One of the most persistent myths about clinical trials is that participants are used as guinea pigs, subjected to untested drugs with no idea of what might happen.
This could not be further from the truth!
By the time a treatment reaches a clinical trial involving patients, it has already spent many years being studied in laboratories. Researchers examine how a drug behaves at a molecular level, by testing it on cell cultures or tissue samples (this is sometimes referred to as pre-clinical, literally before the clinic).
One example of this is FLF-funded CURE FL researcher Dr Pérez-Galán, who has developed in the lab two new kinds of CAR-T treatment. These novel CAR-Ts not only attack the cancer cells but also target the surrounding environment which keeps the tumour alive. Part of this exciting work is now moving through several regulatory steps, before it is approved as being safe and appropriate for use in humans (ie. to run a clinical trial).
After years of extensive preclinical studies prove successful, researchers apply for approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and equivalent bodies in countries around the world. These agencies only grant permission after reviewing all of the evidence and do not approve trials lightly.
On top of regulatory approval, every clinical trial must also receive independent ethical review. An ethics committee examines the trial design to make sure the potential benefits justify any risks, that participants will be fully informed, and that vulnerable people are protected. This committee includes clinicians, scientists, and members of the public who have no financial interest in the outcome.
Only once both regulatory and ethical approval are granted can a trial open.
Clinical trials are not a single leap into the unknown. They move through distinct phases, each building on the evidence gathered before and seeking approval at each stage.
The first question Phase I trials ask is: is this safe, and what dose is appropriate? A small number of volunteers receive gradually increasing doses. Researchers watch closely for side effects and work out how the drug is processed by the body.
Once a safe dosing range has been established, Phase II trials look at whether the treatment actually works against the specific disease. In FL research this might measure how long people are in remission for. Side effects continue to be carefully monitored throughout.
This is the large-scale confirmation phase. A new treatment is typically compared directly against the current standard of care. Phase III results are what regulatory agencies scrutinise most closely before granting a licence.
Participation in a clinical trial is entirely voluntary. Before you agree to anything, you will receive a detailed explanation of the study what it involves, its potential benefits, its known risks, and your right to withdraw at any time without it affecting your standard care. This process is called informed consent, and it is a legal and ethical requirement worldwide.
You will be monitored more closely than in routine care, with more frequent appointments and assessments. Many people find this level of attention reassuring. You will also have access to a specialist research team alongside your usual oncology team.
Sign up for our upcoming webinar ‘What no-one tells you about clinical trials and why it matters for your care’ on Tuesday 26th May 2026.
Explore more blog articles in our ‘busting the myths about clinical trials’ series.
