The recommendations have been published on the website of the common European Clinical Trials Facilitation and Coordination Group (CTFG).

The recommendations focus on ensuring a continuous assessment of the effects and side effects of investigational medicinal products, the safety of trial subjects and transparency of the data being used; they also define what may reasonably be considered a complex clinical trial and what should be considered as separate clinical trials.

Complex clinical trial

The recommendations have been prepared in recognition of the fact that the development of personalised medicine is gaining ground and clinical trials with trial subjects are becoming more and more complex. New medicines have traditionally been developed in relatively simple randomised trials in which the effect of a new treatment is tested against a standard treatment in a large group of patients. The development of personalised medicine usually takes place with fewer patients who are selected, for example, based on their specific DNA profile.

These complex trials with trial subjects offer the opportunity to develop new medicines that can be tailored to an individual patient with a specific genotype. The development of this type of medicines has made rapid progress in recent years – especially in the cancer area.

Need for common European guidelines

The increased complexity of the trials may expose trial subjects to greater risks. Likewise, the quality of data can be deteriorated, and the trials could be difficult to comprehend. Consequently, common European guidelines have been needed to harmonise the conduct of trials while ensuring high-quality data and the safety of trial subjects.

The CTFG is formed by the network of the heads of the medicines agency in Europe known as the Heads of Medicines Agencies (HMA). The Danish Medicines Agency has coordinated the working group for complex clinical trials.

Read the new recommendations on complex clinical trials here:Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials.

 Industry meeting on the new EU recommendations

The Danish Medicines Agency is planning a meeting for the industry on 30 April on the new EU recommendations on complex clinical trials.

What is personalised medicine?
Personalised medicine is developed to better match the genes, physiology and lifestyle of the individual person. Traditionally, medicines have been developed as a standard therapy for everyone suffering from a specific disorder.