How to join a clinical trial safely
Where to look, what to ask, and what your rights are.
Published 5 min read
Key points
- In the EU, a trial of a medicine can start only after an ethics review and approval by the authorities. Each one has an EU trial number you can look up.1
- You can leave a trial at any time, without giving a reason, and without it affecting your care.1,2
- Participants do not pay for the trial medicine or the tests the trial requires. Travel costs are usually reimbursed.1,3
Clinical trials become worth a look when antipsychotics have not helped enough, or when someone wants to explore other treatment options. Trials test medicines, but also medical devices, such as magnetic brain stimulation or apps, and talking therapies.4
The treating psychiatrist is the best first contact. They may know of trials nearby, and they can judge whether one suits you.2,5 If you join, they can stay in touch with the trial team about your care.4 In most trials, people keep seeing their own doctors, but some trials ask participants to stop or change medicines they take.6
To clarify with the psychiatrist before joining:
- whether the trial suits the diagnosis and the current treatment
- whether a medicine would have to stop or change, and whether that is safe6
- which treatment is available outside the trial2
- whether the psychiatrist stays involved during the trial4
Where to find trials
Anyone can search these public registers:
| Register | What it lists |
|---|---|
| Clinical Trials Information System (CTIS) (opens in a new tab) | Trials of medicines in the EU and the European Economic Area, from 20227 |
| ClinicalTrials.gov (opens in a new tab) | Trials worldwide, run by the US National Library of Medicine8 |
| WHO search portal (opens in a new tab) | Trials from registers in many countries, in one search9 |
| OMON (opens in a new tab) | All medical research in the Netherlands that is under official review10 |
Search for “schizophrenia” or “psychosis”, choose your country, and keep the trials that are recruiting. A register can be behind on whether a trial is still recruiting, so the trial team has the final word.10
How to tell a trial is genuine
A genuine trial:
- is in a public register before the first participant joins, with a number you can look up11
- has been reviewed by an ethics committee and approved by the authorities; in the EU, the information for participants gives its EU trial number1
- does not charge for the trial medicine or the tests the trial requires1
Being listed on ClinicalTrials.gov is not an approval: the US government does not review every study on it.8 European regulators have warned about clinics that sell experimental treatments outside an authorised trial, and advise a second opinion before any such treatment.12
Questions for the trial team
Write the questions down, and consider bringing a family member or friend.4
About the trial:
- what the trial tests, and who pays for it2
- whether a placebo is possible, how the treatment is assigned, and who will know which one it is14
- how long the trial lasts, and how often visits are needed14
About safety:
- how the possible risks and benefits compare with the current treatment14
- who looks after medical care during the trial14
- who to contact if there is a problem, and whether someone is available day and night2
- what happens if the trial treatment stops, or someone leaves early2
- what happens in case of harm14
About costs and afterwards:
- whether travel and other costs are reimbursed14
- whether the treatment can continue after the trial, if it helps14
- whether participants are told the results14
The Declaration of Helsinki, the international code for medical research, says arrangements should be made before a trial starts for participants who still need a treatment that proved helpful.11
Your rights
- Time to decide. You receive written information and enough time to think it over, and you can talk it through with family or your doctor.1,3
- Leaving. You can leave at any time, without giving a reason, and it does not affect your care.1,2 Information collected before you leave may still be used.1 Talk to the researcher first, as some medicines have to be reduced gradually.3
- Insurance. Every EU country must have a system that compensates harm caused by a trial.1 In the Netherlands, researchers insure participants free of charge, for harm caused by the research that is reported within four years.3
- Costs. Participants do not pay for the trial medicine or the tests the trial requires.1 Travel costs are usually reimbursed; payment for taking part is uncommon.3,13
- Privacy. Your data are recorded under a number instead of your name.3
- Results. A summary of the results in plain language is published, whatever the outcome.1
- Independent advice. In the Netherlands, an independent expert who is not part of the trial must be available to answer your questions.15
When someone is too unwell to decide
Severe psychosis can leave a person unable to decide about a trial.16 A legal representative must then give consent instead.1,3 Who that can be depends on the country. In the Netherlands, it is a guardian or mentor appointed by a court; if there is none, in this order: someone authorised in writing, the spouse or partner, the parents, adult children, then adult brothers and sisters.13
The person still receives the information in a way they can understand, and takes part in the decision as far as possible. If they show that they do not want to take part, or want to leave, that wish is respected.1,3
How to get in touch
The psychiatrist can contact the trial team for you. You can also contact the team yourself. Their details are on the trial’s page in these registers:4,5,10
A reply is not guaranteed. If none comes, the trial may have finished at that hospital, or the contact details may have changed.17 Another hospital in the same trial, or the sponsor, can help.
