The Official Patient's Sourcebook on Lupus (8 page)

repeated once every 5 weeks for three cycles. Group 2-Same as for Group

1, except fludarabine injections are given intravenously (through a vein)

for the second treatment cycle. Patients in this group have frequent blood

sampling during the first and second treatment cycles to monitor blood

levels of the drug. Samples are collected before the first injection is given

and at 0.5, 1, 1.5, 2, 4, 8, 24 and 48 hours after the third injection. A total 12 tablespoons of blood is drawn over a 2-month period. All patients will

have blood drawn once or twice a week during the first two cycles and

then less frequently to monitor blood counts. Some patients will have the

following additional procedures to test the effects of treatment on

lymphocytes: 1. Blood sample collection 2. Bone marrow aspiration-The

skin over the hip bone is cleaned and a local anesthetic is injected into the

outer covering of the bone. Bone marrow is suctioned through the needle

into an attached syringe. The procedure is done before treatment begins,

at the end of treatment, and 6 months after treatment. 3. Tonsillar biopsy-

The tonsils are numbed with a local anesthetic and 1 to 4 pieces of tissue

are removed using special forceps. The procedure is done before

treatment begins, at the end of treatment, and 6 months after treatment. 4.

Magnetic resonance imaging (MRI) of the abdomen-The patients lies on a

table in a narrow cylinder (the MRI scanner) containing a strong

magnetic field, which is used to create images of parts of the body in

small section views. Patients will be followed for at least 24 months to

monitor late side effects and the response to treatment.

Phase(s): Phase I

36 Lupus Nephritis

Study Type: Interventional

Contact(s): Maryland; National Institute of Arthritis and Musculoskeletal

and Skin Diseases (NIAMS), 9000 Rockville Pike Bethesda, Maryland,

20892, United States; Patient Recruitment and Public Liaison Office 1-800-

411-1222 [email protected]; TTY 1-866-411-1010

Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001676

Benefits a
nd Risks19

What Are the Benefits of Participating in a Clinical Trial?

If you are interested in a clinical trial, it is important to realize that your participation can bring many benefits to you and society at large:

· A new treatment could be more effective than the current treatment for

lupus nephritis. Although only half of the participants in a clinical trial

receive the experimental treatment, if the new treatment is proved to be

more effective and safer than the current treatment, then those patients

who did not receive the new treatment during the clinical trial may be

among the first to benefit from it when the study is over.

· If the treatment is effective, then it may improve health or prevent

diseases or disorders.

· Clinical trial patients receive the highest quality of medical care. Experts watch them closely during the study and may continue to follow them

after the study is over.

· People who take part in trials contribute to scientific discoveries that may help other people with lupus nephritis. In cases where certain diseases or

disorders run in families, your participation may lead to better care or

prevention for your family members.

The Informed Consent

Once you agree to take part in a clinical trial, you will be asked to sign an

“informed consent.” This document explains a clinical trial’s risks and

benefits, the researcher’s expectations of you, and your rights as a patient.

19 This section has been adapted from ClinicalTrials.gov, a service of the National Institutes of Health:
http://www.clinicaltrials.gov/ct/gui/c/a1r/info/whatis?JServSessionIdzone_ct=9jmun6f291
.

Trials 37

What Are the Risks?

Clinical trials may involve risks as well as benefits. Whether or not a new

treatment will work cannot be known ahead of time. There is always a

chance that a new treatment may not work better than a standard treatment.

There is also the possibility that it may be harmful. The treatment you

receive may cause side effects that are serious enough to require medical

attention.

How Is Patient Safety Protected?

Clinical trials can raise fears of the unknown. Understanding the safeguards

that protect patients can ease some of these fears. Before a clinical trial

begins, researchers must get approval from their hospital’s Institutional

Review Board (IRB), an advisory group that makes sure a clinical trial is

designed to protect patient safety. During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are experiencing any

side effects. All the results are carefully recorded and reviewed. In many

cases, experts from the Data and Safety Monitoring Committee carefully

monitor each clinical trial and can recommend that a study be stopped at any

time. You will only be asked to take part in a clinical trial as a volunteer

giving informed consent.

What Are a Patient’s Rights in a Clinical Trial?

If you are eligible for a clinical trial, you will be given information to help you decide whether or not you want to participate. As a patient, you have

the right to:

· Information on all known risks and benefits of the treatments in the

study.

· Know how the researchers plan to carry out the study, for how long, and

where.

· Know what is expected of you.

· Know any costs involved for you or your insurance provider.

· Know before any of your medical or personal information is shared with

other researchers involved in the clinical trial.

· Talk openly with doctors and ask any questions.

38 Lupus Nephritis

After you join a clinical trial, you have the right to:

· Leave the study at any time. Participation is strictly voluntary. However,

you should not enroll if you do not plan to complete the study.

· Receive any new information about the new treatment.

· Continue to ask questions and get answers.

· Maintain your privacy. Your name will not appear in any reports based

on the study.

· Know whether you participated in the treatment group or the control

group (once the study has been completed).

What about Costs?

In some clinical trials, the research facility pays for treatment costs and other associated expenses. You or your insurance provider may have to pay for

costs that are considered standard care. These things may include inpatient

hospital care, laboratory and other tests, and medical procedures. You also

may need to pay for travel between your home and the clinic. You should

find out about costs before committing to participation in the trial. If you

have health insurance, find out exactly what it will cover. If you don’t have

health insurance, or if your insurance company will not cover your costs,

talk to the clinic staff about other options for covering the cost of your care.

What Should You Ask before Deciding to Join a Clinical Trial?

Questions you should ask when thinking about joining a clinical trial include

the following:

· What is the purpose of the clinical trial?

· What are the standard treatments for lupus nephritis? Why do

researchers think the new treatment may be better? What is likely to

happen to me with or without the new treatment?

· What tests and treatments will I need? Will I need surgery? Medication?

Hospitalization?

· How long will the treatment last? How often will I have to come back for

follow-up exams?

· What are the treatment’s possible benefits to my condition? What are the

short- and long-term risks? What are the possible side effects?

Trials 39

· Will the treatment be uncomfortable? Will it make me feel sick? If so, for

how long?

· How will my health be monitored?

· Where will I need to go for the clinical trial? How will I get there?

· How much will it cost to be in the study? What costs are covered by the

study? How much will my health insurance cover?

· Will I be able to see my own doctor? Who will be in charge of my care?

· Will taking part in the study affect my daily life? Do I have time to

participate?

· How do I feel about taking part in a clinical trial? Are there family

members or friends who may benefit from my contributions to new

medical knowledge?

Keeping Current on Clinical Trials

Various government agencies maintain databases on trials. The U.S. National

Institutes of Health, through the National Library of Medicine, has

developed ClinicalTrials.gov to provide patients, family members, and

physicians with current information about clinical research across the

broadest number of diseases and conditions.

The site was launched in February 2000 and currently contains

approximately 5,700 clinical studies in over 59,000 locations worldwide, with

most studies being conducted in the United States. ClinicalTrials.gov

receives about 2 million hits per month and hosts approximately 5,400

visitors daily. To access this database, simply go to their Web site

(
www.clinicaltrials.gov
) and search by “lupus nephritis” (or synonyms).

While ClinicalTrials.gov is the most comprehensive listing of NIH-supported

clinical trials available, not all trials are in the database. The database is updated regularly, so clinical trials are continually being added. The

following is a list of specialty databases affiliated with the National Institutes of Health that offer additional information on trials:

· For clinical studies at the Warren Grant Magnuson Clinical Center

located in Bethesda, Maryland, visit their Web site:

http://clinicalstudies.info.nih.gov/

40 Lupus Nephritis

· For clinical studies conducted at the Bayview Campus in Baltimore,

Maryland, visit their Web site:

http://www.jhbmc.jhu.edu/studies/index.html

· For trials on diseases of the digestive system and kidneys, and diabetes,

visit the National Institute of Diabetes and Digestive and Kidney

Diseases:
http://www.niddk.nih.gov/patient/patient.htm

General References

The following references describe clinical trials and experimental medical

research. They have been selected to ensure that they are likely to be

available from your local or online bookseller or university medical library.

These references are usually written for healthcare professionals, so you may

consider consulting with a librarian or bookseller who might recommend a

particular reference. The following includes some of the most readily

available references (sorted alphabetically by title; hyperlinks provide

rankings, information and reviews at Amazon.com):

·
A Guide to Patient Recruitment : Today’s Best Practices & Proven

Strategies
by Diana L. Anderson; Paperback - 350 pages (2001), CenterWatch, Inc.; ISBN: 1930624115;

http://www.amazon.com/exec/obidos/ASIN/1930624115/icongroupinterna

·
A Step-By-Step Guide to Clinical Trials
by Marilyn Mulay, R.N., M.S., OCN; Spiral-bound - 143 pages Spiral edition (2001), Jones & Bartlett Pub; ISBN: 0763715697;

http://www.amazon.com/exec/obidos/ASIN/0763715697/icongroupinterna

·
The CenterWatch Directory of Drugs in Clinical Trials
by CenterWatch; Paperback - 656 pages (2000), CenterWatch, Inc.; ISBN: 0967302935;

http://www.amazon.com/exec/obidos/ASIN/0967302935/icongroupinterna

·
The Complete Guide to Informed Consent in Clinical Trials
by Terry

Hartnett (Editor); Paperback - 164 pages (2000), PharmSource Information

Services, Inc.; ISBN: 0970153309;

http://www.amazon.com/exec/obidos/ASIN/0970153309/icongroupinterna

·
Dictionary for Clinical Trials
by Simon Day; Paperback - 228 pages (1999), John Wiley & Sons; ISBN: 0471985961;

http://www.amazon.com/exec/obidos/ASIN/0471985961/icongroupinterna

·
Extending Medicare Reimbursement in Clinical Trials
by Institute of

Medicine Staff (Editor), et al; Paperback 1st edition (2000), National

Academy Press; ISBN: 0309068886;

http://www.amazon.com/exec/obidos/ASIN/0309068886/icongroupinterna

Trials 41

·
Handbook of Clinical Trials
by Marcus Flather (Editor); Paperback (2001), Remedica Pub Ltd; ISBN: 1901346293;

http://www.amazon.com/exec/obidos/ASIN/1901346293/icongroupinterna

Vocabulary Builder

The following vocabulary builder gives definitions of words used in this

chapter that have not been defined in previous chapters:

Abdomen:
That portion of the body that lies between the thorax and the pelvis. [NIH]

Antibody:
An immunoglobulin molecule that has a specific amino acid

sequence by virtue of which it interacts only with the antigen that induced

its synthesis in cells of the lymphoid series (especially plasma cells), or with antigen closely related to it. Antibodies are classified according to their ode of action as agglutinins, bacteriolysins, haemolysins, opsonins, precipitins,

etc. [EU]

Aspiration:
The act of inhaling. [EU]