EuropeUpdated 8 October 20268 min read

Referring a Patient Into a Clinical Trial: How to Read a Protocol Record

Written by the editorial team · fact-checked against primary sources.

On this page

  1. Where the records live
  2. The five fields that decide a referral
  3. What to tell the patient
  4. Pre-screening before you write to a site
  5. Sources

<!-- Clinician wave 2, article 3. Audience: GPs/psychiatrists. Published PENDING per 08.10 decision. -->

For a patient who has exhausted the funded options and cannot pay privately, a recruiting trial is often the only route to an investigational treatment, and it arrives with supervision and at no cost. The practical obstacle is rarely willingness; it is that protocol records are written for regulators, and the referral decision hides in five fields. This page is for clinicians doing that reading. It is an informational summary, not clinical guidance: whether trial participation suits this patient remains your judgement and, finally, the investigator's. The patient-facing version is our clinical trials guide; the clinician hub, with the current table of recruiting studies by country, is here.

TL;DR Read a record in this order: recruitment status, then sites and contacts, then eligibility criteria, then design, then primary endpoint. Pre-check age, indication and failed-treatment count from your own notes, or have the patient run the two-minute structured pre-screen. Contact the site directly, because listings lag. Prepare the patient for three facts: most applicants are screened out, assignment may be to placebo, and they can leave at any time without losing regular care.

Where the records live

Two registries cover Europe. ClinicalTrials.gov is the largest and usually the most readable: filter by condition, intervention, recruitment status and country, and each study carries an NCT number. CTIS, the EU Clinical Trials Information System, is the EU's official register and the legally authoritative one for trials conducted under the EU Clinical Trials Regulation; its public portal is less comfortable to read but carries the authorised protocol versions and the per-country site lists. Many studies appear in both; when details disagree, treat the site contact as the source of truth, because both registries lag reality in both directions. A site listed as recruiting may have filled its slots or paused; conversely, new sites are sometimes active before the record updates.

The five fields that decide a referral

Recruitment status, first. "Recruiting" at study level does not mean every site is open; CTIS and ClinicalTrials.gov both carry per-site status lines, and those are the ones to read. "Not yet recruiting" with a listed contact is worth an email for a patient who can wait; "active, not recruiting" means the window has closed.

Sites and contacts, second. The question is not whether the study exists but whether a reachable site exists within the patient's travel tolerance, since dosing studies typically require multiple visits over weeks to months. Records list a central contact and site-level contacts; the site-level one answers faster.

Eligibility criteria, third. Inclusion and exclusion lists run long, but three criteria decide most cases and are checkable from your own notes: age range; the protocol's definition of the indication (treatment-resistant depression protocols typically specify a current moderate-to-severe episode and a minimum count of adequate antidepressant trials failed within it, most commonly two, and some protocols also cap the number); and the exclusions that recur across the whole field, psychotic disorders in history, significant suicide risk at screening by the protocol's own scale, unstable cardiovascular disease, pregnancy, and active substance use disorder. The structured medication history of the current episode (substance, maximum dose reached, weeks at that dose, measured outcome, reason for stopping) is the same document that drives an esketamine application, and preparing it once serves both routes.

Design, fourth. The arms table tells the patient what they are actually agreeing to: how many arms, what the randomisation ratio is (a 2:1 ratio means a one-in-three chance of placebo, and saying it that way lands better than the ratio), whether blinding applies, and whether an open-label extension exists, since the possibility of guaranteed active treatment after the blinded phase changes many patients' calculus.

Primary endpoint and duration, fifth. The endpoint tells you what the study measures and when (typically a symptom-scale change at a fixed week), which in turn tells the patient how long the committed period is, what the visit burden looks like, and when they will know anything. Follow-up phases often run months beyond dosing.

What to tell the patient

Three facts, best delivered at referral rather than discovered at the site. Most applicants are screened out: the funnel from first contact to randomisation loses the majority, for protocol reasons (a criterion missed, a concomitant medication, a score outside the window) that are not a judgement on the patient or on your referral, and a screen-failure at one study says nothing about the next. Assignment may be to placebo or an active comparator, by chance and usually blinded, and participation only makes sense for a patient who can accept that proposition for the study's duration. And participation is voluntary throughout: consent can be withdrawn at any time, without reasons and without any effect on regular care, which continues in parallel and remains yours.

Two practical points complete the picture. Trials are free, with travel costs reimbursed by many sponsors but not all, and modest compensation existing in some protocols; and washout, where a protocol requires tapering current medication, is a clinical decision made with the investigator in which the referring clinician should stay involved, not a formality the patient signs alone.

Pre-screening before you write to a site

We maintain structured entry criteria for the recruiting European studies in our directory, adjudicated from the protocol records: indication, age window, failed-treatment requirements, per-country sites. Your patient can check themselves against them in about two minutes via the eligibility check, trial route, and the result is a shortlist of studies whose hard criteria they do not visibly fail, with the site list for their country. It is a pre-screen on registry data, not an eligibility decision: the investigator's screening visit always makes the final call, and our data inherits the registries' lag. The current snapshot of recruiting studies by country also sits as a table on the clinician hub.

Who is actually recruiting changes quarter to quarter; in 2026 the active psychedelic and adjacent sponsors with European sites include atai/Beckley (BPL-003), GH Research and MindMed, alongside investigator-initiated studies in national systems; Compass Pathways' Phase 3 psilocybin programme has completed recruitment (CTIS status: recruitment ended) and is in the readout and filing phase, so it is no longer a referral destination. The per-study detail belongs to the registries, not to a static page, which is why this guide teaches the reading rather than listing the studies.

Sources

  1. ClinicalTrials.gov
  2. EU Clinical Trials Information System (CTIS)
  3. EU Clinical Trials Regulation 536/2014
  4. ICH GCP E6: informed consent and withdrawal

Continue reading

Looking for a provider? Browse the directory by country or read how listings are verified.