NEW YORKThe 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?"
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
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
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 settingshospitals, clinics, offices, and
military basesand 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.