Introduction How many NCI-supported trials are now in progress? Which NCI trials does PDQ include? How many NCI treatment, prevention, and other types of trials are listed in PDQ? How many NCI trials are listed for the four major types of cancer? What NCI trials does PDQ not include? Are there other databases that include NCI trials?

Patients Participating in NCI Treatment Trials

Background How many patients take part in NCI treatment trials? How many patients enroll in NCI intramural trials? How many patients enroll in NCI extramural trials? How does the patient population enrolled in NCI clinical trials break down according to gender? What percentages of adults and children with cancer enroll in NCI Cooperative Group trials? Why is the proportion of cancer patients participating in clinical trials higher for children than it is for adults? What proportion of older cancer patients enrolls in NCI cancer treatment trials? What proportions of participants in NCI treatment trials belong to racial or ethnic minority groups?

Physicians Participating in NCI-Supported Clinical Trials

Background How many physicians are involved in conducting NCI extramural trials? Where are these physicians located?

Costs Associated with NCI-Supported Clinical Trials

Background How much money does NCI spend on clinical trials and what do these funds pay for? What costs are the responsibility of the patient and his/her health plan? Is it more expensive to participate in a trial than to receive standard treatment?

Other Organizations Sponsoring Cancer Clinical Trials

Background What other federal agencies sponsor cancer trials? What nonprofit voluntary groups sponsor trials? How many pharmaceutical companies are involved in cancer treatment trials? How many anticancer drugs are being tested in clinical trials? How many of these drugs are being developed by or with support from NCI?

References

National Cancer Institute Clinical Trials: An Overview

Introduction

The National Cancer Institute (NCI) spent approximately 800 million dollars in fiscal year 2004 (the latest period for which actual expenditures are available) to fund a vast array of clinical trials designed to test new ways to treat, prevent, detect, or diagnose cancer as well as new methods to improve cancer patients' quality of life. NCI-supported clinical trials take place either intramurally at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, or extramurally at any of the hundreds of academic or private hospitals, cancer centers, or community-based medical practices located in the United States, Puerto Rico, Canada, and Europe that receive NCI funding.

The NCI clinical trials enterprise has grown incrementally over the past several decades. Today, the Institute funnels the majority of its funding dedicated to clinical trials to its extramural partners, which operate at the regional, state, and local levels in order to give the public the widest possible access to clinical studies. The major components of the Institute's extramural clinical research program include

• NCI-designated Cancer Centers and Comprehensive Cancer Centers, which are major academic and research institutions characterized by scientific excellence that sustain broad-based, interdisciplinary programs in cancer research;
• Specialized Programs of Research Excellence (SPOREs), which bring together basic scientists and clinical researchers to design and implement research programs that can improve cancer prevention, detection, diagnosis, and treatment of specific cancer types, including cancers of the breast, prostate, lung, gastrointestinal system, brain, and skin, as well as lymphoma, genitourinary cancer, head and neck cancer, and ovarian cancer;
• Clinical Trials Cooperative Groups, which are networks of research institutions organized according to region or medical specialty that collaborate to conduct large-scale, multisite clinical trials often involving thousands of patients; and
• Community Clinical Oncology Programs, which provide smaller-scale community-based medical facilities and individual physicians with opportunities to participate in clinical trials.

Each of these programs is discussed in greater detail below. Various offices throughout the Institute's major divisions provide administrative support for these programs, which are funded through a variety of mechanisms, including grants that support investigator-initiated basic, translational, or clinical research.

Because NCI's clinical research program is highly decentralized, it can be difficult to capture information that provides a comprehensive overview of the full spectrum of its activities. One of the best publicly accessible sources of up-to-date information about NCI-supported cancer clinical trials is the Physician Data Query (PDQ®) database. The first section of this report is largely based upon information drawn from PDQ and demonstrates how this resource may be used to answer specific questions about NCI-supported trials.

How many NCI-supported trials are now in progress?

There is no simple answer to this question. NCI supports clinical trials through a variety of funding programs, including grants, contracts, and cooperative agreements, and there is no single listing or database containing all NCI-sponsored trials.

One of the most comprehensive databases of cancer clinical trials is NCI's PDQ database, which is accessible through the NCI Web site, www.cancer.gov. PDQ includes most clinical trials sponsored by NCI. It also includes many cancer trials sponsored by pharmaceutical companies, medical centers, and other groups. PDQ lists both active clinical trials (those currently enrolling patients) and those closed to enrollment but still treating patients and/or collecting data. As of January 2006, PDQ contained approximately 2,932 active cancer clinical trials, of which 1,353 - almost half of the total - were sponsored by NCI.

Which NCI trials does PDQ include?

PDQ includes all intramural trials - those being conducted by NCI researchers at the NIH campus in Bethesda, Maryland. It also contains many extramural trials - those sponsored by NCI and taking place at cancer centers, hospitals, and community-based medical practices around the country and other parts of the world.

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). PDQ also includes many of the trials funded through other kinds of mechanisms, such as grants and contracts, and trials taking place at NCI-designated Cancer Centers. However, because registration of NCI-supported trials is not required, it is not possible to obtain a complete list of extramural trials through PDQ.

The January 2006 listings in PDQ included 183 active intramural clinical trials. A single figure for the sum total of active extramural trials taking place at any given time cannot be obtained from PDQ. Instead, the database lists categories of clinical trials that have been classified according to their specific scientific review process or funding mechanism(s). In January 2006, categories of extramural trials receiving NCI support included

• 415 Cooperative Group trials,
• 382 NCI-grant-supported trials,
• 29 Specialized Programs of Research Excellence (SPORE) trials, and
• 633 trials initiated by NCI-designated Cancer Centers.

Some clinical trials are funded through more than one administrative mechanism and are therefore included under more than one of the categories listed above. As a result, the sum total of the numbers above for intramural and extramural trials (1,642) exceeds the total number of NCI-sponsored clinical trials in the answer to question 1 (1,353).

How many NCI treatment, prevention, and other kinds of trials are listed in PDQ?

As of January 2006, there were

• 1,160 treatment trials,
• 55 prevention trials,
• 58 diagnostic trials,
• 17 screening trials,
• 20 genetics trials, and
• 116 supportive-care trials.

Some clinical trials can be classified as more than one type. For example, a screening trial might also be classified as a genetics trial if it is evaluating a screening method in patients who are genetically predisposed toward developing a particular type of cancer. As a result, the sum total of the numbers above (1,426) exceeds the total number of NCI-sponsored trials in PDQ (1,353) because some trials may be classified as more than one type.

How many NCI trials are listed in PDQ for the four major types of cancer?

As of January 2006, PDQ listed the following numbers of active NCI-sponsored clinical trials for the four types of cancer with the highest numbers of new cases (incidence) and deaths (mortality) annually:

• 133 for lung cancer (including 95 for non-small cell lung cancer, 33 for small cell lung cancer, and 3 for pulmonary carcinoid tumors),
• 192 for breast cancer (including 152 for female breast cancer and 40 for male breast cancer),
• 90 for prostate cancer, and
• 57 for colon cancer.

Which criteria can be used to search PDQ?

PDQ can be searched on the Internet using either the Basic Search Form or the Advanced Search Form.

The Basic Search Form allows people to search for trials using the criteria of cancer type or stage as well as the trial location (ZIP code proximity or NIH campus, Bethesda, Maryland). (See Help Using the Basic Clinical Trial Search Form for more information.)

With the Advanced Search Form, in addition to cancer type and trial location, people can search on the basis of the phase of the trial (phase I, II, III, or IV), the type of treatment or intervention (for example, chemotherapy or vaccine therapy), the drugs being tested, the sponsoring institution, and other criteria. (See Help Using the Advanced Clinical Trial Search Form.)

People may also request a customized search of PDQ from NCI's Cancer Information Service by calling 1-800-4-CANCER.

Which NCI trials does PDQ not include?

Some NCI-sponsored trials may not appear in PDQ because it is not mandatory for investigators to submit their trials to the database. Trials missing from PDQ include some funded through NCI grants or contracts and some taking place at NCI-designated Cancer Centers.

Are there other databases that include NCI trials?

Yes. The NIH, of which NCI is a part, maintains both a registry and a database that include clinical trials:

• ClinicalTrials.gov includes all cancer trials listed in PDQ. As of January 2006, the database contained more than 11,450 actively recruiting clinical trials for all disease types - including more than 4,400 for cancer and other neoplasms - sponsored by the NIH, other federal agencies, and the pharmaceutical industry.
• The CRISP (Computer Retrieval of Information on Scientific Projects) database lists and describes biomedical research grants and contracts funded by the Department of Health and Human Services, NIH's parent agency. At the end of 2004, this database included about 275 listings for current investigator-initiated (R01) grants for research projects involving the conduct of at least 1 cancer clinical trial.* At that time, CRISP also contained information describing contracts active during the period from 2001 through 2004. These contracts were designed either to support large-scale, multiyear prevention or screening trials or to provide centralized services, such as investigational drug production, for NCI clinical trials. Some, but not all, of the clinical trials in CRISP are also listed in PDQ.

_{*Note: Many of the clinical trials contained in CRISP are not yet active and, therefore, not yet listed in PDQ.}

There are other Web sites that make lists of cancer clinical trials available to the public, including some sites maintained by professional or voluntary groups. Some NCI-designated Cancer Centers maintain lists of their own clinical trials on their Web sites.

Most large cancer clinical trial databases, whether private or publicly accessible, derive information from PDQ.

Back to Top Patients Participating in NCI Treatment Trials

Background

The significance and value of a clinical trial depend upon many factors, including the characteristics of the patients participating in the study. Depending on the purpose of the clinical trial, researchers enroll people who are alike in certain ways - for example, age, gender, and general health status. These characteristics are referred to as the trial's eligibility criteria, and they help to ensure that the results of the trial will be due to what is under study - for example, the drug being tested - and not to other factors.

Yet within the limits defined by the eligibility criteria, researchers also attempt to include as many types of people as possible in a trial so that the results will be as broadly applicable as possible. The more diverse the trial's population, the more useful the results could be to the general population. This is particularly true for relatively large phase III trials. Results of phase III trials should be as generally applicable as possible in order to benefit the maximum number of people.

How many patients take part in NCI treatment trials?

From 2001 through 2003, an average of about 33,600 individuals enrolled in NCI treatment trials each year (internal data, unpublished). This figure includes patients who joined intramural clinical studies carried out at the NIH Clinical Center, located on the Bethesda campus, and patients who participated in extramural trials taking place at sites throughout the United States and in other parts of the world.

How many patients enroll in NCI intramural trials?

From January 2001 through December 2002, enrollment in NCI intramural clinical trials averaged almost 2,950 patients each year (internal data, unpublished).

Intramural clinical trials are planned, designed, and conducted by investigators in the NCI's Center for Cancer Research, the larger of NCI's two intramural research divisions. Most intramural trials are relatively small phase I or phase II studies. Individuals participating in intramural clinical studies travel to the NIH campus from locations throughout the United States and around the world.

How many patients enroll in NCI extramural trials?

From January 2001 through December 2003, NCI programs supporting extramural clinical trials at the international, national, regional, and community levels enrolled about 30,660 patients annually (internal data, unpublished).

NCI's extramural clinical trial research enterprise includes the following components:

• The Cancer Therapy Evaluation Program (CTEP)
  Part of NCI's Division of Cancer Treatment and Diagnosis, CTEP oversees all aspects of extramural clinical trials, including prioritization of clinical research initiatives, allocation of funds and other resources, clinical trial design, patient protections, and enforcement of standards governing data collection, monitoring, and reporting. One of CTEP's primary responsibilities involves promoting collaborations among basic scientists, academic researchers, practicing oncologists, and cancer experts both inside and outside the NIH.
• The Clinical Trials Cooperative Groups
  The Cooperative Groups make up the largest collaborative clinical research network administered by CTEP. From 2001 through 2003, they enrolled, on average, more than 26,600 patients in extramural clinical trials each year (internal data, unpublished). This figure represents about 86 percent of NCI's total annual patient accrual.*
• The Community Clinical Oncology Program (CCOP)
  The CCOP supports extramural trials through a network of community-based hospitals and medical practices that are affiliated with the Cooperative Groups. This program, administered by NCI's Division of Cancer Prevention (DCP), is responsible for approximately 30 percent of the accrual into extramural cancer treatment trials each year.^*
  
  NCI currently provides grants to 50 CCOP affiliates located in 30 states. Each affiliate is required to recruit at least 50 patients each year into treatment trials and another 50 individuals into control and prevention trials. To increase the participation of members of minority groups in clinical trials, DCP also provides grants to 13 minority-based CCOP affiliates. In addition, DCP provides grants to Cooperative Groups and NCI-designated Cancer Centers, which function as CCOP research bases, to design and conduct cancer prevention and control clinical trials through the CCOP networks. In 2004, CCOP affiliates collectively enrolled 6,000 patients into cancer treatment trials, and more than 7,900 participants into clinical studies involving cancer prevention and control (internal data, unpublished).

_{*Overlaps exist between the figures given for CCOP and those for Cooperative Group enrollment totals because these programs are interrelated.}

How does the patient population enrolled in NCI clinical trials break down according to gender?

From 2001 through 2003, approximately 63 percent of the participants in treatment trials overseen by CTEP were women and approximately 37 percent were men (internal data, unpublished).

What percentages of adults and children with cancer enroll in NCI Cooperative Group trials?

Less than 2 percent of the adults diagnosed with cancer in the United States each year receive treatment through enrollment in an NCI Cooperative Group clinical trial.^{1, 2} This low rate of clinical trial participation lengthens the time required to meet patient accrual targets for trials and, therefore, lengthens the time required to complete clinical trials, slowing the pace of progress in improving cancer treatments.

In contrast to the low level of adult enrollment, 55 to 65 percent of children in the United States who are diagnosed with cancer by or before the age of 14 years enter an NCI-sponsored clinical trial. This percentage drops to about 10 percent for children diagnosed between the ages of 15 and 19 years.³

The following table* shows the percentages by age of all cancer patients who participated in CTEP-supported treatment trials from 2001 through 2003:

_{*Source: internal data, unpublished.}

Why is the proportion of cancer patients participating in clinical trials higher for children than it is for adults?

Experts suggest several reasons.

• Childhood cancers are rare diseases and, therefore, are 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 been the focus of intense research during recent decades, making an unusually large number of clinical trials available to patients.

What proportion of older cancer patients enrolls in NCI cancer treatment trials?

An analysis of NCI Cooperative Group trial enrollment from 2001 through 2003 showed that 29 percent of trial participants were 65 years of age or older (internal data, unpublished). A similar analysis of NCI intramural clinical trials from 2001 through 2002 demonstrated that approximately 21 percent of the total number of participating patients belonged to this age group (internal data, unpublished).

Experts have suggested several possible explanations for the under-representation of older patients in cancer treatment trials.

• Trials often have strict age requirements that prevent elderly patients from enrolling.⁴
• Older people often have other health problems (co-morbidities) or a history of earlier cancer that limits their ability to participate in trials.^4-6
• Elderly patients may be taking drugs that increase the risk of dangerous drug-drug interactions with the medications being studied in a trial.^{4, 6}
• Older patients may be less aware of medical developments that reduce the toxicity of cancer treatments and are, therefore, less likely to seek out clinical trials.⁴
• Physicians, patients, and family members may think that older patients are less likely to benefit from and less able to tolerate aggressive treatment.
• Finally, there may be a lack of financial, logistic, and social support for participation of older patients in trials.^4-6

What proportions of participants in NCI treatment trials belong to racial or ethnic minority groups?

A study of participants in NCI Cooperative Group trials between 1991 and 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.⁷ Published data for the period ending in 2002 and unpublished data for the period from 2002 through 2003 from CTEP, which is summarized below, confirm this picture.

Ethnic Representation in CTEP Treatment Trials

_{*Source: internal data, unpublished.}

Racial Representation in CTEP Treatment Trials

_{*Source: internal data, not published.}

In recent years, the number of minority patients enrolled in cancer clinical trials has remained relatively stable, but the overall number of patients admitted to trials has increased, therefore decreasing the minority percentage.²

Back to Top Physicians Participating in NCI-Supported Clinical Trials

Background

Most cancer patients who elect to participate in clinical trials of new cancer treatments do so as a result of referrals by their physicians and/or because of information describing specific clinical research studies that their physicians confirm to be accurate. Most Americans regard their physicians as the single most reliable source for medical information available. Physicians act as a central conduit for patients electing to participate in clinical research and are, therefore, critically important to the Institute's clinical trials program and patient recruitment efforts.⁸

How many physicians are involved in conducting NCI extramural trials?

In 2004, more than 14,119 extramural investigators were registered to participate in Cooperative Group clinical trials (internal data, unpublished). Currently, 3,200 community cancer specialists and primary-care physicians take part in NCI-sponsored trials through CCOP, and an additional 500 participate in minority-based CCOP research centers (internal data, unpublished).

Where are these physicians located?

These physicians are located at cancer centers, academic or teaching hospitals, community hospitals, and other institutions throughout the U.S. and Canada, including

• 1,718 at Cooperative Group institutions,
• 380 at CCOP community hospitals, and
• 49 at minority-based CCOP community hospitals.*

_{*Source: internal data, unpublished.}

NCI is currently engaged in a major effort to increase the number of physicians taking part in clinical trials. One recently launched initiative is called the Clinical Trials Support Unit Independent Clinical Research Site (CICRS) program. CICRS (pronounced "scissors") provides fully credentialed individual physicians who specialize in oncology or hematology and who have the resources and staff needed to carry out rigorous clinical studies with the opportunity to enroll their patients in a wide range of phase III NCI Cooperative Group clinical trials. Participating physicians are not required to satisfy a minimum annual patient enrollment quota.

Back to Top Costs Associated with NCI-Supported Clinical Trials

Background

NCI's investment in cancer clinical trials is an investment in the future, one that promises not only to benefit individuals with cancer but also the society at large by reducing the financial burden exacted by the disease. Studies have demonstrated that the financial costs incurred by individuals who have chosen to participate in clinical trials have proved an impediment to some people who might otherwise have elected to enroll; in particular, older patients. Recognizing the value of the benefits that accrue to individuals and society as a result of robust clinical trial participation, the federal government and many states have enacted measures mandating insurance coverage for clinical trial participants.

How much money does NCI spend on clinical trials and what do these funds pay for?

In fiscal year 2004, the NCI spent approximately 800 million dollars on clinical trials.⁹ NCI funding helps pay for some of the costs associated with clinical trials, including:

• developing research concepts,
• preparing and reviewing trial protocols,
• monitoring patient safety,
• collecting and analyzing data,
• ensuring data accuracy, and
• manufacturing and distributing experimental drugs.

What costs are the responsibility of the patient or his/her health plan?

For participants in NCI-supported extramural trials, the Institute provides experimental drugs at no cost. Routine patient care costs associated with participation in an extramural trial, however, are paid for either by the patient or by his or her health plan. Patient care costs can include, for example, laboratory tests, office visits, and the administration of standard cancer-related drugs. Health plans are expected to cover drugs that are not experimental. These may include supportive medicines, such as antinausea drugs.

In 2000, Congress mandated a change in Medicare policy to require the coverage of routine patient care costs for clinical trial participants; evidence indicates that this change may have led to increased clinical trial participation by older patients who have Medicare coverage combined with supplemental private insurance coverage.¹⁰ For more information on reimbursement for medical costs associated with clinical trials, see Medicare Coverage of Clinical Trials and Private Insurers' Coverage of Clinical Trials.

Some states have passed legislation or instituted special agreements that require health plans to pay the cost of routine medical care that patients incur while participating in certain clinical trials. For more information on the specific provisions passed by individual states, see States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

There is no charge for medical care received at the NIH Clinical Center in Bethesda, Maryland, for patients participating in intramural trials. Patients are responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a study, the NCI will pay for the transportation costs for all study-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem for food and lodging expenses if they are being treated as outpatients.

Pediatric patients and family members can stay at the Children's Inn, which is located on the NIH campus close to the Clinical Center, at no charge, provided eligibility criteria are met. Family members and other loved ones of adult patients enrolled in clinical trials taking place at the NIH Clinical Center are also eligible to stay at the Edmond J. Safra Family Lodge at no charge. The Family Lodge, also located on the NIH campus, opened in May 2005; a complete list of its amenities and eligibility criteria is available on its Web site.

Is it more expensive to participate in a trial than to receive standard treatment?

Several studies have found that the costs of caring for patients enrolled in clinical trials are not substantially greater than the costs of standard care.^11-14 Additional larger studies exploring this issue are in progress.

Back to Top Other Organizations Sponsoring Cancer Clinical Trials

Background

Although the NCI represents the largest single organization supporting an extensive program of clinical trials testing new interventions designed to detect, diagnose, prevent, or treat cancer, many other public and private organizations in the United States and the rest of the world are also pursuing vigorous programs of clinical cancer research. In the United States itself, NCI partners or otherwise interacts with a large number of other federal agencies, private companies, and nonprofit organizations, including advocacy and voluntary groups, that are involved in supporting or conducting cancer clinical trials. These alliances accelerate the pace of scientific and medical progress.

What other federal government agencies sponsor cancer trials?

In addition to NCI, several other NIH institutes or centers sponsor clinical research studies related to cancer. For example

• The National Heart, Lung and Blood Institute is sponsoring trials for blood-related cancers, such as leukemia.
• The National Institute of Child Health and Development is sponsoring trials for patients with adrenal gland or pituitary gland tumors.
• The National Institute of Neurological Disorders and Stroke is sponsoring trials for patients with brain tumors.
• The National Institute of Nursing Research is sponsoring trials related to supportive care and the quality of life of cancer patients.
• The National Center for Complementary and Alternative Medicine is sponsoring trials related to the treatment, supportive care, and quality of life of patients with cancer.
• The National Human Genome Research Institute is sponsoring trials related to the genetic basis of various cancers.

Other NIH Institutes that have sponsored clinical trials for cancer include the National Institute of Allergy and Infectious Diseases (AIDS-related cancers), the National Eye Institute (ocular melanoma), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (skin cancers), and the National Institute of Diabetes and Digestive and Kidney Diseases (thyroid and pancreatic cancers).

Outside the NIH, the two major federal agencies sponsoring cancer clinical trials are the Department of Defense (DoD) and the Department of Veterans' Affairs (VA).

• 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.
• The VA conducts cancer trials at many of its medical centers around the country, which are funded through its own appropriations as well as through grants from the NCI and pharmaceutical companies.

U.S. veterans and DoD TRICARE beneficiaries can participate in NCI-sponsored cancer clinical trials as part of their health benefits. For more information, see Veterans Affairs and Department of Defense Beneficiaries.

What nonprofit voluntary groups sponsor trials?

Many foundations and other voluntary groups provide funding for clinical cancer research, including:

• The American Cancer Society (ACS)
  As of January 2005, the ACS supported 37 clinical research projects, including17 phase III randomized trials. General information on ACS research is available from its Web site and by calling toll-free1-800-ACS-2345.
• The Susan G. Komen Breast Cancer Foundation
  The Komen Foundation sponsors a wide range of basic, clinical, and translational research studies on breast cancer. From 1982 through 2004, the Foundation awarded more than 1,000 grants totaling more than $144 million for breast cancer research. In 2003/2004, the Foundation funded four projects that involved the conduct of a clinical trial. More information on the foundation is available on its Web site or by calling 972-855-1600.
• The Avon Foundation
  In partnership with the NCI, the Avon Foundation has provided funds for a grant program called the Progress for Patients Awards, which provides funding for early-phase clinical trials to develop new interventions aimed at the prevention, detection, diagnosis, and treatment of breast cancer.

How many pharmaceutical companies are involved in cancer treatment trials?

There is no simple, precise answer to this question. As with government-sponsored trials, there is no single, all-inclusive database listing all trials sponsored by drug companies.

The most comprehensive listing of pharmaceutical and biotechnology company trials is found in an annual survey on anticancer medicines under development published by the Pharmaceutical Research and Manufacturers of America (PhRMA).¹⁵ PhRMA does not limit its survey to its own members, but aims to include all drugs in development at U.S. companies and NCI. Nearly 200 companies appear in PhRMA's most recent survey.

How many anticancer drugs are being tested in clinical trials?

As of April 2005, 399 drugs were being tested in cancer clinical trials, according to the latest PhRMA survey of medicines under development for cancer treatment.¹⁶

How many of these drugs are being developed by or with support from NCI?

Out of the 399 anticancer drugs being tested in clinical trials that are listed in the 2005 PhRMA survey, 69 are designated as being sponsored by NCI.

Back to Top References

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2. Christian MC, Trimble EL. Increasing participation of physicians and patients from underrepresented racial and ethnic groups in National Cancer Institute-sponsored clinical trials. Cancer Epidemiology, Biomarkers & Prevention 2003 (suppl.):12:277s-283s. [Abstract] Last accessed July 6, 2005.
3. Albritton K and Bleyer WA. The management of cancer in the older adolescent. European Journal of Cancer 2003;39:2584-2599. [Abstract] Last accessed July 6, 2005.
4. Aapro MS et al. Never too old? Age should not be a barrier to enrollment in cancer clinical trials. The Oncologist 2005;10:198-204. [Abstract] Last accessed July 6, 2005.
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7. Tejeda HA et al. Representation of African-Americans [sic], Hispanics and whites in National Cancer Institute cancer treatment trials. Journal of the National Cancer Institute 1996;812-816. [Abstract] Last accessed February 1, 2006.
8. Hesse B et al. Trust and sources of health information: The impact of the Internet and its implications for health care providers, findings from the first Health Information National Trends Survey. Archives of Internal Medicine 2005;165:2618-2624. [Abstract] Last accessed February 1, 2006.
9. NCI Fact Book 2004. [Link to PDF] Last accessed July 5, 2005.
10. Unger JM et al. Impact of the year 2000 Medicare policy change on older patient enrollment to cancer clinical trials. Journal of Clinical Oncology 2006;24:1-4. [Abstract] Last accessed December 20, 2005.
11. Goldman DP, et al. Incremental treatment costs in National Cancer Institute-sponsored clinical trials. Journal of the American Medical Association 2003;289:2970-2977. [Abstract] Last accessed September 12, 2005.
12. Bennett CL et al. Clinical trials: are they a good buy? Journal of Clinical Oncology 2001;19:4330-4339. [Abstract] Last accessed September 12, 2005.
13. Fireman BH et al. Cost of care for patients in cancer clinical trials. Journal of the National Cancer Institute 2000;92:136-142. [Abstract] Last accessed September 12, 2005.
14. Wagner JL et al. Incremental costs of enrolling cancer patients in clinical trials: a population-based study. Journal of the National Cancer Institute 1999;91:847-853. [Abstract] Last accessed September 12, 2005.
15. PhRMA home page Last accessed August 23, 2005.
16. PhRMA 2005 Survey. [Link to PDF] Last accessed August 23, 2005.

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