NCI Seeks to Expand Participation in Cancer Clinical Trials

NEW YORK—The need to test new biologically targeted therapies and the presence of vocal patient advocate groups are among the factors galvanizing the National Institutes of Health to seek wider patient participation in clinical trials, Mary McCabe, RN, said during a Cancer Care, Inc. teleconference. She also made clear that patients need to ask many questions before enrolling. Only 1% to 3% of cancer patients take part in clinical trials, said Ms. McCabe, director of the National Cancer Institute’s Office of Education and Special Initiatives. "We would like to see that change," she said.

The clinical trial system has been changing drastically from the NCI’s perspective, she said, "and we would like to build on those opportunities and develop easier, friendlier systems." There are many new compounds to evaluate, and the NCI has been working in partnership with physicians and patient groups to initiate and complete trials, she said.

"We are seeing more patient-centered endpoints in trials," she said, "where the benefit is not just shrinkage of the tumor, but endpoints that are clinically meaningful for the patient. What symptoms are being reduced? What is the individual’s quality of life?"

Informed Consent: What the Patient Should Know

 The reason the study is being done.
 The potential risks to the patient.
 The length of time the patient will take part in the trial.
 The place where the patient will receive treatments and evaluations.
 The amount of time treatments and evaluations will require.
 The person in charge of the study.
 The person who will answer the patient’s questions.
 The costs beyond what the insurer will pay.
 The costs of lost wages, transportation, lodging, baby sitting, etc, if necessary.

The NCI also wants to make sure that patients get accurate information in language they can understand (see Table), she said. "Informed consent is the document that is provided. But the document should reflect a discussion that takes place between the nurse, physician, and the individual about participation and what it represents," Ms. McCabe said.

Patients should be given a list of options if they choose not to participate. If they do participate, they should be told their rights, including what is being done with their data and how their confidentiality is being protected.

Ms. McCabe advised patients to ask the investigators who is sponsoring the study and whether there is an institutional review board and a legitimate outside scientific organization reviewing the procedures and data.

Federal agencies such as the NIH, FDA, Office of Research Integrity, and the new Office of Human Research Protection are focusing on ways to identify potential conflicts of interest, she said.

"That’s becoming key as more and more trials are being done in partnership between the research community and private enterprise," she said. These agencies are also developing extensive education programs for the people who sit on the institutional review boards.

The NCI is also working to ensure that trials are being conducted by physicians in many settings—hospitals, clinics, offices, and military bases—and that there is a greater emphasis on the participation of minority populations so that the trials are more representative of the American public, she said.

The feasibility of including more elderly patients in trials is also being explored. "We’ve done some studies recently looking at the ability of elderly patients to tolerate different types of drugs and therapies, and we are finding that they can tolerate them. Cancer is, after all, a disease of the elderly, and we want to make sure that we are developing therapies that can be used with this population," Ms. McCabe commented.

Patients who do not choose to take part in clinical trials or do not qualify may have access to experimental compounds on a compassionate-use basis, she noted. If it is an NCI study, patients can call 1-800-4-Cancer and ask to speak to the pharmacist at the Cancer Therapy Evaluation Program who oversees compassionate use, or they can contact a drug company directly if it is a company-sponsored trial.

The question of whether a patient’s private insurer will cover the costs of participating in a clinical trial is a thorny one, Ms. McCabe said. "Most insurance companies have language in their contracts that says they do not pay for experimental therapies," she said, "but, in practice, most of the large, good companies will pay, especially if it is an NCI-sponsored trial."

A number of states have legislation relating to this, she said, which can be reviewed at the NCI’s cancer trials website CancerTrials.nci.nih.gov.