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Research and new methods

From the lab to the patient: a long and careful road

A new treatment idea is usually born in the laboratory, but it goes through many checks before it reaches patients. Most candidates drop out along the way, and that is good for safety.

Last updated: ~1 min read
A bridge
Figure 1.A bridge — From the lab to the patient: a long and careful road

01Short answer

First, scientists find a weak spot in the cancer cell. Then, from thousands of substances, a candidate that acts on it is chosen and tested in cells and then in animal models (the preclinical stage). If the results are promising and the safety data acceptable, clinical trials begin with the regulator's approval: phases I, II and III. If successful, the medicine is approved and then monitored in phase IV. This road often takes more than ten years.

02Simple explanation

Find a target.

Preclinical testing.

Clinical phases.

Approval and monitoring.

03Scientific explanation

FDA: drug development includes discovery, preclinical research, clinical research, regulatory review and post-market safety monitoring.

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?

Translational research

The field that carries laboratory discoveries into the clinic.

Cell culture flasks stacked on the shelves of a laboratory cabinet
Figure 2.Cell cultures in the laboratory

Attrition

Most candidates stop because of safety or effectiveness.

A funnel
Figure 3.A funnel — From the lab to the patient: a long and careful road

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
Translational researchThe field that carries laboratory discoveries into the clinic.
AttritionMost candidates stop because of safety or effectiveness.
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

Preclinical
Research before testing in people.
Candidate drug
A new substance being tested.
Clinical trial
Testing a new treatment with volunteers.
Evidence
A result confirmed by reliable research.

08Key points

  • Find.
  • Test.
  • Monitor.
  • Check the source.
  • Talk to your doctor.

09Frequently asked questions

Why does it take so long?

Each stage checks safety and benefit.

Does everything that works in the lab work in people?

No, most does not; that is why clinical trials are needed.

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. Why does it take so long?

  2. Does everything that works in the lab work in people?

  3. Is this advance right for me?

My questions

12Sources

  1. U.S. Food and Drug Administration. The Drug Development Process
  2. National Cancer Institute. NCI Dictionary of Cancer Terms: preclinical study
  3. National Cancer Institute. What Are Clinical Trials?
  4. National Cancer Institute. Phases of Clinical Trials
  5. National Cancer Institute. Using Trusted Resources
  6. European Medicines Agency. Clinical trials in human medicines
  7. National Cancer Institute. Informed Consent in Clinical Trials
  8. National Cancer Institute. NCI Dictionary of Cancer Terms: clinical trial
  9. National Cancer Institute (NCI). Paying for Clinical Trials
  10. National Cancer Institute (NCI). Find NCI-Supported Clinical Trials
Medical disclaimerThis information is for educational purposes only and does not replace medical advice.
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