What a clinical trial is (and is not)
It is how medicine checks whether a new treatment is better, equal or worse than the existing one. Every drug used in colon cancer today (oxaliplatin, bevacizumab, pembrolizumab, encorafenib…) arrived through trials. You are not a "guinea pig": before reaching patients a drug has gone through years of laboratory work, and the trial is approved by the Spanish Medicines Agency (AEMPS) and an independent ethics committee.
The phases
- Phase 1: few patients; finds the safe dose. Usually offered when standard treatments have been exhausted. Many phase 1 trials today involve drugs aimed at a specific mutation (KRAS G12D, HER2…) and can produce meaningful responses.
- Phase 2: dozens or hundreds of patients; measures whether the drug works in that tumour.
- Phase 3: hundreds or thousands; compares the new treatment with the standard. This is the one that leads to approval.
What you should know
- Placebo: in oncology, placebo is almost never given instead of treatment. If there is a placebo, it is added to standard treatment (everyone receives at least the best available).
- Randomisation: in phase 3, a draw decides whether you receive the new treatment or the standard. Neither your doctor nor you choose.
- Cost: the drug, the extra tests and sometimes travel are paid for by the sponsor. You never have to pay.
- Voluntary: you sign an informed consent after reading it calmly, and you can withdraw whenever you want without it affecting your care.
- Closer monitoring: you will have more visits, blood tests and CT scans than outside the trial. For many patients that is an advantage.
- Eligibility criteria: each trial requires certain conditions (mutation type, previous lines, general health, liver and kidney function). Not meeting them is not a failure on your part; that trial is simply not for you.
How to find one
- Ask your oncologist, always. They know the trials open at your hospital and can refer you to another centre. Ask specifically: "Is there any trial for my mutation/situation, here or at another hospital?"
- Search yourself so you arrive at the appointment informed:
- Our guided trial finder filters trials recruiting in Spain by mutation, stage and province.
- The Spanish Clinical Studies Registry (REEC) of the AEMPS is the official registry in Spain.
- ClinicalTrials.gov is the international registry.
- Have your molecular profile to hand (RAS, BRAF, MSI, HER2, NGS panel). It is what decides most new trials. If you have not had a broad panel and have exhausted lines of treatment, ask for one.
- Contact the centre: each trial record lists the hospital and sometimes a contact. Usually your oncologist makes the referral. If you go on your own, bring reports and images.
What to ask before accepting
- What is being compared, and what is my chance of receiving the new treatment?
- What is the trial's aim (cure, extend life, improve symptoms)?
- What side effects of the new drug are known?
- How many extra visits and tests will there be, and where?
- What happens if the treatment stops working or I want to leave?
- Can I keep receiving the drug after the trial ends if it is working for me?