1. What is a clinical trial?

In cancer research, a clinical trial is a study of how a particular intervention--for instance, a treatment or a preventive measure or a way of diagnosing cancer--affects the people who receive it. The rules on how the intervention is given are specified in advance in a document called a protocol.

2. Which clinical trials are covered by the NCI/VA agreement?

The agreement covers the full range of NCI-sponsored clinical trials, including prevention, diagnostic, and treatment studies. Prevention clinical trials look at lifestyle changes or drugs that may help prevent cancer. For example, NCI trials are now testing drugs that may prevent breast cancer in people at high risk. Diagnostic clinical trials look at ways of detecting cancer or finding out more about a tumor. One current NCI trial, for example, is looking at new ways to analyze Pap tests for cervical cancer. Treatment clinical trials may study new drugs or other ways of treating cancer, or they may look at new combinations of established treatments. Included in the NCI/VA agreement are phase I treatment trials, which test the safety of a treatment; phase II trials, which determine whether a treatment is effective in various kinds of cancer; and the larger phase III trials, which compare a widely accepted or "standard" treatment to a new treatment that appeared promising in phase II studies. One example of a current treatment trial is a phase II study of the drug taxol in combination with cisplatin to treat advanced or relapsed lung cancer.

3. Which trials are defined as "NCI-sponsored"?

NCI-sponsored trials, for the purpose of the agreement, are:

• Trials reviewed and approved by NCI staff;

• Studies conducted by NCI cooperative clinical trial groups, which are networks of institutions that jointly carry out large clinical trials following the same protocols;

• Studies conducted in clinical and comprehensive cancer centers under an NCI-approved protocol review and surveillance mechanism; and

• Protocols performed under the direct support of an NCI peer-reviewed grant.

4. Which veterans are covered by the agreement?

Veterans covered are those who fall into the "mandatory" category under legislation passed by Congress. These include:

• Service-connected veterans (those with a VA determination of a service-related health problem);

• Former prisoners of war;

• Veterans who were exposed to herbicides while serving in Vietnam, to ionizing radiation during atmospheric testing and during the occupation of Hiroshima and Nagasaki, or to an environmental hazard while serving in the Persian Gulf Theater and need treatment for a condition that might be related to such exposures;

• Veterans receiving a VA pension;

• Veterans of World War I;

• Veterans eligible for Medicaid; and

• Veterans who are nonservice-connected and whose income is $21,001 or less if single with no dependents, or $25,204 or less if married or single with one dependent, plus $1,404 for each additional dependent.

5. Where can veterans enroll in NCI clinical trials?

Veterans will be able to enroll in trials at participating VA facilities and, in selected cases, in non-VA institutions. VA will define the circumstances under which patients will enroll in trials in non-VA facilities.

• VA Medical Centers
  Fifty-two of the 173 VA medical centers around the country are already affiliated with NCI's cooperative groups, the networks of institutions that carry out joint clinical trials. More are expected to join the NCI cooperative groups as a result of the agreement. In addition, some VA medical centers that are affiliated with major academic medical centers are already participating actively in NCI-sponsored early clinical trials of new agents. This agreement calls for more extensive participation in the early clinical trials program by VA.

• Non-VA Medical Centers
  Under special circumstances, such as trials of particular importance to VA or trials of rare tumor types, VA may offer mandatory veterans access to NCI-sponsored clinical trials in non-VA facilities.

6. How do veterans and their doctors find out what trials are enrolling patients and where they are located?

NCI maintains a database of clinical trials as part of its Physician Data Query (PDQ) system. PDQ provides comprehensive information on NCI-sponsored trials enrolling patients throughout the country. The database is updated monthly and provides the latest information on eligibility for clinical trials as well as physicians and hospitals participating in the trials. NCI is adding a feature to PDQ that will let users search by VA facilities and the specific trials in which the facilities are participating. Patients and the general public can call 1-800-422-6237 (1-800-4-CANCER) to request a customized search of PDQ. Callers can ask, for example, for a search specific to a geographic location or a certain mode of treatment, as well as to the type of cancer and stage of the tumor. Health professionals can call the PDQ Search Service at1-800-345-3300 to request a customized search or they can send an e-mail to pdqsearch@icic.nci.nih.gov. In addition, NCI has developed a World Wide Web page on the Internet that allows any user to search the PDQ database directly (http:\\cancernet.nci.nih.gov).

7. What other joint activities does the agreement establish?

NCI and VA also will establish closer cooperation in planning future trials and in addressing economic research questions, including cost-effectiveness evaluation.--an NIH HEALTHWise report, February 1997