CARING AMBASSADORS

Empowering People to be Ambassadors of their Own Health Since 1997.

LUNG CANCER PROGRAM


Lung Cancer Clinical Trial Call to Action

The Caring Ambassadors Lung Cancer Program is teaming up with EmergingMed, a free online tool for cancer patients to find their best matches for clinical trials. This campaign is a collaborative effort designed to proactively involve lung cancer patients and their families in learning about and searching for clinical trials.

When you are diagnosed with lung cancer and need treatment, clinical trials may be an option for you. Choosing to join a clinical trial is something you, those close to you, and your doctors and nurses can decide together.

The Lung Cancer Clinical Trial Matching Service provides personalized education and matching to quickly identify clinical trial options that match each person’s specific diagnosis, stage, and treatment history.

If you would like to learn more about clinical trials for lung cancer, click below.

EmergingMed Call to Action

What is a Clinical Trial?

Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

Doctors all over the country are conducting many types of clinical trials. Clinical trials are designed to answer important questions and to find out whether new approaches are safe and effective.

The National Cancer Institute, drug companies, medical institutions, and other organizations sponsor clinical trials. Clinical trials take place in many settings, such as cancer centers, large medical centers, small hospitals, and doctors’ offices.

Research already has led to advances that have helped people live longer, and research continues. Researchers are studying methods of preventing lung cancer and ways to screen for it. They are also trying to find better ways to treat it.

Screening tests: Doctors are studying whether screening tests can detect lung cancer early and reduce a person’s chance of dying from it. The NCI is sponsoring large research studies of chest x-rays and spiral CT scans for lung cancer screening. So far, chest x-rays and spiral CT scans have not been shown to reduce a person’s chance of dying from lung cancer.

Treatment: Researchers are studying many types of treatment and their combinations.

  • Surgery: Surgeons are studying the removal of less lung tissue and using internal radiation therapy (brachytherapy) to kill cancer cells that remain.
  • Chemotherapy: Researchers are testing new anticancer drugs and new combinations of drugs. They’re also combining chemotherapy with radiation therapy.
  • Targeted therapy: Doctors are combining new targeted therapies with chemotherapy and radiation therapy.
  • Radiation therapy: Researchers are studying whether radiation therapy to the brain can prevent brain tumors from forming among people with nonsmall cell lung cancer.

If you’re interested in being part of a clinical trial, talk with your doctor. People who join clinical trials make an important contribution by helping doctors learn more about lung cancer and how to control it. Although clinical trials may pose some risks, researchers do all they can to protect their patients.

Educational information provided by The National Cancer Institute (NCI) Internet site.

Types of Clinical Trials

Types of Clinical Trials

phase I trial – This is the first clinical trial for studying an experimental drug or treatment in humans. Phase I trials are usually small (10-100 people) and are used to determine safety and the best dose for a drug. These trials provide information about side effects, and how the body absorbs and handles the drug. People in these trials usually have advanced disease and have already received the best available treatment.

phase II trial – Phase II trials examine whether a drug or therapy is active against the disease it is intended to treat. Side effects are studied. A phase II trial is a noncomparative study, meaning the therapeutic effects and side effects of the experimental treatment are not compared to another drug or a placebo.

phase III trial – Phase III trials are conducted to find out how well a drug or therapy works compared to standard treatment or no treatment. Phase III trials are large studies and usually involve several hundred to thousands of patients.

controlled clinical trial – A controlled clinical trial divides participants into study groups to determine the effectiveness and safety of a new treatment. One group receives the experimental treatment; the other group receives placebo (an inactive substance) or the standard therapy. This group is called the control group. Comparison of the experimental group with the control group is the basis of determining the safety and effectiveness of the new treatment.

randomized clinical trial – A randomized clinical trial involves patients who are randomly (by chance) assigned to receive either the experimental treatment or the control treatment (placebo or standard therapy).

Scientific Review Panels

This panel is made up of experts who review a clinical trial protocol before it starts accepting patients to make sure it is based on sound science. All clinical trials that are funded by the Government must go through this review. Many other clinical trial sponsors, such as drug companies, also seek expert advice on the scientific merit of their trial protocols.Most clinical trials have to go through different types of review that are designed to protect all people who take part. These reviews are conducted by scientific review panels, Institutional Review Boards (IRBs), and Data and Safety Monitoring Boards (DSMBs).

Institutional Review Boards

This board also reviews a clinical trial protocol before it starts accepting patients. The board members make sure the risks involved in the trial are reasonable when compared to the possible benefits. They also closely watch the ongoing progress of the trial from beginning to end.

Federal rules require that each IRB be made up of at least 5 people. One member must be from outside the institution running the trial. IRBs are usually made up of a mix of medical specialists and members of the community. Many include members from diverse careers and backgrounds. In most cases IRBs are located where the trial is to take place. Many institutions that carry out clinical trials have their own IRBs.

Data and Safety Monitoring Boards (DSMBs)

For phase III trials, DSMBs monitor the trial to help ensure your safety. They may also be appropriate and necessary for certain phase I and II clinical trials. A DSMB is an independent committee made up of statisticians, physicians, and other experts.

The Board must:

  • Ensure that any risks that come from being in the study are reduced as much as possible
  • Ensure that the data are sound
  • Stop a trial if safety concerns come up or as soon as its objectives have been met

Clinical Trials Follow Strict Guidelines

The guidelines that clinical trials follow clearly state who will be able to join the study and the treatment plan. Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which is like a recipe for conducting a clinical trial. The protocol explains what the trial will do, how the study will be carried out, and why each part of the study is necessary.

It includes information on:

  • The reason for doing the study
  • Who can join the study
  • How many people are needed for the study
  • Any drugs they will take, the dose, and how often
  • What medical tests they will have and how often
  • What information will be gathered about them

Who Can Join a Clinical Trial?

Based on the questions the research is trying to answer, each clinical trial protocol clearly states who can or cannot join the trial.

Common criteria for entering a trial:

  • Having a certain type or stage of cancer
  • Having received a certain kind of therapy in the past
  • Being in a certain age group

Criteria such as these help ensure that people in the trial are as alike as possible. This way doctors can be sure that the results are due to the treatment being studied and not other factors.

These criteria also help ensure:

  • Safety

Some people have health problems besides cancer that could be made worse by the treatments in a study. If you are interested in joining a trial, you will receive medical tests to be sure that you are not put at increased risk.

Accurate and meaningful study results

You may not be able to join some clinical trials if you already have had another kind of treatment for your cancer. Otherwise, doctors could not be sure whether your results were due to the treatment being studied or the earlier treatment.

Randomization

Randomization is a process used in some clinical trials to prevent bias. Bias occurs when a trial’s results are affected by human choices or other factors not related to the treatments being tested. Randomization helps ensure that unknown factors do not affect trial results.

In a randomized clinical trial, you will be assigned by chance to either a control group or an investigational group. Randomization is used in all phase III and some phase II trials. These trials are called randomized clinical trials. If you participate in such a trial, you will be assigned by chance to either an investigational group or a control group. Your assignment will be determined with a computer program or table of random numbers.

If you are assigned to the control group, you will get the most widely accepted treatment (standard treatment) for your cancer.

If you are assigned to the investigational group, you will get the new treatment being tested. Comparing these groups to each other often clearly shows which treatment is more effective or has fewer side effects. If you are thinking about joining a randomized clinical trial, you need to understand that you have an equal chance to be assigned to either one of the groups. The doctor does not choose the group for you.

Will I get a placebo?

A placebo is designed to look like the medicine being tested, but it is not active. Placebos are almost never used in cancer treatment trials. In some cases, a study may compare standard treatment plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo.

Patient Protection

Federal rules help ensure that clinical trials are run in an ethical manner. Your rights and safety are protected through: Careful review and approval of the clinical trial protocol by two review panels. These panels include:

  • A scientific review panel
  • An institutional review board (IRB)

Ongoing monitoring provided during the trial by:

  • The IRB
  • Data and Safety Monitoring Boards (DSMBs) for phase III trials
  • Your research team

Informed Consent

Informed consent is a process through which you learn the purpose, risks, and benefits of a clinical trial before deciding whether to join. It is a critical part of ensuring patient safety in research. During the informed consent process you learn important information about a clinical trial. This information can help you decide whether to join. The research team, which is made up of doctors and nurses, first explains the trial to you.

The team explains the trial’s:

  • Purpose
  • Procedures
  • Risks and benefits

They will also discuss your rights, including your right to:

  • Make a decision about participating
  • Leave the study at any time

If you decide to leave the study, your doctor will discuss other treatment options with you. Before agreeing to take part in a trial, you have the right to:

  • Learn about all your treatment options
  • Learn all that is involved in the trial – including all details about treatment, tests, and possible risks and benefits
  • Discuss the trial with the principal investigator and other members of the research team
  • Both hear and read the information in language you can understand

After discussing all aspects of the study with you, the team gives you an informed consent form to read. The form includes written details about the information that was discussed and also describes the privacy of your records. If you agree to take part in the study, you sign the form. Remember, even after you sign the consent form, you can leave the study at any time.

For more information please visit Clinical Trial Resources

Clinical Trial Resources

Cancer Clinical Trials Help 
The nonprofit, Coalition of Cancer Cooperative Groups, provides information and education about cancer clinical trials as well as a free, unbiased cancer clinical trial matching service, TrialCheck.

CenterWatch
Sponsored by Thomson publishing company, a searchable clinical trials database

Clinicaltrials.com
A service provided by Pharmaceutical Research Plus, Inc. (PRP), a company that helps increase enrollment in clinical trials; a searchable database by condition is available.

ClinicalTrials.gov
Federally supported site dedicated to listing U.S. government-funded clinical trials

EmergingMed.com
A clinical trial matching and referral service that is free to patients. The company is privately owned and is supported by monthly subscription fees from pharmaceutical and biotechnology companies to list and maintain their clinical trials EmerginMed’s database.

National Cancer Institute (NCI) Cancer.gov
Comprehensive information about cancer including types of cancer, prevention, treatment, clinical trials, supportive care, terminology resources, and cancer literature.

OncoLink
Extensive cancer resource site from the University of Pennsylvania Abramson
Cancer Center; includes information on types of cancer, treatment options, clinical trials, and coping with cancer.

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