HMA publishes recommendations on complex clinical trials of personalised medicine

11th March 2019 (Last Updated March 11th, 2019 12:01)

A subgroup of the EU’s Heads of Medicines Agencies (HMA) has published a set of common recommendations with regard to conducting complex clinical trials of personalised medicine.

The HMA’s Clinical Trials Facilitation Group (CTFG), which is coordinated by the Danish Medicines Agency, has identified eight key recommendations to establish a framework on the initiation and conduct of clinical trials.

The recommendations focus on ensuring a continuous assessment of the effects as well as side effects of investigational medicinal products along with the trial subjects’ safety and data transparency.

Additionally, they define what may reasonably be considered a complex clinical trial and what should be considered as separate clinical trials.

For these complex clinical trials, the Danish Medicines Agency has coordinated the working group and is planning a meeting for the industry on 30 April this year on the new recommendations.

Danish Medicines Agency said in a statement: “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.”

HMA published the latest recommendations in recognition of the fact that clinical trials with trial subjects are becoming complex.

With these complex trials with trial subjects, new medicines that can be tailored to an individual patient with a specific genotype can be developed.