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Clinical Trials Move Science Forward

Sandhya Srinivas, MD
Sandy Srinivas, MD
Alan Yatagai, photographer

Buttonholing Dr. Sandy Srinivas is a challenge. She’s usually a blur of perpetual motion in the corridors of the Stanford Cancer Center. If she’s not dashing to see a patient in the urologic oncology clinic, she’s on her way to a colleague’s office or the Urology Tumor Board to confer about a cancer case.

Or she’s running across campus to meet with a group of other clinical investigators and laboratory scientists about a novel idea for a research study.

Early in her career Srinivas was unsure about her options, but she’d always wanted to work at a world-class institution where she could combine her two major interests: providing state-of-art cancer care and conducting clinical research studies to benefit more patients. She was attracted to Stanford because of its strong emphasis on “bench-to-bedside” medicine – that is, moving promising laboratory findings out of the lab and into medical treatment.

It was a good fit – Srinivas, an associate professor of medicine-oncology, has been on the School of Medicine faculty for 12 years.

“At Stanford, I am able to provide patients the highest ‘standard of cancer care,’ and with my colleagues in urologic surgery, radiation oncology, radiology and the basic sciences, think creatively about novel diagnostics, imaging and therapies for all stages of male genitourinary cancers,” she says.

Srinivas’s petite stature belies her giant passion for her patients and for clinical research. At last count she was listed as principal investigator on 19 clinical trials for prostate, kidney and bladder cancer. Seven or eight of them are actively enrolling patients, while the others are now at the stage where data are being compiled and evaluated or results are awaiting publication.

“My reason for directing clinical studies is not to be the primary author or lead investigator. Clinical trials drive science forward, ultimately to expand treatment options for our patients,” Srinivas says.

The Stanford Cancer Center is engaged in more than 250 clinical trials. Some are evaluating the effectiveness of new treatments in patients who have not responded or no longer respond to standard treatments. But clinical trials of various types are open to patients at all stages of cancer treatment.

Besides testing new drugs, clinical studies may compare diagnostic techniques; test new methods to prevent cancer or keep it from recurring; or assess quality of life for individuals living with cancer.

Many clinical trials under way at the Cancer Center are sponsored by the National Cancer Institute and other government agencies, as well as pharmaceutical, biotechnology and medical devices companies. The Stanford Cancer Center also is a member of several large study consortiums, such as the Eastern Cooperative Oncology Group (ECOG), that perform multi-center cancer clinical trials in institutions in the United States.

“But cancer clinical trials are not just about administering drugs or evaluating new techniques,” Srinivas says.

“During these studies we collect tissue, blood and tumor specimens that our basic researchers use to study the mechanisms of cancer. These specimens also may be used for additional, correlative studies, to help us decide the patients who would benefit most from the drug being studied,” she says.

Stanford’s legacy of investigator-initiated research

Some clinical studies are investigator initiated, where researchers develop and design a protocol and seek financial support from government funding agencies or the pharmaceutical industry to execute the trial and publish study results. Many significant advances in cancer research began as investigator-initiated clinical studies at Stanford:

Many rewards, a few frustrations

Sometimes, even when cancer clinical trials are available, finding enough patients to participate may be problematic. Nationally, only about 10 percent of adults with cancer – compared with over 50 percent of children with cancer – are enrolled in clinical studies.

There are many reasons for this low participation rate, Srinivas says, including a lack of information about clinical trials on the part of both patients and their doctors.

“Some patients are reluctant to volunteer for clinical trials because they don’t trust medical research, while others have poor access to quality health care or lack knowledge about clinical trials,” she says.

And, while cancer is generally a disease of aging, data from the NCI show that older patients are not fully represented in clinical trials. Only 25 percent of participants in clinical trials are aged 65 or older, although 63 percent of all cancer patients are 65 or older.

Minorities also are underrepresented in cancer clinical trials, despite the fact that many ethnic groups develop cancer more frequently than the majority of the U.S. white population.

“Greater participation, especially by older patients and minority groups, would make the group of patients in a clinical trial more representative of the broader population of people with cancer,” Srinivas says.

Srinivas and other researchers acknowledge that the only way to ascertain a new drug is safe and effective is to carry out clinical trials. But the work is often time consuming and requires meticulous documentation for integrity of research and stringent protection of patients. According to the NCI, it takes an average of almost nine years to take an anticancer drug from early-phase trials to the time it is ready for use in the clinic.

“We are grateful to have these safeguards in place, but we cannot forget that cancer patients are ill, and, by the time many come to us, they have failed to respond to standard therapies,” Srinivas says.

“Our goal is that with continued scientific progress, it will soon be possible to safely, but more quickly, get newer generations of therapy into use in the clinic – with a better understanding of who benefits from which therapy,” she says.

Posted: 3/21/09

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