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Clinical trials: In search of better treatment - 01/29/2009

When Raffaella Barraco photographed her cluttered house, it was to document her depression.

“I actually took pictures of the house.I had to face it. Everything was out of control,” she says. By chance, she
saw a T.V. commercial in late 2007 about The Hospital of Central
Connecticut seeking participants for a depression study.

In October, Barraco, 58, wrapped up her role in that clinical trial and life has changed for the better. The Wallingford resident is one of many participants in the hospital’s varied
clinical trials aimed at improving patient care.

The basics of clinical trials
Like many teaching hospitals, The Hospital of Central Connecticut
(HCC) chooses to participate in clinical trials, focusing primarily on diabetes, endocrinology, psychiatry and cancer.
“You’re doing something to advance medicine and develop other
treatments, to potentially help people,” says Michael Balkunas, M.D.,the hospital’s chief of Psychiatry and Behavioral Health Services.

A lot of time and money is invested in the future of medicine
through clinical trials, which can last weeks to years. ClinicalTrials.gov, a U.S. government Web site, lists more
than 63,000 trials under way in more than 150 countries. Funding
sources for these research studies vary and include the federal government(many through the National Institutes of Health), pharmaceutical companies and grants. Most clinical trials have four phases. Those at The Hospital of Central Connecticut are primarily phases two and three, which study if a drug works and is safe; phase three has more participants. Phase one marks a drug’s initial testing on people, and four evaluates a drug’s
effectiveness and long-term followup.Trials are conducted simultaneously at varied institutions.

The hospital’s Institutional Review Board (IRB) reviews every
trial before it begins. The board evaluates a study’s scientific purpose and design, and works to ensure that the trial is conducted with the highest level of ethical integrity. The
IRB reviews about 25 studies annually, with approvals granted for up to one year. “The role of the IRB is to review
the design of the trial and ensure the safety of subjects,”says endocrinologist Latha Dulipsingh, M.D., who chairs the hospital’s
IRB. Members include physicians, varied hospital staff members, a minister, attorney, and one community member.

Once IRB approval is granted, study participants are sought, sometimes through advertising and/or searching through lists of current patients who might meet study requirements. Potential participants are screened and informed about the study,including risks and benefits, and those who are interested sign an informed consent form before beginning the trial.Depending on the study, participants may receive compensation, such as a gift certificate for time and travel expenses.

This trial helped diminish her own
In September 2007, Barraco became one of the last participants in a pharmaceutical company trial comparing Cymbalta, a prescription drug for depression, with a placebo,a substance that does not contain a drug, to assess energy and vitality in
depressed patients. During the preliminary study interview at HCC, Barraco recalls, “They saw that I did need help.”She
had been depressed for about 10 years, but it peaked four years ago, after she experienced some family difficulties. Her coping mechanisms began to fail. “I didn’t have control over anything,”
Barraco says.“That’s not who I was. I wanted to be who I was. I
would cry at the drop of anything.”

For the trial, Barraco took one pill daily. A double-blind study, neither she nor hospital staff knew if it was Cymbalta or a placebo. As a participant, she also came to the hospital
regularly for medical evaluation.This trial was one of about
six to eight that Psychiatry and Behavioral Health Research conducts in a year. Others focus on schizophrenia, generalized anxiety and bipolar disorders. “One of the main benefits is that
patients get excellent care,”says Balkunas, including a physical exam and related tests. For Barraco, this included a depression rating scale. Just regularly completing the depression rating scale, which asks about things like sleep and suicide thoughts, helped Barraco. “I found out what I needed to focus on and what I needed to do better,”she says.

Since it’s not known if Barraco had a placebo or Cymbalta, she continued to receive the prescription drug four weeks after the trial before being referred by staff to a physician for follow-up care. Barraco is thankful for having been part of the trial, which she is convinced helped her, even if just through the
placebo effect. Today, her homebased women’s apparel company is
thriving and she’s much more socially active. “I didn’t feel like I was worth that much. And little by little I feel
life is worth living,”she says.

Focused research on diabetes treatment
Hardly a silent disease, diabetes has marched into society at an alarming rate, with more than 23 million Americans having it.
To keep pace with the disease is research that focuses on diabetes prevention, treatment and potentially, a cure. An affiliate of the Joslin Diabetes Center in Boston — a worldwide leader in diabetes research — the Joslin Diabetes Center Affiliate at The Hospital of Central Connecticut has a dedicated
research program centering on diabetes drug treatment. “We are very involved in the clinical research component for diabetes,”says Sebastian Vassallo, the Center’s practice administrator. “It’s the bridge between aiding and caring for patients to really digging and looking for a cure.”

Diabetes is a disease defined by high blood sugar levels that can
profoundly affect the body’s functioning, due to its inability to produce correct amounts of insulin. The Joslin Center provides care for people 18 and older with Type 1 or Type
2, the more common diabetes, as well as pregnant women with diabetes. In FY 2009, the Joslin Center saw about 12,000 patients.

For more than 13 years, the center has conducted research, primarily in drug treatment phase 3 and 4 trials. It now has nine trials under way. The hospital has also partnered with Genomas®, Inc., a Hartford-based biomedical research company,
to develop new DNA diagnostic systems to help select the right
drugs and treatment for diabetics. “I believe that clinical research is a great tool to further advance our knowledge and understanding of medicine,” says Dulipsingh, director of the Joslin Affiliate and the Endocrinology and Bone Health Center.

One of the Joslin Center’s newest trials is looking at the connection between kidney disease and diabetes, a common complication since high blood sugar levels can affect the kidney’s small blood vessels that circulate sugar.
The center’s four study coordinators, all registered nurses, secure study participants and monitor their care throughout the trial. Participants visit the hospital for blood draws, complete questionnaires, and tests. By participating in the study,
people learn more about their conditions, says study coordinator
Terri McInnis, R.N., CDE, CCRC. “It’s a perfect opportunity to teach the patient and have that one-on-one contact.”

Renewed focus on cancer trials
Medicine has made great strides in treating breast, testicular and colorectal cancers over the past 20 to 30 years, says Hospital of Central Connecticut hematologist/oncologist John Delmonte Jr., M.D. But for the majority of cancers affecting adults including lung cancer, the leadingcause of cancer deaths —there’s been only mild improvement. “A lot more still needs to be done,”says Delmonte, newly named director of Cancer Research.

Working with Peter Byeff, M.D., director of the George Bray Cancer Center, he is aiming to make larger clinical oncology trials accessible to Central Connecticut residents. The hospital is seeking to affiliate with the Eastern Cooperative Oncology
Group, a consortium of institutions that designs clinical trials; and aims to resume patient enrollment in National Surgical Adjuvant Breast and Bowel Project protocols. The
hospital will also be participating in pharmaceutical clinical trials. The vast majority of cancer patients in this country are treated by private physicians, says Delmonte. “Unfortunately, a lot of these patients don’t have access to clinical trials.
They have to go to large academic institutions. This is a way to bring the clinical trials to the local community.”Delmonte recently joined the hospital from M.D. Anderson Cancer Center, Houston, where he completed a fellowship, which included designing clinical trials.

Connie Michel, 76, of Newington, is hoping her trial participation might help improve cancer treatments for other women. Michel, whose latest bout with cancer was her third, will complete a phase III ovarian cancer drug treatment trial in April. She visits the hospital every three weeks for evaluation
and to receive the trial drug. Neither she nor hospital staff knows if it is a placebo or drug. Every 12 weeks she gets a CT scan to check for tumor regrowth. “Not only am I helping myself by doing this trial, I may in some way help some other women who may come down with ovarian cancer,” says Michel.“And I’ll feel pretty good about that, too.”

She joins a niche of patients who for more than 25 years have participated in clinical trials as part of the Gynecology Oncology Group (GOG) under the National Cancer Institute. The Central Connecticut GOG is comprised of HCC, and Hartford and St. Francis hospitals. It’s directed by HCC gynecologic oncologist James Hoffman, M.D., principal investigator; and Maureen Bracco, APRN, an oncology clinical researcher at HCC. Michel has had breast cancer twice and since June has been in
remission from ovarian cancer. She’s among the nearly 30 to 40
percent of gynecologic oncology patients treated through the hospital who participate in clinical trials. The national average, according to Hoffman, is 2 percent.

Bracco says patients are regularly assessed during trials for adverse effects, which would cease a patient’s participation.“The patient’s best interest is always number one.”
“I just felt it was a booster shot to be watched that closely at my age,” says Michel of her involvement, adding her hospital visits have just slightly dented her social calendar.

Bracco says it’s exciting to be a part of the evolution in cancer treatment and patients appreciate the hospital’s desire to be in the forefront of care.“By us being very active in research they realize that we are keeping up with the most
current treatments. For them, it’s encouraging to know that their doctor is looking at new treatments.”

Questions to ask before beginning a clinical trial:

How is this going to benefit me?

What are the potential risks to me of becoming involved in a trial?

If I’m not doing well in a trial, is there a way out?

If I don’t participate in a trial, will I get the same
level of care or different care?