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What Is a Clinical Trial?

Researchers conduct clinical trials to try to learn if an investigational new drug works and is safe in people so that it can be reviewed by regulatory authorities for possible approval.

 

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Clinical Trial Phases

It takes a lot of research to develop a new drug treatment, including those in oncology. Clinical trials are done in several steps, also called “phases.” Each phase has a specific purpose. The phases are designed to answer certain questions about the investigational drug being tested while aiming to keep the patients in each trial as safe as possible.

icon 1 Preclinical Research

Researchers study investigational drugs in a laboratory before studying them in people. This type of research study is called a "preclinical trial."

The goal is to collect information and learn how the investigational drug works. Then, researchers must obtain permission from the government and other independent groups to begin a clinical trial in people. Preclinical trials are required before the investigational drug can be studied in people.

Phase1 Phase 1

Phase 1 clinical trials are the first step after the preclinical trials and are usually the first time a new investigational drug is studied in people.

A phase 1 clinical trial tests the drug in a small group of people (usually 20 to 100 patients).

Researchers design phase 1 clinical trials to learn:

  • What the investigational drug's serious unwanted adverse effects are
  • The dose and schedule that can be given to patients
  • How the investigational drug is absorbed and processed in the body
Phase 2 Phase 2

Phase 2 clinical trials assess how well the investigational drug is working in people who are diagnosed with a disease or condition.

Phase 2 clinical trials usually include up to several hundred patients.

Researchers design phase 2 clinical trials to:

  • Learn if the investigational drug may work in people who have a certain disease or condition 
  • Continue to learn about which dose of the investigational drug works

Phase 3 Phase 3

If the results of phase 1 and phase 2 clinical trials are positive, the investigational drug is studied in a larger number of patients with the disease or condition.

Phase 3 clinical trials usually include 300 to 3000 patients.

Researchers design phase 3 clinical trials to:

  • Confirm the adverse effects and the results seen in earlier phases
  • Learn how well the investigational drug works compared with another drug or compared with a placebo (no drug)
Phase4 Phase 4

Phase 4 clinical trials are conducted after the investigational drug is approved by regulatory authorities. These clinical trials may take place over many years and usually involve several thousands of patients.

Researchers design phase 4 clinical trials to:

  • Learn how a new drug works when people are taking it as part of their everyday lives
  • Identify and evaluate the long-term effects of a new drug over a long period of time in a greater number of patients

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More About Certain Terms

Advanced disease

Advanced disease means that the cancer has spread to a nearby tissue, a lymph node, or another part of the body.

DNA damage response (DDR)

The DDR is a complex network of surveillance and signaling in the cell that works to keep the DNA (genetic material) intact. It senses DNA damage, activates proteins that repair DNA, and assembles repair machinery. It also stops the cell’s life cycle to allow enough time for DNA damage to be repaired or causes the cell to die if DNA damage cannot be repaired. The most studied proteins involved in the DDR processes are ATM protein kinase, ATR protein kinase, and DNA-PK. These proteins help keep cells alive, so by stopping the action of these proteins, it may be possible to stop the cancer from growing and dividing.

Genomic integrity

A mechanism of every organism to maintain and accurately transmit genetic material from generation to generation or from one cell to another.

Placebo

An inactive substance or drug that looks the same and is given the same way as an active drug or treatment being tested. The effects of the active drug or treatment are compared with the effects of the placebo.

Relapsed disease

The return of a disease or the symptoms of a disease after a period of improvement.

Solid tumors

An abnormal mass of tissue, excluding those derived from blood-generating tissues. Although solid tumors may not be cancerous (malignant), in DDRiver™ studies, only malignant cancerous solid tumors are included. Different types of solid tumors are named for the type of cells that form them. The DDRiver™ clinical trials are not designed to assess tumors occurring only in a specific part of the body.

Unresectable cancer

Cancer that cannot be removed by surgery.