Organizations that Sponsor Clinical Trials
Finding Information on Cancer and Clinical Trials
Exercises

Overview

Cooperative groups, cancer centers, hospitals, and local physician offices conduct clinical trials. NCI, pharmaceutical companies, and other groups may fund them. They take place in diverse locations all over the country.

When locating clinical trials, it is important to remember that no single resource, including those from NCI, lists every cancer clinical trial.

Learning Objectives By reading this section and completing the exercises, you will be able to: Identify who sponsors cancer clinical trials Describe the role of NCI in how clinical trials are conducted at sites throughout the United States Describe the process by which people can be referred to clinical trials Explain ways to locate clinical trials

Organizations that Sponsor Clinical Trials

NCI, pharmaceutical companies, medical institutions, and other organizations sponsor clinical trials. NCI often partners with pharmaceutical companies to develop new agents.

Regardless of sponsor, clinical trials take place at universities, large medical centers, small hospitals, and doctors' offices. Individual physicians at cancer centers and other medical institutions can also sponsor clinical trials themselves. 

NCI-Sponsored Clinical Trials

NCI sponsors many clinical trials around the country that are conducted through four different programs:

1. Clinical Trials Cooperative Group Program

2. Community Clinical Oncology Program (CCOP) and the Minority-Based Community Clinical Oncology Program (MBCCOP)

3. Cancer Centers Program

4. Clinical Grants Program

All NCI-sponsored trials must meet all FDA and Office for Human Research Protections (OHRP) regulations for participant protection in clinical trials.

Clinical Trials Cooperative Group Program

Clinical trials are often conducted through NCI cooperative clinical trial groups, which are networks of institutions that jointly carry out large clinical trials following the same protocols. Members of these groups include:

• University hospitals

• Cancer centers

• Community physicians and community hospitals

Cooperative groups develop and conduct new clinical trials that follow national priorities for cancer research. They conduct phase 3 trials as well as phase 2 trials.

Some of the groups are categorized by type of cancer, others by type of treatment, and at least one by age of participants. Other groups are regional or focus on several cancer types.

There are 12 groups in the Clinical Trials Cooperative Group Program:

1. American College of Surgeons Oncology Group (ACOSOG)

2. Cancer and Acute Leukemia Group B (CALBG)

3. Children's Cancer Study Group (CCSG)

4. Eastern Cooperative Oncology Group (ECOG)

5. Gynecologic Oncology Group (GOG)

6. Intergroup Rhabdomyosarcoma Study Group (IRSG)

7. National Surgical Adjuvant Breast and Bowel Project (NSABP)

8. National Wilms Tumor Study Group (NWTSG)

9. North Central Cancer Treatment Group (NCCTG)

10. Pediatric Oncology Group (POG)

11. Radiation Therapy Oncology Group (RTOG)

12. Southwest Oncology Group (SWOG)

For more information about the Cooperative Group program, see http://ctep.info.nih.gov.

Community Clinical Oncology Programs (CCOPs) and Minority-Based CCOPs (MBCCOPs)

These programs allow community physicians to work with scientists conducting NCI-supported clinical trials. Participation in the CCOP benefits lay people and health professionals in the community as well as scientists in research centers.

The MBCCOP provides members of ethnic and racial minorities with access to state-of-the-art cancer treatment, prevention, and control technology.

Cancer Centers Program

NCI cancer centers conduct clinical trials under an NCI-approved protocol review and surveillance mechanism.

The Cancer Centers Program consists of more than 50 NCI-designated cancer centers involved in many different cancer research efforts. Cancer centers also participate in at least one cooperative group.

Clinical Grants Program

Many clinical trial protocols are carried out under the direct support of an NCI peer-reviewed grant.

Industry-Sponsored Trials

Pharmaceutical and biotech companies conduct their own trials, both locally and nationally. They may have as partners universities, hospitals, NCI, or local doctors. These trials are subject to the companies' own review panels and to an IRB, which may be local or national in scope.

Referrals to Clinical Trials

Once someone is diagnosed with cancer, the health care provider may suggest several possible treatment options, one of which may be a clinical trial. Similarly, health care providers may offer people at high risk for cancer several options for prevention, including a clinical trial. If a person finds that his or her physician does not participate in clinical trials, the person can request a referral to a physician who does.

Decisions concerning eligibility for clinical trials are often complicated, requiring very specific medical information about the person's condition and previous treatment. For that reason, it is always preferable to have a health care professional familiar with the person's case make the initial contact with the clinical trials team. People making calls directly may have insufficient medical information, which may make decisions about eligibility difficult and frustrating - for both the person making the call and for the researcher taking the call.

Once contact with a clinical trial team is made, the clinical trial staff assists potential participants and their health care providers with information about potential clinical trials at the institution. Depending on the institution, a referral coordinator, protocol assistant, or nurse may accept telephone, mail, and e-mail inquiries from physicians, potential participants, and others about a clinical trial. Preliminary eligibility can be evaluated by phone, and appointments with the clinical trial team can be scheduled.

Both patients and health care providers can find specific trials through PDQ, NCI's comprehensive cancer trial database. For more information on PDQ, see "Finding Information on Cancer and Clinical Trials."

Finding Information on Cancer and Clinical Trials

NCI Resources

NCI's Web site, www.cancer.gov, provides access to a wealth of information on clinical cancer care. The site contains information from PDQ, including the latest information about cancer treatment, screening, prevention, genetics, supportive care, and complementary and alternative medicine, as well as a registry of cancer clinical trials. Clinical oncology specialists review current literature from more than 70 medical journals, evaluate its relevance, and synthesize it into clear summaries, which are then reviewed monthly and updated as needed based on new information. Most cancer information summaries appear in two versions: 1) a technical version for the health professional, and 2) a nontechnical version for patients, their families, and the public. Many of the summaries are also available in Spanish.

The NCI Web site also includes approximately 100 fact sheets on various cancer-related topics, information on ordering NCI publications, and educational features and news summaries concerning the latest results from cancer clinical trials.

NCI's clinical trials registry (PDQ) contains more than 1,800 ongoing clinical trials, including information about studies around the world. All clinical trials undergo review prior to inclusion. Although no single resource lists every cancer clinical trial being conducted in the United States and abroad, PDQ is the most comprehensive cancer clinical trials registry; it contains information about trials sponsored by NCI, the pharmaceutical industry, and some international groups. Users can narrow their search by multiple parameters, such as stage of disease, phase of trial, treatment modality, and geographic location. PDQ also contains an archival file of more than 11,000 clinical trials that are no longer accepting patients, including contact information for the principal investigators of trials that may not yet be published in the biomedical literature.

Accessing NCI's Clinical Trials and Cancer Information by Phone

NCI's Cancer Information Service - NCI's Cancer Information Service is a national information and education network for patients, the public, and health professionals. From regional offices covering the entire United States, Puerto Rico, and the U.S. Virgin Islands, trained staff provide the latest cancer information through a toll-free telephone service. Staff can respond to calls in either English or Spanish. With regional offices throughout the United States, CIS staff members may work with organizations and professionals to plan, implement, and evaluate culturally appropriate clinical trials education programs using the Clinical Trials Education Series.

Access: The toll-free number is 1-800-4-CANCER (1-800-422-6237). For deaf and hard of hearing callers with TTY equipment, the number is 1-800-332-8615. Hours of operation are Monday through Friday, 9:00 a.m. to 4:30 p.m., local time. Callers also have the option of listening to recorded information about cancer 24 hours a day, 7 days a week.

NIH Web Site - It is important to note that there is no single resource that lists every cancer clinical trial being conducted in the United States and abroad. However, in 2000 the National Institutes of Health launched a new Web site, www.clinicaltrials.gov, that aims to be a complete listing of all U.S. Government- and industry-sponsored clinical trials, including cancer trials.

The site contains approximately 7,200 clinical trials, most of them Government-sponsored. However, additional trials from the pharmaceutical industry are being added.

Other Web Sites

The Internet includes a variety of clinical trial databases and matching services. The owners of these sites can be:

• Not-for-profit organizations, where the content providers may be volunteers and the site may be supported by an academic institution or foundation

• Companies that are heavily funded by investors who pharmaceutical companies pay every time a patient signs up for a clinical trial

• Something in between (e.g., a for-profit organization that gives some of its profits back to the cancer community)

Anyone interested in using any of these online services to find a clinical trial should ask a number of questions and evaluate the information before submitting personal information or calling an investigator from the service:

• Who owns/runs the site?

• Where does the financial backing come from?

• How does the service get paid? By matching people to trials? By clinical trial submission to the database? Other?

• Does anyone make money on this site? If so, then who?

• What is the source of clinical trial information?

• Does the site include all clinical trials? All Government-supported trials? All pharmaceutical trials?

Most people would like to have all of their treatment/prevention choices presented in an unbiased way before they make important health-related decisions. People may wish to look at the information from many of these sites and consider the source of the information before deciding what actions to take.

Guide To Finding Clinical Trial Resources
National Cancer Institute's PDQ	What is it?	How do I access it?	What will it provide?
	Database produced by NCI Registry of approximately 1,800 active cancer clinical trials	www.cancer.gov Go to the clinical trials area and follow the search directions OR Call 1-800-4-CANCER	Summaries about clinical trials conducted by NCI-sponsored researchers, the pharmaceutical industry, and some international groups
National Library of Medicine	Database produced by NIH Registry now lists 4,000 primarily NIH-supported clinical studies on many conditions, and more will be added All trials on PDQ are listed in this database	Go to www.clinicaltrials.gov Can browse by disease or sponsor or insert key words	Summaries about clinical trials for a wide range of conditions-   most of the trials listed are sponsored by NIH
Local Cancer Center Web Sites	Locally produced Web sites that include listings for trials sponsored by NCI and some pharmaceutical companies   Good supplementary resources for locating clinical trials; a cancer center may begin participating in an NCI-sponsored trial before the center's information is listed in PDQ	Different sites can be found through: cancer.gov Local institutions Call 1-800-4-CANCER for a center near you Information on trials taking place at NCI's Clinical Center in Bethesda, Maryland is available at http://ccr.nci.nih.gov then select "clinical trials" Some centers may also have telephone information centers	Information that varies from center to center
Example of Pharmaceutical Resources/Internet Clinical Trial Matching Sites	Pharmaceutical Research and Manufacturers of America (PhRMA) publishes a list of new cancer drugs in development   CenterWatch's Clinical Trials Listing Service and EmergingMed.com's clinical trials matching service lists many industry- and Government-sponsored trials	PhRMA Click on "New Medicines in Development" and search by disease. The drugs are listed by cancer type or call 202-835-3400. CenterWatch Click on "Trial Listings" and then "CenterWatch Trial Listings by Medical Areas" or call 617-856-5900 EmergingMed.com or call 877-601-8601	Descriptions, sites, telephone numbers, and investigator names by state

Exercise 5 Barriers to Participation

Exercise 5.1

Involvement in Clinical Trials

If a doctor seems too busy to refer a person to a clinical trial, can the person make the calls directly?

__________________________________________________________ __________________________________________________________ __________________________________________________________

Answers to Exercise 5.1

Exercise 5.2

Using PDQ to Locate Clinical Trials in Your Community

Choose two cancer diagnoses from the list below. Using www.cancer.gov, locate at least three clinical trials going on in your city or state.

When you have found at least three open trials, print out the patient versions and answer the question below. You can use NCI's PDQ or ask for printouts by calling 1-800-4-CANCER.

A. Someone diagnosed with stage II ovarian cancer who is looking for treatment options in your city and state

B. Someone diagnosed with stage IV colon cancer who needs options for supportive care

C. Someone diagnosed with stage III small cell lung cancer who needs options for treatment

D. Someone who is found to be at high risk for breast cancer who needs options for prevention

Question

What did you learn about clinical trials in your community or State?

__________________________________________________________ __________________________________________________________ __________________________________________________________

Back to Top

< Previous Section  |  Next Section >