The Declaration of Helsinki has been revised. It provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research. The SCTO has published a whole series of articles on decentralised clinical trials and complex clinical trials designs. And don't miss the new Swiss-UK bilateral funding for collaborative clinical trials.

Revised Declaration of Helsinki

The Declaration of Helsinki is the global reference for medical research involving human participants. The Declaration of Helsinki was revised in 2024 to reinforce the ethical standards.

The revised Declaration of Helsinki was published on 19 October 2024 by the World Medical Association (WMA). Among other revisions, it provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research.

The substantive changes to the Declaration of Helsinki can be categorised into two key areas:

• participant-centred inclusion, respect, and protection, including the recognition of participant vulnerability, calls for community engagement, the pursuit of global justice, obtaining informed consent, and the use of participant-centred language, and
• research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks, and burdens. 

For more details, consult the WMA press release and the links within.

Swiss Clinical Trial Organisation (SCTO)

In the ninth issue of Regulatory Affairs Watch of the SCTO, some innovative developments in clinical research are presented, namely decentralised trial approaches and complex clinical trial designs. The issue includes a range of articles and viewpoints on these promising and challenging developments.

In the autumn of 2024, the SCTO Education Platform ran a second round of seminars series “Facts and pitfalls of observational studies - How to plan and conduct HRO projects”. You can download here session materials (videos, presentations, Q/A).

New Swiss-UK bilateral funding

The UK National Institute for Health and Care Research (NIHR) and the Swiss National Science Foundation (SNSF) are partnering on a bilateral call for clinical trials to support early-career research capacity strengthening. Researchers are encouraged to begin assembling research groups as early as possible. To further these efforts, researchers can access support from the SNSF’s Scientific Exchanges scheme and the (NIHR) Research Support Service (RSS). The call for this bilateral clinical trial funding opportunity will open in April 2025. Do get in touch with the SPR if you wish to apply.

More information here.