Opinion

18 July 2025

Why cancer patients deserve to know the outcome of a clinical trial

A patient and a doctor sitting at a desk

When living with cancer, participating in a clinical trial is not a small decision. It means extra visits to the clinic, more tests and treatments on top of everything else you're already facing. You participate in the trial with the hope that it might help — and if not you, then others in the future.

Yet despite this effort, it’s still common to never receive any information about the outcome of the trial. Although researchers put their energy and time in analysing the results. And even though most trial participants want to be informed about the study findings.

It’s like campaigning tirelessly for a political candidate, without ever finding out who won the election in the end.

This is a shame

Being informed about the study results can bring closure, recognition, and a sense that your efforts were part of something bigger. Sharing results isn’t only respectful, for many patients it’s an important part of their process of facing their cancer. The responsible parties behind the clinical trial have an ethical and moral responsibility to honour these important benefits.

Please take note: this blog is not about making results public through a registry or publication in a scientific journal. It’s about actively reaching out to patients that have participated in the trial to inform them about the results directly, in a language and manner understandable to a non-scientific audience in addition to any findings made publicly available.

Why sharing study results with participants matters

Key reasons for sharing results include:

respect for the participants’ contributions;
increasing the transparency of scientific research;
public understanding of research which could in turn improve participation in clinical trials - patients with a positive experience will be more inclined to participate in other research and to bring this message to their environment as well.
building trust in researchers;
potentially useful for them and others when making decisions about their health.

So, while the ethical case for communicating results is clear, the current regulatory landscape tells another story.

Clinical trial regulations: current requirements for result sharing

Worldwide

The Declaration of Helsinki states that all medical research participants should be given the option of being informed about the results of the research. The Declaration of Helsinki is a set of ethical guidelines for doctors and researchers on how to treat people who take part in medical research created by the World Medical Association following the atrocities by physicians conducting unethical medical research during WWII. Unfortunately, it’s not legally binding thus not enforceable.

Europe

The EU's Clinical Trials Regulation (EU No 536/2014) stipulates that researchers must upload a summary of trial results on the European Clinical Trials Registry (CTIS) including a layperson summary, within 12 months after the end of the trial.

EU regulation doesn't require participants to be directly informed of results. They must actively seek them out in registries or journals—and first be aware that results exist. Most reports are in English, posing an extra barrier for non-native speakers.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), representing pharmaceutical companies in Europe, has established “Principles for Responsible Clinical Trial Data Sharing” in 2013, including one on sharing results with study participants. Unfortunately, contacting participants directly is not discussed.

USA

In the US, the Food & Drug Administration (FDA) also mandates uploading a summary of results to clinicaltrials.gov within 12 months of study end. Here, publishing a lay summary is only ‘recommended’.

Privacy

But, if a researcher or company does intend to directly contact the patients there are some conditions in terms of data protection laws (GDPR in the EU, HIPAA in the US), most importantly that patients can only be contacted for results if they provided written consent.

Despite the regulatory requirements for public disclosure, less obvious obstacles still prevent direct communication with participants.

Barriers to disseminating research findings

While the importance of informing trial participants about the study findings is generally acknowledged, those responsible often face practical and institutional barriers when attempting to do so. These include lack of resources (cost, people and time), unclear responsibilities, legal concerns, missing guidance and challenges in communicating complex findings to a lay audience.

Institutional barriers

For non-commercial trials, a challenge lies in institutional prioritisation: the focus is often on publishing results in scientific journals, for which investigators receive recognition, rewards and incentives. In contrast, there is typically no clear system in place to support the direct communication of results to patients in a way that’s meaningful and accessible to them.

Timing

Some research teams feel that trial results should be reviewed by peers and published in a scientific journal first, to make sure the information is accurate and complete. They may also hold back from sharing results because of embargoes, or worry that if the media reports on the trials findings too early, journals will no longer be interested.

Also, the time lapse between recruiting participants, their study participation and when the data are analysed and ready to be disseminated, poses a problem. It often takes months or years to get results, and especially in oncology trials, patients may have passed by the time results are out.

For industry-sponsored trials specifically, the barriers may vary according to the stage of the trial and company goals.

Ethics Committee requirements

Many researchers are unsure about Ethics Committee’s requirements for contacting participants about results. They worry it means an extra administrative burden, especially if the topic of contacting patients after the trial wasn’t included in the original trial application.

For example, many think that they need Ethics Committee’s approval of the summary of the findings. This is not the case. For trials that have incorporated the data sharing plan in their initial application, no additional approval is needed.

Whether the Ethics Committees themselves are prepared for inquiries on this topic is another question, which remains to be answered at this point.

Fortunately, recognition of those challenges has sparked the development of practical solutions.

Resources and tools for clinical trial result communication

As awareness is increasing, organisations have started developing tools and guides to support researchers and companies in sharing results with participants.

The National Health Service (NHS) in the UK offers free, detailed guidance on communicating study findings to participants. Parkinson’s UK developed a research communications toolkit to use throughout the trial, with a section on sharing results.

In 2021, the European Commission published Good Lay Summary Practice (GLSP) Recommendations on developing and sharing accessible summaries of trial results to the public.

While these initiatives are encouraging, much more remains to be done. We need a comprehensive approach for transforming how we communicate with trial participants.

The way forward

If we want to make distribution of research findings to the participants a consistent practice, it seems to be imperative to include this in the current regulations and thereby make it enforceable. In addition, there is a clear need for guidance on how to manage the process of informing patients of study results directly. Institutions should support the investigators by providing a framework, resources, and practical tools for a change in practice.

Plan ahead: how results will be reported needs to be part of the study plan from the beginning. When doing so, researchers and companies should consider involvement of relevant persons like patients, nursing staff, and other advocates early in the preparation of a trial. By doing so, it limits the administrative burden and extra cost at study end.

For non-commercial trials, funders should make it mandatory to have a plan for sharing research results in the application.

Funds should be provided to account for resources needed, both for non-commercial as for company sponsored trials. When applying for grants or funding, these costs should be included in the application.

As a funding organisation, Anticancer Fund will do its part to make sure results of funded trials are disseminated in an ethical and patient-friendly manner.

References

James Lind Institute. (2020). Patient insights: The need for patient feedback.

Sgro, L., et al. (2023). Contemporary Clinical Trials Communications, 33, 101136.

South, A., et al. (2023). Addressing barriers to sharing results with trial participants. Learning for Involvement, 2025.

South, A., et al. (2023). Clinical Trials, 20(6), 649–660.

McElfish, P. A., et al. (2019). Journal of Clinical and Translational Science, 3, 295–301.

George, S., et al. (2023). Health Expectations, 26, 765–773.

South, A., et al. (2025). Trials, 26, 107.

The Declaration of Helsinki is a set of ethical guidelines for doctors and researchers on how to treat people who take part in medical research created by the World Medical Association following the atrocities by physicians conducting unethical medical research during WWII.