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Introduction | Obstacles to Participation | Proposals | Ethics & Issues | Terminology | Toxicity
Links & Resources: Basics | Expanded Access | Patient Rights | Travel for treatment
If we do not increase participation in clinical trials, we can't hope to make progress in treating lymphomas. Seeking clinical trials might be particularly relevant to patients with incurable forms of lymphoma. However, it is a challenge to identify which clinical trial is in your best interest, and how to proceed.
"Previous research by UC Davis Cancer Center investigators, published in the March 13, 2001 issue of the Journal of Clinical Oncology, found that both doctors and patients sometimes hold misconceptions that can discourage enrollment in clinical trials.
In that study, more than a third of the doctors declined to refer patients to clinical trials, mistakenly believing that no trials were available or that their patients were too sick to be accepted. In reality, more than 150 clinical trials were available during the study period.
Moreover, a third of the patients who were considered for clinical trial participation declined to participate, many of them out of a mistaken belief that investigational treatments are not as effective as standard treatment.
In fact, many investigational treatments are at least as effective as conventional therapy, and cancer patients who participate in clinical trials frequently have higher survival rates than those who receive standard care. ~ UC Davis Cancer Center
1. Start by educating yourself about the disease: Find reputable sources of information on the Internet, and learn about standard and emerging treatments. Make contacts and join reputable support groups. Discuss what you are considering with others in your situation who may have direct experiences.
2. Ask questions of your treating physician ... (but don't stop there!) You should *not* feel disloyal about seeking clinical trial information, and you don't need your doctor's permission to do so.
For example: What investigational treatments have the potential to:
Also see: Clinical Trials: Questions to Ask Your Doctor Time
3. Obtain references to lymphoma experts with whom you can consult in your area. The Doctors section of this website contains help with this. It's important to seek consult with experts in the field who will not treat you. This helps to eliminate conscious or unconscious bias -- an investigator may want to fill a particular trial, for example.
4. Call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237); TTY at 1-800-332-8615. The call is free and a trained information specialist is available to answer your questions.
Resources on Toxicity and Reporting Adverse Events
"In CTCAE, Grade refers to the severity of adverse events. Generally,
Grade 1events are mild;
Grade 2 are moderate;
Grade 3 are severe;
Grade 4 are life-threatening or disabling;
Grade 5 is death.
CTCAE grading is by definition a 5- point scale generally corresponding to mild, moderate, severe, life-threatening and death. This grading system inherently places a value on the importance of places a value on the importance of an event, although, there is not necessarily "proportionality" among grades (a "2" is not necessarily twice as bad as a "1"). Some adverse events are difficult to "fit" into this 5 point schema, but altering the general guidelines of severity scaling would render the system useless for comparing results between trials, an important purpose of the system. Some AES do not have a value for every Grade (e.g., Grade 4 hiccups is blank). "
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Glossary of toxicity http://ctep.cancer.gov/forms/CTCAE_Glossary.pdf
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Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
http://ctep.cancer.gov/forms/CTCAEv3.pdf
http://ctep.cancer.gov/reporting/ctc.html
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ICH
www.fda.gov/cder/guidance/index.htm
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FDA
www.fda.gov/medwatch
www.fda.gov/cder/aers
www.fda.gov/oc/tfrm/riskmanagement.pdf
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