When patients give their samples to science, who gets to use them?
GRASP leaders co-authored a recent call to action in JAMA Oncology, that argues the clinical data and tumor samples patients donate during breast cancer trials are being underused, and lays out how academia, industry, and patients can fix it together.
Every year, thousands of people with breast cancer enroll in clinical trials. Along with their time and their trust, many give something else: tissue and blood samples, collected sometimes at multiple points during treatment.
These collections aren’t necessarily easy. They can mean additional blood draws, biopsies, and procedures at a time when patients are already going through cancer treatment. Patients agree to them because they believe their samples will advance science, helping researchers figure out which treatments work, for whom, and why.
A group of 53 breast cancer researchers and patient advocates says that promise is too often going unfulfilled. In a Special Communication published in JAMA Oncology, the authors show that the samples and data collected in registrational trials, the pivotal studies that lead to a new drug’s approval, are rarely used afterward to answer the question that matters most to patients: who actually benefits?
GRASP is proud to have contributed to this work. Co-founders Christine Hodgdon and Julia Maués are among the co-authors, part of an international coalition of investigators, data scientists, legal experts, and patient representatives calling for a better system.
Patients gave these samples. Are we making the most of them?
The team looked at the 29 trials that led to a new breast cancer drug approval in the U.S. between 2017 and 2024. Nearly all of them asked patients for tissue or blood samples.
But that material rarely went on to sharpen the picture of who benefits. Only 20 of the trials published a biomarker analysis, most looking at a single marker, and not one led to a change in how a drug was used or narrowed its use to the patients most likely to respond.
Why does that matter? When there’s no reliable way to spot the true responders, a drug gets approved for everyone in the study, even though, as first author Prof. Hans Wildiers points out, sometimes only 5 to 10 percent truly benefit. The rest can face the side effects and the cost without the reward.
A big part of the problem is access. The data and samples are usually controlled by the company that ran the trial, and independent researchers often can’t get to them.
And sometimes, the samples disappear altogether.
In one case the authors highlight, more than 80,000 samples that patients had donated were destroyed after a trial didn’t meet its main goal.
This isn’t a reason to step back. It’s a reason to fix the system.
We want to be clear about something. None of this is a reason to hesitate about joining a trial or giving a sample.
Clinical trials save lives, and the patients who take part are the reason breast cancer treatment keeps getting better. The point of this paper isn’t to discourage anyone from participating. It’s to make sure that patients’ altruism and willingness to contribute to research have the greatest possible impact.
“Of course we want patients to continue participating in clinical trials: these ensure that their chance of survival or recovery increases. But a lot of patients don’t realise that their doctors do not have access to their tumour samples or data from clinical studies. We need to make this more transparent and organise it better.” — Prof. Christine Desmedt, KU Leuven, senior author
That transparency matters. If patients are being asked to contribute their tissue, blood, and data to research, they deserve to understand how those contributions can be used, who will have access to them, and what will happen when the trial is over.
A better way forward
The authors don’t just name the problem. They offer solutions: give patients and academic researchers a real voice in how trials are designed; make consent forms clear that samples and data will be shared for future research; share de-identified trial data after approval; and give academic teams a chance to rescue biobanks before they’re thrown away.
At the heart of these recommendations is a simple idea: when patients give something of themselves to advance cancer research, we should do everything we can to make that contribution count.
This is exactly what GRASP exists to do: bring researchers and advocates to the same table as genuine partners. Patients shouldn’t just provide the samples that make research possible. They should have a voice in the systems that determine what happens to those samples and how they are used.
That patients helped write a paper now headed for discussion with the EMA, the FDA, and industry is the kind of seat at the table this work is all about.
Wildiers H, Adam V, O’Reilly S, et al. “Enhancing Clinical Cancer Research Through Sharing of Data and Biospecimens.” JAMA Oncology, December 18, 2025. Read the full paper here.
