Take action

No placebo.
Don't lose a single minute.

In a disease where survival is measured in months, no one should gamble their time on a lottery. We are not asking anyone to reject science: we are asking to know, choose and demand ethical designs.

00 — Sign first

Sign the manifesto

You do not need to read the whole page to sign. This is what you are signing — six lines. Everything below explains why, point by point.

I sign because in a disease where survival is measured in months, a person’s time cannot be gambled on a lottery.

I call on the AEMPS, the EMA and the health administrations to require, in glioblastoma clinical trials:

  1. No pure placebo arm in short-survival diseases: always compare against the best available treatment.
  2. Guaranteed crossover to the active drug on first documented progression.
  3. Transparency of results and post-trial access to the treatment that worked.

We are not asking anyone to reject science. We are asking that it be designed to save lives.

Required in Spain: the collective petition is filed by health region.

Only the number, never a photo or copy. It is not required to sign: we ask for it only from those who wish to appear in the collective petition submitted to the AEMPS and the Spanish health administrations, where each signatory must be identifiable. If you leave it blank, your signature counts the same.

Your signature is recorded directly at info@aegbm.org. You can withdraw it at any time by writing to that address.

01 — The starting point

Time is treatment

In glioblastoma, every week counts. That is why the first step is not to accept a single protocol: it is to demand a schedule — full molecular diagnosis, tumour board and referral to a reference centre — without delays.

Molecular diagnosis

A full tumour profile (NGS) with no waiting: it is what opens the door to targeted therapy.

Tumour board

Have your case reviewed by a molecular board that matches the profile with the best option or trial.

Reference centre

Being treated where the experience is changes the prognosis. It is a right: second opinion and referral.

02 — The grounds

Why a pure placebo is not indispensable

This is not an opinion: international medical ethics already limits the use of placebo, and science already has designs that do not require giving up treatment.

Declaration of Helsinki (art. 33)
Placebo is only acceptable when no proven intervention exists, or for compelling methodological reasons and with no risk of serious or irreversible harm to the patient.
Adaptive designs without a pure placebo
Platforms such as GBM AGILE test several drugs at once with a shared control arm. The alternative to placebo already exists.
Right to truthful information (Spanish Law 41/2002)
You have the right to genuine informed consent: to know whether there is a placebo arm, in what ratio, and what happens if the tumour progresses.

Twenty years comparing against the same thing

Temozolomide (Temodal) became the standard in 2005 with the Stupp protocol. Since then, more than two decades of data confirm a median survival of roughly 15 months. That statistic is more than proven: it needs no further trials to validate it.

More than that: in patients with an unmethylated MGMT promoter — close to 60 % of cases — temozolomide is known to have minimal or no benefit. Assigning these patients to a control arm of temozolomide alone is not offering a treatment: it is assigning them something the evidence has already shown does not work for their molecular profile.

And yet, in 2026, many clinical trials still assign patients to a control arm of temozolomide alone — or worse, placebo — as if we did not know it is insufficient. That raises an uncomfortable question: is the patient being protected, or the study design?

For a person with glioblastoma, every treatment cycle is a window closing. Assigning them a drug whose limitations have been known for twenty years, instead of giving access to an investigational therapy, is not a neutral scientific control: it is a lost opportunity that the law itself seeks to prevent.

  • Spanish Law 14/2007 on Biomedical Research — requires that taking part in a trial does not cause disproportionate harm when alternatives exist.
  • EU Regulation 536/2014 — requires the trial design to minimise suffering and respect the principle of beneficence.
  • Declaration of Helsinki, art. 33 — placebo is only admissible where no proven treatment exists; where one does, the comparison must be against the best available, not the oldest.

Our position is clear: trials must compare against the best that exists today, not against the only thing that existed twenty years ago. And when the control arm condemns the patient to a treatment we know is insufficient, the design stops being ethical and becomes a sentence in disguise.

Trials must be designed to save lives, not to optimise commercial results

Only 8 % to 11 % of patients with newly diagnosed glioblastoma take part in a clinical trial. The main reason is not lack of willingness: it is the eligibility criteria, often so restrictive that they exclude most real patients.

Why does this happen? Because the criteria are, in most cases, written by the pharmaceutical company sponsoring the trial. Its natural incentive is to select the healthiest patients with the best prognosis — what a Fred Hutch Cancer Center researcher called “cancer olympians” — because they produce better statistics. The drug then looks better to the regulator, even if it does not work as well in the real population.

In glioblastoma, this has devastating consequences:

  • Criteria copied from trial to trial with no scientific justification. ASCO and Friends of Cancer Research have documented that many exclusion requirements are carried over by inertia, unrelated to patient safety or drug efficacy.
  • Molecular profiles used as a commercial filter. Selecting only patients with a favourable biomarker can make scientific sense, but when it is done systematically to inflate the response rate, everyone else is abandoned — precisely those who most need new options, such as patients with unmethylated MGMT.
  • Real patients who do not fit the “ideal patient”. Older age, previous treatments, comorbidities or slightly reduced performance status are enough to be left out. But those are the real patients, and they deserve access to research as much as anyone.

The FDA, the EMA and ASCO itself have formally recognised that eligibility criteria must be broadened. The European clinical trials regulation (EU 536/2014) requires the study design to minimise suffering and maximise potential benefit for participants.

What we ask is simple: that a trial’s criteria be designed to save lives, not to protect a commercial result. That the priority be to include the people who need options, not to exclude them because they do not fit an ideal profile that maximises return on investment.

03 — Our demands

What we demand

  1. 1
    No pure placebo in diseases with short survival. Always compare against the best available treatment, with active or adaptive designs.
  2. 2
    Mandatory crossover. On first progression, immediate switch to the active drug for anyone in the control arm.
  3. 3
    Transparency and post-trial access. Public results and continuity of the treatment that worked once the study ends.
04 — Tools that really exist

Your real options

We promise no miracles and guarantee no lawsuits. We give you the levers the law does recognise — and the reason behind each one.

Read your consent form

Randomisation ratio, what happens if the tumour progresses, whether there is crossover. You have the right to understand it before signing.

Compassionate and off-label use

Spanish RD 1015/2009 allows access to investigational or off-label drugs when justified and no alternative exists. You can apply — and appeal if refused on cost grounds alone.

Your oncologist’s report

It is the key piece. If the public-system oncologist will not sign it, an external neuro-oncologist can act as an expert backing the request.

Genomic profile of the tumour

It gives a scientific basis for targeted therapy. Without the molecular map there is no argument; with it, there is.

Emergency interim measures (art. 135 LJCA)

The urgent judicial route. It exists, but it is hard and needs a health-law solicitor: we present it honestly, not as a safe shortcut.

Deadlines and paperwork

Request your full medical record now. Watch the limitation period for a compensation claim: keep everything and log every date.

05 — Now you know why

You have read it all. Now sign it.

The more voices, the more weight the petition carries before the AEMPS, the EMA and the health administrations. Add yours.

Firm, but responsible. This page is advocacy and public information, not medical or legal advice. In glioblastoma, taking part in a serious trial is often a good option: our motto is get informed and demand, not refuse. Always consult your medical team and a solicitor specialising in health law.

What this rests on

Ethical and legal grounds

Last reviewed: June 2026. We recommend a health-law specialist review this section before final publication.