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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.