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The following pages answer some frequently asked questions about the numbers of cancer trials in progress in the United States and the participants in these trials.
NCI Trials
Patients in NCI Trials
Physicians in NCI Trials
Funding and Costs
Other Sponsors of Cancer Trials
Cancer Drugs in Trials
How many National Cancer Institute trials are now in progress?
Because NCI supports clinical trials through a variety of funding programs (grants, contracts, cooperative agreements, etc.), there is no single listing or database of all NCI trials and therefore no simple answer to this question. One of the most comprehensive databases of cancer clinical trials is the National Cancer Institute's
PDQ® database, accessible through the NCI Web site. PDQ includes most trials sponsored or conducted by NCI. It also includes many cancer trials sponsored by pharmaceutical companies, medical centers, and other groups. It lists both active studies (currently enrolling patients) and those closed to enrollment.
In July 2002, PDQ contains about 1,700 active trials, of which approximately 1,200 are sponsored or conducted by NCI.
Which NCI trials does PDQ include?
PDQ includes most intramural trials -- those being conducted by NCI researchers at the National Institutes of Health in Bethesda, Md. It also contains many extramural trials -- those sponsored by NCI and taking place at cancer centers, hospitals, and community practices around the country.
Of NCI's extramural trials, PDQ includes all that are conducted through the Clinical Trials Cooperative Groups (networks of researchers and institutions with funding from NCI). It also includes some of the trials funded through other kinds of funding mechanisms, such as grants and contracts, and trials taking place at NCI-designated cancer centers. (Investigators with grants and contracts funded by the NCI are encouraged to submit protocols to PDQ but it is not mandatory.)
July 2002 listings in PDQ include:
Intramural trials at the National Institutes of Health: 143 Extramural trials: 1,033 Cooperative Group trials: 400 NCI grant supported trials: 212 NCI-designated cancer center trials: 337 A variety of other funding mechanisms account for the remaining extramural trials.
In PDQ, how many NCI trials are there for the four major types of cancer?
For the four types of cancer with the highest number of new cases annually (incidence) and the highest mortality rates, the number of NCI trials listed in PDQ is, as of July 2002:
In PDQ, how many NCI treatment, prevention, and other kinds of trials are there?
As of July 2002 there were:
Can you search PDQ using criteria other than type of cancer and kind of clinical trial?
Yes. You can also search PDQ on the Internet by the phase of the trial, the type of treatment or intervention (e.g., chemotherapy, vaccine therapy), the drugs being tested, the location of the trial, and other criteria. See the
User's Guide for PDQ Clinical Trials Search for more information. You can also request a search of PDQ by calling NCI's Cancer Information Service at 1-800-4-CANCER. Health professionals can request a search by contacting the CancerNet Search Service at 1-800-345-3300.
What NCI trials does PDQ not include?
Some NCI-sponsored trials may not appear in PDQ because it is not mandatory for investigators to submit trials to the database. Trials missing from PDQ include some of the trials funded through NCI grants or contracts and some taking place at NCI-designated cancer centers.
Some NCI-designated cancer centers maintain lists of their own clinical trials on their Web sites.
Are there other databases that include NCI trials?
Yes. The National Institutes of Health (NIH), of which NCI is a part, maintains two databases or registries of clinical trials:
ClinicalTrials.gov contains approximately 7,000 clinical studies (not just cancer trials) sponsored by the National Institutes of Health, other federal agencies, and the pharmaceutical industry. It includes all cancer trials that are listed in the NCI registry of trials, PDQ.
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The CRISP database lists and describes biomedical research grants and contracts funded by the Department of Health and Human Services, NIH's parent agency. As of July 2002, it includes about 280 listings for current, investigator-initiated (R01) grants that involve cancer clinical trials and about four contracts for cancer trials. Some, but not all, of the trials in CRISP are listed in PDQ. (CRISP stands for Computer Retrieval of Information of Scientific Projects.)
There are also other Web sites, such as some of those maintained by professional and voluntary groups, that have lists of cancer clinical trials.
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How many patients take part in NCI treatment trials?
In recent years (from 1997-2001), more than 25,000 cancer patients enrolled annually in NCI treatment trials. This figure includes:
22,600 patients in extramural treatment trials carried out by NCI's Clinical Trials Cooperative Groups (networks of physicians and institutions that carry out trials jointly). This includes about 7,000 patients enrolled through the
Community Clinical Oncology Program, or CCOP, which is a network of 50 central offices in 30 states that provides the infrastructure to link community cancer specialists and primary care physicians with the Cooperative Groups. It also includes patients enrolled through minority-based CCOPs. 2,300 patients in intramural trials.
How does this break down by gender?
- On average, from 1997-2001 about 60 percent of the combined participants from NCI Cooperative Group trials and intramural treatment trials were women, and about 40 percent were men. During the same period, slightly more men than women were newly diagnosed with cancer.
- In an analysis of trial enrollment from April 1998-April 1999 , more women than men 30 years of age and older participated in Cooperative Group trials; however, more men than women were recruited for non-gender-specific cancer trials.
What percentages of adults and children with cancer enroll in NCI Cooperative Group trials?
An analysis of NCI Cooperative Group trial enrollment from 1998-1999 showed that about 2.5 percent of adult cancer patients participate. The percentages for children are much higher than those for adults. Percentages of cancer patients participating in Cooperative Group trials, by age:
| 0-14 years old |
50.0 % |
| 15-19 years old |
20.0 % |
| 20 and older |
2.5 % |
| 70 and older |
<1.0 % |
Why is the percentage for children so much higher than that for adults?
Experts suggest several reasons:
Childhood cancer is a rare disease and therefore is often treated in large, specialized or academic treatment centers, where many trials are in progress.
The physicians who care for children with cancer are familiar with clinical trials and frequently talk to patients and families about trials.
Most childhood cancers are leukemias and lymphomas, which have included many research opportunities in recent decades; that is, many new treatments have evolved in laboratories and so many clinical trials have been available.
What proportion of older cancer patients enroll in NCI cancer treatment trials?
The incidence of cancer increases with age. In an analysis of average annual cancer incidence rates from 1995-1999, the median age for the incidence of all cancers combined was 68 years. For the four most common cancers (breast, prostate, lung, and colorectal) the percentage of cancer patients aged 65 and older ranged from nearly 50 percent to more than 70 percent.
Yet older cancer patients tend not to enroll in cancer clinical trials:
- For intramural trials during 2001, about 14 percent of participants were over the age of 65. (Source: NCI's
Center for Cancer Research.)
Why are older people underrepresented in clinical trials?
Experts have suggested several possible explanations:
Research focuses on aggressive therapies, which may be thought unacceptably toxic to the elderly.
Older people more often have other health problems (co-morbidities) or have had an earlier cancer that bar them from trials.
Few trials are specifically designed for older patients.
Physicians, patients and family members may think that older patients are less likely to benefit from and less able to tolerate aggressive treatment.
Older patients are more likely to be diagnosed with advanced-stage disease, and more trials are designed for early-stage disease.
Older patients may be less aware of medical developments and less likely to seek out clinical trials.
There is a lack of financial, logistic and social support for participation of older patients in trials.
What proportion of participants in NCI treatment trials belong to minority groups?
A study of participants in NCI Cooperative Group trials from 1991-1994 found that participation of African Americans and Hispanics was roughly proportional to the incidence of cancer (number of new cases per year) among these groups.
More recent (1998-1999) data from other sources confirm this picture:
Minority Representation in NCI Cooperative Group Trials:
|
% of all participants*
|
% of new cancer cases/year**
|
| African American |
9 |
10 |
| Hispanic |
5 |
8 |
| Non-Hispanic white |
81 |
82 |
*Source: NCI's Cancer Therapy and Evaluation Program (CTEP)
**Source: NCI's Surveillance, Epidemiology, and End Results (SEER) Program
Minority Representation in NCI Intramural Trials:
|
% of all participants*
|
| African American |
10 |
| Hispanic |
4 |
| Asian |
2 |
| Non-Hispanic white |
83 |
*Source: NCI's Center for Cancer Research (CCR)
A study of participants in NCI Cooperative Group trials from 1998-1999, however, pointed out some differences across race and ethnic groups. Up to 29 years of age, participation in NCI Cooperative Group trials is comparable across race and ethnicities. But between ages 30 and 79, fewer African-American men and fewer Asian-American and Hispanic men and women participate in such trials, compared to whites in the same age range.
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How many physicians are involved in conducting NCI extramural trials?
About 7,925 physicians in the United States and Canada belong to NCI's Cooperative Groups. An additional 2,500 community cancer specialists and primary care physicians take part in NCI-sponsored trials through the Community Clinical Oncology Program. And about 250 physicians participate in minority-based CCOPs.
Where are these physicians located?
These physicians are located in institutions around the U.S. and Canada, including cancer centers, academic or teaching hospitals, and community hospitals.
Cooperative Group institutions: 1,700
CCOP community hospitals: 360 Minority-Based CCOP community hospitals: 40
NCI is engaged in a
major effort to increase the number of physicians taking part in trials.
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How much money does NCI spend on clinical trials and what does it cover?
In fiscal year 2001, NCI spent $649 million on clinical trials. These funds help pay for some of the costs associated with trials, such as developing concepts; preparing and reviewing protocols; monitoring for safety and accuracy; collecting and analyzing data; and preparing and shipping experimental drugs.
What costs are the responsibility of the patient's health plan?
In extramural trials, the patient's health plan (or the patient) pays for the patient care costs associated with the study. Patient care costs can include, for example, laboratory tests, office visits, and the administration of anti-cancer drugs. Health plans are also expected to cover drugs that are not experimental. These may include supportive medicines, such as anti-nausea drugs. The NCI provides experimental drugs.
Is it more expensive to participate in a trial than to receive standard treatment?
Recent studies have found that the costs of caring for patients enrolled in clinical trials are not substantially greater than the costs of standard care. Additional larger studies are in progress.
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What other federal government agencies sponsor cancer trials?
In addition to the National Cancer Institute, several other institutes at the National Institutes of Health (NIH) sponsor or conduct clinical research related to cancer. For example, the National Heart, Lung and Blood Institute has trials for blood-related cancers, such as leukemia, and the National Institute of Diabetes and Digestive and Kidney Diseases has clinical studies for patients with non-beta islet cell tumor, a type of pancreatic cancer, and for prostate cancer. The National Institute of Neurological Disorders and Stroke conducts trials for patients with brain tumors.
Outside NIH, the two major federal agencies carrying out cancer trials are:
Department of Defense (DoD): The DoD's Congressionally Directed Medical Research Program (CDMRP) sponsors research, including clinical trials in cancer. More information is available on the CDMRP Web site or from CDMRP's public affairs office, 301-619-7783. Department of Veteran's Affairs (VA): The VA conducts cancer trials at many of its medical centers around the country, funded through its own appropriations as well as through grants from the National Cancer Institute and pharmaceutical companies.
(U.S. veterans and Department of Defense TRICARE beneficiaries can participate in NCI-sponsored cancer clinical trials as part of their health benefits. For more information, see Digest Page: Veterans Affairs and Department of Defense Beneficiaries.)
What voluntary groups sponsor trials?
Many foundations and other voluntary groups provide funding for cancer research. Major sponsors include:
American Cancer Society (ACS): As of October 2002, the ACS supported 37 clinical research projects, including 17 phase III randomized trials. General information on ACS research is available from its Web site and by calling toll-free 1-800-ACS-2345.
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Susan G. Komen Foundation: The Komen Foundation sponsors a wide range of basic, clinical and translational research studies on breast cancer. In 2002, eight of these were clinical trials. More information on the foundation is available on its Web site or by calling 972-855-1600.
How many pharmaceutical companies are involved in cancer treatment trials?
As with government-sponsored trials, there is no single, all-inclusive database of trials sponsored by drug companies and therefore no simple, precise answer to this question. The most comprehensive listing of pharmaceutical and biotech company trials comes from an annual survey on new medicines in development for cancer, published by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA does not limit its survey to its own members, but aims to include all drugs in development at U.S. companies and the National Cancer Institute. Nearly 200 different companies appear in PhRMA's most recent survey (2001).
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How many anti-cancer drugs are in clinical trials?
Several hundred. In 2001, for example, there were 402 different drugs in cancer trials, according to a survey on new medicines in development for cancer, published by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA does not limit its survey to its own members, but aims to include all drugs in development at U.S. companies and NCI.
How many of these are being developed by or with support from the National Cancer Institute?
For about 100 of the drugs listed on the 2001 PhRMA survey of new medicines under development for cancer, NCI filed the Investigational New Drug (IND) application with the Food and Drug Administration and is now sponsoring or conducting the trials in conjunction with the companies. (An IND must be filed before a drug can be tested in humans.)
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