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Opinion: The new EU Clinical Trial Regulation fails to fully protect patient interests

I’m a lawyer who specialises in defending people who have suffered harm as a consequence of participating in clinical trials.

On 31 January 2022, the EU Clinical Trial Regulation came into force.

The regulation harmonises the processes for submitting and approving trial applications, and for overseeing drug trials, across Europe. The new CTIS trial registry will become the single gateway for applications to start up new Clinical Trials of Investigative Medicinal Products (CTIMPs).

The new registry will enable coordinated assessment of safety notices from drug trials in the European Economic Area, contributing to a better understanding of the benefits and risks of the medicines being investigated.

However, the rights of citizens (including trial participants, patients, consumers, insurance holders, etc) with respect to clinical trials are still not fully assured.

The new regulation is a step forward, but many areas remain where further improvements are necessary:

  1. ACCESS TO INFORMATION. Access to all information about a trial should be a fundamental right. This is still not the case. When a citizen wants to access to his or her individual patient data (IPD) collected during a trial, the sponsor can make it extremely difficult or imposible to access these data. The data are dispersed over multiple countries, making them nearly impossible to trace. The information chain is completely controlled by the trial sponsor and its sub-contractors. Transparency is further limited by legal protections for commercially confidential information.

  2. SAFETY DATA. In Europe, safety notices are not evaluated according to well-defined pharmacological causality criteria (such as the Bradford Hill or FDA criteria). The majority of suspected adverse events in Europe are not being correctly classified by trial sponsors. Furthermore, sponsors only publish safety data as and when it suits their interests. Publication bias remains a major issue, and this negatively affects the safety of citizens participating in clinical trials.

  3. INFORMED CONSENT. Informed consent should take the form of a formal contract between the trial participant and the trial sponsor, but this currently not the case.

  4. AUTOPSIES. There is no requirement for a mandatory autopsy when a clinical trial participant dies.

  5. ETHICS COMMITTEES. The supervision of clinical trials by ethics committees remains minimal.

Regardless of the crucial importance of clinical trials, individual citizens’ rights must always take precedence over any medical investigation.

The new European regulation is indeed a step forward, but much remains to be done to fully safeguard the interests and rights of citizens participating in clinical trials.

This guest blog was contributed by Francisco Almodóvar, a lawyer based in Spain who has twenty years of experience working in biomedical law. All contents of this blog are the responsibility of the autor alone. He can be contacted via email.


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