NCI Health Information Tip Sheet for Writers:
Clinical Trials Awareness
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TOPIC: Clinical Trials Awareness
WHAT'S THE PROBLEM?
Clinical trials are research studies conducted with people who volunteer to take part in a study to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of, and progress toward controlling -- and potentially curing-- cancer. They also receive innovative care from experts. However, enrollment in adult clinical trials is very low compared to the number of eligible participants -- if greater numbers of adults with cancer enrolled in trials, greater knowledge about possible beneficial treatments could be discovered more rapidly. One reason for low enrollment may be that much of the publicity surrounding clinical trials focuses on the drawbacks or possible negative outcomes from the trials. These drawbacks include the fact that: new drugs or procedures under study are not always better than the standard care to which they are being compared; participants in randomized trials are not able to choose the approach they receive (or in rare instances where no standard of care exists they may be given a placebo); and participants may be required to make more visits to the doctor than they would if they were not in the clinical trial.
WHO COULD BENEFIT FROM CANCER CLINICAL TRIALS?
The benefits of participating in a clinical trial include:
- Participants have access to promising new approaches that are often not available outside the clinical trial setting.
- The approach or drug being studied may be more effective than the standard approach and they often build on standard therapies by adding new treatments or substituting newer treatments for one component of an older therapy.
- Participants receive thorough medical attention from a research team that includes doctors and other health professionals. They will have fully informed consent before any care is administered.
- Participants may be the first to benefit from the new method or drug under study.
- Results from the study may help others in the future, including relatives at risk.
CAN THE PUBLIC BENEFIT FROM CLINICAL TRIALS?
The results of clinical trials are often published in peer-reviewed, scientific journals. Peer review is a process by which experts review the report before it is published to make sure the analysis and conclusions are sound. If the results are particularly important, they may be featured by the media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice.
BOTTOM LINE
Scientists are committed to increasing enrollment and awareness of cancer clinical trials. Enrollment in cancer trials among people under age18 is nearly 50 percent of eligible people with cancer, which is far better than enrollment of adults with cancer. Partly because of this successful enrollment, childhood cancer survival rates have been increasing over the past several decades. A 50 percent enrollment rate for adult cancer clinical trials would give a huge boost to research efforts and potentially speed many new treatments to patients fighting cancer. Also, given the unequal burden that some cancers have on minorities, increasing enrollment in these populations is highly desirable in order to reduce cancer health disparities.
CASE EXAMPLE(S)
- Miguel was diagnosed with a somewhat uncommon form of leukemia called chronic myelogenous leukemia (CML). His leukemia continued to worsen and all of the FDA approved treatments for CML failed to stop Miguel's leukemia from getting worse. After searching the internet, Miguel found out about a cancer clinical trial for patients with CML who had failed conventional treatments. Even though it meant going to a clinic several times a week, Miguel thought that the new drug being tested in this trial was his last chance. As it turned out, the new drug, called Gleevec, caused complete remission of Miguel's leukemia and halted the progression of the disease in others (but not everyone) in the trial. Miguel would not have had access to Gleevec if he had not enrolled in the trial and might not be alive today.
- Mark is a former smoker and even though he's now 70 years old, he's never had a problem with his lungs or with breathing until this week. Today he coughed up some blood and was worried enough that he rushed to his local emergency room. The ER doctors told him they could not make a diagnosis without examining his lung by either x-ray or spiral CT scan. Mark was unwilling to have the procedure done in the ER, so the doctor told him about a clinical trial called the National Lung Screening Trial (NLST) which he could enroll in for free that would perform one of these tests for him. The doctor told him that it was important that he find out what was going on in his lungs, because when detected by symptoms such as spitting up blood, lung cancer has usually spread outside the lung in 15 percent to 30 percent of cases. Spiral CT can pick up tumors well under 1 centimeter in size, while chest X-rays detect tumors about 1 to 2 cm in size. By participating in the NLST, not only will Mark find out more about what is wrong with his lungs, he will also help researchers determine which test can save more lives.
MORE INFORMATION
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