Sponsorship
Making Referrals
Cancer Information and Clinical Trial Resources

Learning Objectives Describe the types of sponsorship of cancer clinical trials Define the role of the National Cancer Institute in conducting clinical trials throughout the United States Identify methods of referring patients to clinical trials Demonstrate ways of locating clinical trial resources

Sponsorship

In order to find a clinical trial, it is helpful to understand who sponsors trials. Clinical trials are sponsored by both Government and private organizations including the National Cancer Institute and pharmaceutical companies. Clinical trials take place all over the United States, in locations as diverse as a rural community clinic or a cancer center in a large urban area.

National Cancer Institute

NCI sponsors hundreds of clinical trials around the country through six major programs, which are discussed below.

Clinical Trials Cooperative Group Program

The Clinical Trials Cooperative Group Program supports a large network of organizations that continually generate and conduct new clinical trials consistent with national priorities in cancer treatment research. Member organizations carry out large, randomized phase 3 trials, as well as phase 2 trials.

Members conduct clinical trials in locations nationwide, while administration and data are handled at a central location. Members of the groups include:

• Academic institutions

• NCI-designated cancer centers

• Physicians in the Community Clinical Oncology Program and the Minority-Based Community Clinical Oncology Program (described below)

• Community physicians and community hospitals

Each year, the groups enroll some 20,000 new people in treatment trials, evaluate some 12,000 new participants in ancillary studies, and follow the progress of many times that many participants in ongoing trials. Thousands of individual investigators participate in these studies. The cooperative groups have been instrumental in developing both new standards of care for people with cancer and sophisticated clinical investigation techniques.

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 cooperative group information, see http://ctep.info.nih.gov. Select "Cooperative Group Program."

Cancer Trials Support Unit

NCI and the Clinical Trials Cooperative Group Program are collaborating in a pilot project - the Cancer Trials Support Unit (CTSU) - to reduce administrative burdens and recruit more physicians to become involved in clinical trials.

CTSU is designed to streamline and centralize many administrative, financial, and data collection tasks. CTSU will provide participating physicians with a single access point to NCI's entire phase 3 clinical trial system, facilitating access to protocols, training, and educational information. Highlights of the fully developed system will include:

• Cross-group registration enabling physicians to register people on adult cooperative group trials in leukemia, lung, genitourinary, colorectal, and breast cancers, even if they are not members of the group conducting the trial

• Online registration, eligibility assessment, and reporting of data that will use a common format and state-of-the-art data management systems

• A coordinated auditing system that will eliminate multiple quality assurance audits for research personnel participating in more than one cooperative group

• Centralization of administrative tasks, including credentialing and verification of IRB approval for all investigators participating in cooperative groups and CTSU

CTSU opened in July 2000 for cooperative group members. If the initial experience is successful, oncologists not affiliated with a group will be encouraged to participate as well.

For more information about CTSU, see www.ctsu.org.

Community Clinical Oncology Program

The Community Clinical Oncology Program (CCOP) enables community physicians to work with investigators conducting NCI-supported clinical trials. The program increases the number of participants and physicians who can take part in clinical trials operated simultaneously in major research centers and in the community. It benefits investigators by giving them an opportunity to conduct large-scale cancer prevention and control studies at the community level.

Facilities participating in the program must be affiliated with an NCI-supported clinical cooperative group or cancer center and use research protocols developed by these groups.

Minority-Based Community Clinical Oncology Program

The Minority-Based Community Clinical Oncology Program (MBCCOP) was initiated in 1990 to provide people with cancer who belong to minority groups access to state-of-the-art treatment, prevention, and control technology. The minority-based program was begun because 40 percent of the people with cancer referred to CCOP physicians each year are from a minority group. Each MBCCOP pledges to accrue more participants from minority groups than other CCOPs do.

Since funding began, participant enrollment in the minority-based program has grown to account for approximately 10 percent of all ethnic minorities enrolled in NCI-approved clinical trials.

Cancer Centers Program

The Cancer Centers Program consists of more than 50 NCI-supported research centers. Each cancer center also belongs to at least one cooperative group.

NCI supports three types of centers:

1. Comprehensive cancer centers, which conduct basic, clinical, and preventive research programs, as well as community outreach and education programs

2. Clinical cancer centers, which conduct primarily clinical research programs but may have programs in other research areas as well

3. Cancer centers (formerly called Basic Science Cancer Centers), which conduct basic or preventive research programs and do not have clinical programs

Please refer to http://cancercenters.cancer.gov/cancer_centers/index.html for a comprehensive list of cancer centers.

Clinical Grants Program

The Clinical Grants Program supports clinical researchers through various types of grants, all of which are peer reviewed.

Pharmaceutical and Biotech Companies

Pharmaceutical and biotech companies also conduct clinical trials, both locally and nationally. They may conduct these trials in collaboration with universities, hospitals, NCI, and local physicians. These trials are subject to the companies' own review panels and to an IRB, which may be local or national in scope.

Making Referrals

When a person is first diagnosed with cancer, his or her physician may suggest several possible options for treatment, possibly including a clinical trial. Likewise, a person at high risk of developing cancer may be offered prevention options that include a clinical trial.

Decisions concerning eligibility for cancer clinical trials are often complicated, requiring very specific information regarding a person's medical condition and prior treatment. For that reason, it is preferable to have a provider who is familiar with the person's case make the initial contact with clinical trial staff. A person who calls a researcher directly may have insufficient medical information, thereby making a decision about eligibility difficult and frustrating for both the potential participant and the researcher. Once contact is made, a referral coordinator may accept telephone, mail, or e-mail inquiries from physicians, potential participants, and others about the availability of clinical trials. Preliminary eligibility can be evaluated over the phone, and appointments with the clinical trial team can be scheduled if the person decides to proceed.

The informed consent process begins as soon as a potential participant begins to explore the trial with the clinical research team. The research team discusses the trial's purpose, procedures, risks, potential benefits, and participants' rights. After this dialogue, the person may wish to speak to his or her referring provider to review the information and help determine the best course.

If the person opts to enter the trial, the research team should send the referring provider relevant updates and followup information until the person returns to the provider's care.

Deciding to refer a person to a clinical trial is easier if the health care professional has adequate information regarding the trial's objectives and eligibility criteria. Before discussing a trial as an option, the professional should learn as much as possible about the trial.

Discussing Clinical Trials with Patients

Health care professionals may be able to assist potential trial participants in their decision by considering the following benefits and risks to clinical trial participation with their patients.

Possible Benefits of Clinical Trial Participation

• Participants will receive, at a minimum, the best standard treatment. This may be as good as, or better than, the new approach being tested.

• If a participant is taking the new treatment and it is shown to work, he or she may be among the first to benefit.

• By examining the benefits and drawbacks of clinical trials and other treatment choices, participants are taking an active role in a decision that affects their health care and life.

• Some participants feel good about helping advance medical knowledge that will improve cancer care and help others.

• Even when they don't lead to new therapies, clinical trials often answer important questions and help move research forward.

Possible Risks of Clinical Trial Participation

• New treatments are not always better than standard care.

• New treatments may have unexpected side effects that are worse than those of standard treatment.

• Although a new treatment is beneficial, it may not work for every participant. Even standard treatments do not help everyone.

• If a participant receives standard treatment instead of the new treatment being tested, it may not be as effective as the new approach.

• Participants may have additional patient care costs that are not covered by the study sponsor or by their health insurance or managed care plan.

• Participants may have to incur the costs of travel, childcare, lost work hours, hotels, and meals.

• Participation in a clinical trial may require increased patient responsibility, such as going to more appointments or self-monitoring for side effects.

Cancer Information and Clinical Trial Resources

NCI Resources

NCI's Web site, Cancer.gov, provides access to a wealth of information on clinical cancer care. The site contains information from PDQ® (Physician Data Query), 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 also has a Web-based continuing education tutorial on implementing clinical trials into your practice. This tutorial provides information for health care professionals interested in referring patients to trials, and more detailed information for health care professionals interested in actually implementing clincial trials into their practice. The series is available at cme.cancer.gov.

The clinical trials registry PDQ contains more than 1,800 ongoing clinical trials, with information about trials 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, and 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 participants, including contact information for principal investigators of trials that may not yet be published in the biomedical literature.

Accessing NCI's Clinical Trial and Cancer Information by Phone or Fax

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. The Cancer Information Service, with regional offices throughout the United States, 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

No single resource 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, that might:

  • Use volunteers to provide content

  • Be supported by an academic institution or foundation

• For-profit organizations, that might:

  • Receive a fee from pharmaceutical companies every time a person signs up for a trial

  • Give some of its profits back to the cancer community

Anyone interested in using online services to find a clinical trial should ask 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, who?

• What is the source of clinical trial information?

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

People may wish to look at information from many sites and consider the source of the information before making important health-related decisions.

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	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 list many industry- and Government-sponsored trials	PhRma.org Click on "New Medicines in Development" and search by disease. The drugs are listed by cancer type. Or call 202-835-3400. CenterWatch.com 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

Refer to the case study for a review and summary of content covered in this workbook.

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