Shortage of volunteers slows clinical research

By Robbie Dingeman
Advertiser Health Writer

Hawai'i medical researchers seeking cures for cancer and other diseases are struggling with a shortage of volunteers willing to take part in clinical trials that test new medicines and treatments.

A picture of health today, 10-year-old Mari Galiher participated in clinical trials when she had cancer at the age of 4. Doctors say life-saving treatments may take longer to get to the public because of a lack of volunteers for trials. Gregory Yamamoto • The Honolulu Advertiser

Dr. Brian Issell, director of the clinical sciences program for the Cancer Research Center of Hawai'i, notes that a drug called Gleevec, used to treat the relatively rare chronic myeloid leukemia, took at least four times as long to reach the public because of a shortage of volunteers willing to take part in clinical trials.

"It probably took four to five years to complete all the studies, which could have been done in one year," Issell said.

Other studies here have crept along because of a shortage of human subjects:

• A National Cancer Institute nationwide study last fall began seeking 3,600 smokers or former smokers in Hawai'i to screen them for risk factors for lung cancer. After nine months, only 1,100 had signed up.
• Two Cancer Research Center studies — on breast and prostate cancer — have each attracted only about 20 volunteers a year, though researchers were hoping for hundreds.
• Overall, only about 100 Hawai'i cancer patients participate in clinical trials each year, out of 5,000 to 6,000 new cases each year. That participation rate of 2 percent is below the national rate of 3 percent.

Hawai'i's variety of ethnic groups makes this community an especially valued test group for researchers.

However, cultural or economic factors may be part of the reason few people volunteer, officials say.

St. Francis Medical Center does outreach in Filipino dialects — Tagalog and Ilocano — to reach people who might be otherwise missed.

But Dr. William Loui, medical director St. Francis Medical Center's Mama Lau Cancer Institute, said a prevailing attitude among many Filipinos is: "I won't go to the doctor unless I'm really, really sick."

"Fear can be a factor," said Sharon Shigemasa, a nurse and spokeswoman for the Cancer Research Center. "People look at participation as being a guinea pig." And the price of treatment may be a factor, because not all insurance companies cover all costs of the trials.

Dr. Michael Carney, a gynecologist-oncologist, was surprised when he arrived in Hawai'i two years ago and found few cancer patients in his field in clinical trials. He found that patients didn't join because they didn't know about them.

Trials cover a variety of areas, from new treatments for cancer and diabetes to the effects of taking vitamins and eating certain foods.

Ten-year-old Mari Galiher of Nu'uanu is an example of the value of clinical trials. Six years ago her mother, Diane Ono, noticed deep bruises on her legs, and Mari was diagnosed with leukemia.

Ono and her husband, Gary Galiher, wanted to find the best care for their daughter, even if it meant flying her to Mainland specialists. Ono said she was surprised to learn that Mari could get the same care here through her private physician that she would at the big-name cancer clinics. Her clinical trial was administered through the Cancer Research Center of Hawai'i.

Mari's most intensive treatments put her in the hospital every three weeks for the first six months. Gradually, the treatments lessened and she was able to stop taking the medication 2 1/2 years ago. Ono said Mari still gets regular checkups that indicate she has remained free of the disease.

Leimomi Golis, 41, took part in clinical trials after receiving her diagnosis of non-Hodgkins lymphoma in 1998. Golis said the study gave her the opportunity to receive a stem-cell transplant as part of treatment. She also went through chemotherapy and full-body radiation. Golis credits the treatments with helping keep her healthy. "I had my four-year anniversary on April 21st," Golis said. "Since the transplant, I haven't had any major illnesses."

People who take part in the trials can get cutting-edge medical thinking on what might help them. And even if they end up in the standard care part of the group, they'll get more frequent check-ups than most doctors would normally be able to give them. "You'll get a lot more attention," said Dr. Carolyn Gotay, a professor in the cancer center's clinical trials program.

Other clinical trials are available through a variety of sponsors, including hospitals and organizations representing drug companies.

Private companies that do a lot of smaller studies on behalf of drug companies often have less trouble finding people to be in short-term studies, in part because participants are paid.

Paul Bogner, recruitment specialist for the local office of Radiant Research Inc., a private firm that does studies on behalf of drug companies, said it is usually able to find the smaller numbers of people it needs.

A recent ad from the company included a pitch for healthy postmenopausal women ages 55 to 80. That study required an overnight stay and offered a payment of $3,000 to volunteers who completed this study and only needed about 80 people.

Bogner said the typical payment for overnight stays is closer to $1,000. He said many of the studies look at metabolism rates of different medications and side effects. Some take just a weekend, others require returning for multiple weekends or a few follow-up visits, he said. He said people of Japanese ancestry have been a little harder to recruit for experimental studies. "They may have more reservations about participating," he said.

Bogner said it's harder to find volunteers for some studies of osteoporosis because so many people are taking some kind of medication already and are therefore disqualified.

Two of the larger ongoing prevention studies at the cancer center need more people to be more effective in learning what helps prevent breast cancer and prostate cancer:

• The STAR Study targets 19,000 postmenopausal women at high risk for breast cancer and gives participants one of two drugs — tamoxifen or raloxifene — to determine which is more effective in reducing the occurrence of breast cancer.
• The SELECT study will enroll 32,000 men who have no history of prostate cancer and is researching if taking selenium and/or vitamin E supplements can help prevent the disease. Participants may be asked to take the free pills for seven to 12 years.