The Balance Between Innovation and Protection of Trial Participants Under Clinical Trials Regulation (CTR)

The Balance Between Innovation and Protection of Trial Participants Under Clinical Trials Regulation (CTR)

The Clinical Trials Regulation (CTR) entered into application on Jan 31, 2022, appealing the existing EU Clinical Trials Directive 2001/20/EC. Changes on the assessment and supervision process of clinical trials would be carried out throughout the European Union. A singular platform, the Clinical Trials Information System (CTIS), is established to accelerate the harmonization of internal market where access is granted to reliable and robust data as the goal of the system is to create a favorable environment to conduct clinical trials in the EU. However, the progressive push to eliminate regulatory burdens also raises concerns for participant safety and privacy in which this paper will assess the interplays between Clinical Trials Regulation and General Data Protection Regulation. The advocation on clinical trial data transparency also contests commercial interest, however, the paper supports benefit sharing and the promotion of public interest with considerations of intellectual property protection. With transparency requirements of CTR, it is debated on whether it could be juxtaposed under data protection and intellectual property protection regime. While discussing the balance between innovation and protection of trial participants under Clinical Trials Regulation, the paper concludes in the adequate mitigation of CTR while proposing recommendations for further improvements with the inclusion of AI.