People who take part in a clinical trial often have to undergo many tests and trial visits, and it involves a significant effort on their part. But at the end, they are left with little information on whether the trial was successful or not, or how they contributed to the trial results.
Every patient taking part in a clinical trial has the right to request their own data back, under the EU Clinical Trials Regulation.
However, many patients don’t know that they can do this, and receiving data back is not straightforward. For instance, releasing data too early can compromise an ongoing trial. That’s because most clinical trials are double-blind to prevent bias and ensure the trial continues – for instance, if a patient discovers that they are receiving a placebo, they may stop taking the treatment correctly or be more ambivalent towards taking it, thereby affecting the results and even potentially jeopardising the trial.
But often, even when patient data can be safely returned, the reasons for long delays are not explained. This leads to frustration from the patients, and in some cases they become hesitant to participant in future trials.
A framework to guide the way
The FACILITATE project developed a white paper setting out a framework for returning patients’ data, in a way that builds trust and fosters collaboration, and benefits the patient without hindering the trials. FACILITATE championed a proactive approach, advising sponsors to proactively offer to return patient data via a process developed by the project.
Right now, the onus is on the patient to request their data from the companies running clinical trials. FACILITATE found that by offering patients the option to receive their data upfront, and explaining to them when and how they were going to receive it, this built trust amongst the trial participants. It also set expectations and explained the reasons for delays in return of data.
And building trust works both ways – Johanna Blom, FACILITATE’s project coordinator, explains that when patients have trust they tend to stay in the clinical trials for longer.
“A lot of people leave a trial because they don’t feel understood, they don’t feel heard. It might be burdensome, they have a lot of exams or visits, and at some point they just go,” she says.
“If you enhance trust, you have a higher recruitment rate and a lower attrition rate. People stay in the trial, even if it’s complicated, because they really feel you are working with them and for them.”
The starting point for developing the white paper was establishing ethical principles and the lawful basis for the return of clinical trial data under the EU’s General Data Protection Regulation (GDPR). FACILITATE analysed all the documents and peer-reviewed papers currently available and then held several discussions with different groups of stakeholders, including trial participants, researchers, sponsors, healthcare providers, and regulators to extract the final ethical principles, which include outlining the rights of individuals to their data as well as the needs for beneficence, non-maleficence, privacy, utility, public value, empowerment, data custodianship, justice, transparency and accountability.
Roadblocks to returning data
There are some types of data that are tricky to return because they require expert analysis. Genomic data was highlighted by FACILITATE as one of those areas where, in many EU countries, an expert interpretation is needed to accompany the data.
In addition, clinical trials are often experimental, and Blom emphasises that care must be taken when providing a participant with trial data to ensure that a patient doesn’t receive information about a particular outcome that is not yet a clinically validated result. The type of disease being studied also impacts what has to be taken into consideration.
“If you have neurodegenerative disorders, you have different responsibilities because people are looking at their quality of life. Whereas with vaccines, you normally test healthy people, so it’s different,” explains Blom.
Evaluate, adjust and bring it up to scale
GSK and Sanofi have launched pilots trialling how the framework works in practice within clinical trials, while several other companies have expressed interest in using the framework in upcoming trials.
“We will learn from these pilots,” says Blom. “Our motto is evaluate, adjust and then bring it up to scale. By the summer, we will have a toolbox to make it easier for companies to start using this framework.”
The toolbox will include logic models, tools to assist in constructing consent forms with quality control, tools to incorporate health literacy, and a list of what technical requirements are needed in order to start.
Reaching decision-makers
In December 2025, the FACILITATE project organised an event in the European Parliament to make European policymakers more aware of the project’s outcomes, hosted by MEP Vytenis Andriukaitis.
Blom says it’s important to make policymakers aware of this result because they can change the rules of clinical trials going forwards.
“If we want to be more transparent overall, then a return of participant data framework might become a part of regulation and good clinical practice. At the moment, it’s mandatory to have a lay summary. Why shouldn’t giving individual participant data back to those who gave access to it be mandatory too?”
She says that the time to strike is now, while the iron is hot.
“The genie is out of the bottle – it’s out, and now we have to use it.”
FACILITATE is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.