Research and new methods

Risk and possible benefit

In a trial, a new treatment may turn out better than, the same as or worse than standard care; that is exactly what the trial finds out. Before joining it is important to know both sides clearly.

Last updated: ~1 min read
A brass balance scale on a dark desk
Figure 1.Scales: risk and benefit

01Short answer

Possible benefits are early access to a new treatment, closer monitoring and helping future patients. Possible risks are unknown side effects, the treatment not working, extra tests and visits, and the chance of being in a placebo group (standard treatment is usually given as well in that case). Ethics committees and independent data monitoring boards oversee safety.

02Simple explanation

The result is unknown.

Benefit is possible.

So are risks.

Independent oversight.

03Scientific explanation

NCI: the safety of clinical trial participants is protected at several levels.

NCI: new treatments are tested step by step, from the laboratory to clinical trials; only those proven safe and beneficial become standard care.

04What happens in the body?

What to ask

What are the main risks and alternatives for me?

Two roads
Figure 2.Two roads — Risk and possible benefit

Oversight

An ethics committee and an independent board.

A safety net
Figure 3.A safety net — Risk and possible benefit

How to read the news

Research news brings hope, but not every advance suits everyone. Look at who it was tested in, at what phase and in how many people.

Talk to your doctor

Show your doctor what you have read; they will explain how it relates to your diagnosis and treatment. Do not change your treatment on your own.

05From research news to a conversation: four steps

Read, check, ask, decide together.

Read — From a trusted source.1ReadFrom a trusted source.
Check — Phase, participants, result.2CheckPhase, participants, result.
Ask — Show your doctor.3AskShow your doctor.
Decide — Together, without rushing.4DecideTogether, without rushing.
SourceA trusted site.
DoctorA personal explanation.
SafetyNot changing treatment yourself.

06Key points at a glance

TopicIn brief
What to askWhat are the main risks and alternatives for me?
OversightAn ethics committee and an independent board.
How to read the newsResearch news brings hope, but not every advance suits everyone. Look at who it was tested in, at what phase and in how many people.
Talk to your doctorShow your doctor what you have read; they will explain how it relates to your diagnosis and treatment. Do not change your treatment on your own.

07Key terms

Ethics committee
A group that approves and oversees a trial.
DSMB
Data and safety monitoring board.
Clinical trial
Testing a new treatment with volunteers.
Evidence
A result confirmed by reliable research.

08Key points

  • Learn.
  • Ask your doctor.
  • Write it down.
  • Check the source.
  • Talk to your doctor.

09Frequently asked questions

Is a trial riskier than standard care?

Sometimes the risks are less well known; compare with your doctor.

Will I get a placebo?

In most leukaemia trials everyone receives active treatment; ask.

Is this advance right for me?

Only your treating doctor can say, based on your diagnosis, stage and condition.

10Questions for your doctor

Take these questions to your appointment. The ones you save are collected on the “My questions” page and stay on this device only.

  1. Is a trial riskier than standard care?

  2. Will I get a placebo?

  3. Is this advance right for me?

My questions

12Sources

  1. National Cancer Institute. Patient Safety in Clinical Trials
  2. National Cancer Institute. What Are Clinical Trials?
  3. National Cancer Institute. Informed Consent in Clinical Trials
  4. National Cancer Institute. Phases of Clinical Trials
  5. National Cancer Institute. Using Trusted Resources
  6. World Health Organization (WHO). International Clinical Trials Registry Platform (ICTRP)
  7. National Cancer Institute. NCI Dictionary of Cancer Terms: phase I clinical trial
  8. National Cancer Institute. NCI Dictionary of Cancer Terms: phase II clinical trial
  9. National Cancer Institute. NCI Dictionary of Cancer Terms: phase III clinical trial
  10. National Cancer Institute. NCI Dictionary of Cancer Terms: phase IV clinical trial
Medical disclaimerThis information is for educational purposes only and does not replace medical advice.
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