Tag Archive for: NIH

Should You Join a Clinical Trial?

Watch this video from the National Cancer Institute to learn some reasons you might want to join a cancer clinical trial. Like all treatment options, clinical trials have possible benefits and risks. By looking closely at all options, including clinical trials, you are taking an active role in a decision that affects your life.


Immunotherapy to Treat Cancer

Cancer immunotherapy clinical trials are critical to bringing new and potentially lifesaving treatments to more patients with more types of cancer.  Immunotherapy is a type of cancer treatment that helps your immune system fight cancer. The immune system helps your body fight infections and other diseases. It is made up of white blood cells and organs and tissues of the lymph system.

Immunotherapy is a type of biological therapy, a treatment that uses substances made from living organisms to treat cancer. >>Read more



Paying for Clinical Trials

As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient Care Costs

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance. They include:

  • Doctor visits
  • Hospital stays
  • Standard cancer treatments
  • Treatments to reduce or eliminate symptoms of cancer or side effects from treatment
  • Lab tests
  • X-rays and other imaging tests

Research Costs

Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include:

  • The study drug
  • Lab tests performed purely for research purposes
  • Additional x-rays and imaging tests performed solely for the trial

When you take part in a trial, you may have extra doctor visits that you would not have with standard treatment. During these visits your doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and child care.

From www.cancer.gov

What are the Phases of a Clinical Trial?

Clinical trials to test new cancer treatments involve a series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. During the early phases (phases 1 and 2), researchers figure out whether a new treatment is safe, what its side effects are, and the best dose of the new treatment. They also make sure that the treatment has some benefit, such as slowing tumor growth. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid.

There are also very early (phase 0) and later (phase 4) phase clinical trials. These trials are less common. Phase 0 trials are very small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness. They take place after a new treatment has been approved and is on the market.

The following shows the number of patients that take part and the purpose of the most common phases. Although the trial phases are explained in the context of drug treatment trials, the same concepts apply to most types of clinical trials.

Phase 1


  • To find a safe dose
  • To decide how the new treatment should be given (by mouth, in a vein, etc.)
  • To see how the new treatment affects the human body and fights cancer

Number of people taking part: 15–30

Phase 2


  • To determine if the new treatment has an effect on a certain cancer
  • To see how the new treatment affects the body and fights cancer

Number of people taking part: Less than 100

Phase 3


  • To compare the new treatment (or new use of a treatment) with the current standard treatment

Number of people taking part: From 100 to several thousand

Some researchers design trials that combine two phases (phase 1/2 or phase 2/3 trials) in a single protocol. In this combined design, there is a seamless transition between trial phases, which may allow research questions to be answered more quickly or with fewer patients.

From: www.cancer.gov

Patient Safety in Clinical Trials

Clinical trial participants are a vital part of cancer research, and patient safety is of utmost importance in the clinical trial process. There are federal rules in place to help ensure the safety and ethics of clinical trials. If you choose to take part in a clinical trial, you will be protected through:

  • The Informed Consent Process;
  • Careful review and approval of the clinical trial protocol by scientific experts and an institutional review board (IRB);
  • Ongoing monitoring of the trial by the IRB, Data and Safety Monitoring Boards (DSMBs) for phase 3 trial, the organization sponsoring the trial, and the research team.

For more about how your safety is protected on clinical trials, visit http://cancer.gov/patientsafety