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Clinical Trials > About Trials

Last update: Early version 

Introduction | Obstacles to Participation | Proposals | Ethics & Issues | TerminologyToxicity
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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:

  • improve my survival chances?

  • manage my disease without precluding the use of standard or emerging treatments.

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). "

Obstacles to Participation in Clinical Trials

 

 

We have moved this topic here.

We think it sensible to consult with non-treating experts to evaluate all of your options (standard and investigational) and to make sure that you do not miss opportunities or unnecessarily burn treatment bridges. 

Proposals to overcome obstacles to clinical trial enrollment
We have moved this topic here.

Patients Against Lymphoma Presentation
Cancer Vaccine Conference in Boston - April 2003

Harmonizing Research and Treatment Goals

Color PDF or B&W PDF version

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Ethics & Issues
  • Access to Emerging Treatments for patients with incurable cancers  Patient perspectives
  • Concerns about randomized vaccine trials  Patient perspectives
  • UNDERSTANDING CANCER PATIENTS' NEEDS, CONCERNS IS KEY TO IMPROVING CLINICAL TRIAL PARTICIPATION - UC Davis CC


Some Terminology on Clinical Trials 

Phase I trials - designed primarily to evaluate drug safety and evaluate dosing regimens. Represents the first use of a new drug in humans. In phase I studies you will find the newest drug candidates. Since there is less experience with phase I drugs, there is more inherent risk. However, phase I studies typically monitor patients closely and slowly increase the dose to reduce the risks. Phase I studies may be most appropriate for patients with disease that is refractory (resistant) to standard treatments. Generally, phase I trials are for patients who have exhausted options for curative therapies. But increasingly new drug candidates are more specific to a defect in the cancer cell, and therefore potentially less toxic.

Related research item: 
Less risks for patients participating in early phase cancer drug trials
- news-medical.net 
Lay comment: This item suggests that targeted therapies tend to be safer but less efficacious as single agents.  Note these trends are not blood-cancer specific.  Blood cancers being more sensitive to treatments than "solid" cancers,  including biologic and immune therapies.

Phase II trials - designed to assess a drug's efficacy, risks, side effects, and optimal dose in the target patient group. Based on the data from phase II studies, the drug sponsor will decide if phase III studies are indicated, and what the design of the phase III study should be in order to definitely demonstrate that the drug has clinical benefit. 

Phase III trials -designed to definitely establish if the new drug has clinical benefit by comparing it to a standard treatment (the control). Phase III studies typically includes a large number of patients randomly assigned to one of two treatment arms - the control or the investigational agent - in order to evaluate the new agent without bias. The data from these studies provides additional information on safety and efficacy, which will be included in the product's labeling if the drug is approved for marketing.

Controlled study  - a clinical trial that compares the outcome of a group of randomly assigned patients who receive the experimental treatment to the outcome of a group of randomly assigned patients who receive a standard treatment or an inactive placebo dose.

Dose-finding study - a study which compares the action of varying amounts of the experimental treatment to determine the optimum dose.  


Resources & Links  

Basic Information 
on Clinical Trials
  • Clinical trials acronym List  FDA.gov
  • Clinical Trials: Questions to Ask Your Doctor  Time  
  • FDA acronym list fda.gov
  • Well-Informed Patients Consider Joining Clinical Trials 
    Physicians Should Seek to Explain Benefits Whenever Possible ACS  
    If more physicians worked to increase their patientsí awareness about the value of clinical trials, participation might increase and help advance treatments for cancer, according to new research on patient attitudes about such studies, published in the August Journal of Clinical Oncology (Vol. 19, No. 15: 3554-3561).
Expanded Access
Patient Rights
  • Principles and Practices for Patient Safety and Protection in Clinical Trials
    06/17/2002 - John Yee, M.D., M.P.H. (posted by Page)
  • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.  WEB
  • Protecting Human Research Subjects.  HHS Fact Sheets. June 6, 2000.  WEB
  • Protecting Human Study Subjects  U.S. Food and Drug Administration, Center for Drug Evaluation and Research. October 25, 1999  PDF | PDF-Help
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Disclaimer:  The information on Lymphomation.org is not intended to be a substitute for 
professional medical advice or to replace your relationship with a physician.
For all medical concerns,  you should always consult your doctor. 
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