Firm to aid small practices’ clinical trials

Arizona hospitals have committed more than $400 million on new cancer centers and technology in an effort to bring the most sophisticated treatment to patients.

While larger centers such as Banner MD Anderson Cancer Center and Mayo Clinic have the financial wherewithal to make large investments to woo patients, smaller physician practices that treat cancer patients don’t have comparable resources.

But now some oncologists are seeking to secure their own place in metro Phoenix’s increasingly competitive cancer-care market. They are aligning with a company that is recruiting a network of doctors who are willing to offer experimental cancer drugs and therapies to their patients.

The arrangement gives physicians and their patients access to experimental drugs through clinical trials. It also allows pharmaceutical companies a network of physicians who can administer these drugs to patients in clinical trials, which are required before the Federal Drug Administration will approve a drug for the general public.

Translational Research Management, founded by Christopher Beardmore with seed funding from biotech billionaire Patrick Soon-Shiong, seeks to ease the administrative burden of community oncologists who want to offer clinical trials to patients.

Clinical trials historically have been the territory of academic medical centers such as the University of Arizona Cancer Center, which have government-funded budgets and a roster of experienced physicians and scientists, protocols and administrative support. But private-sector organizations that tout speed and efficiency at managing clinical trials are taking a larger role in both early- and late-stage clinical trials.

While some academics question the scientific benefits of pharmaceutical-industry-funded trials at for-profit sites, the clinical-trial sites say the speed and flexibility they offer is invaluable, particularly as drug development has grown more complex in the era of genomics-based medicine.

Beardmore and physicians who oversee the clinical trials say patients ultimately benefit by getting access to experimental therapies more quickly.

“The only way we are going to get personalized medicine is to get these practitioners involved,” Beardmore said of his efforts to recruit like-minded physicians. “I will take anybody who really believes that clinical-trial participation improves outcomes. If they do, then I will accommodate them, support them and make it happen.”

A support network

Los Angeles-based Translational Research Management provides administrative and regulatory support for a network of medical, radiation and surgical oncologists, known collectively as the Arizona Cancer Research Alliance. So far, the alliance has recruited about 31 doctors and practitioners who are involved in cancer care in metro Phoenix.

Small-physician practices face many barriers to participate in clinical trials. Most small practices don’t have the time or budget to get involved, because there are have strict legal and regulatory rules.

Many community oncologists face additional financial pressures from declining reimbursement from government and private insurance companies and competition from hospital-based cancer centers. Washington, D.C.-based Community Oncology Alliance issued a report last month that showed 241 cancer clinics have closed over the past year, including five in Arizona.

Beardmore said his company handles the business functions of small practices to allow doctors to concentrate on patients. It negotiates contracts, sets budgets and manages billing and collection on behalf of the physicians.

“We take the administrative burden out of participating in research and allow these physicians to focus on the medical aspects of their clinical practice and research,” Beardmore said.

Pharmaceutical companies pay physicians and their staff for enrolling patients in the clinical trials. A physician, for example, receives compensation for screening a patient or conducting a CT scan. The physician’s practice also is reimbursed for coordinating a study and managing data.

Translational Research Management receives a percentage of the amount that pharmaceutical companies pay participating physicians.

Doctors who have joined the network include Steven Finkelstein, a radiation oncologist with 21st Century Oncology, and Michael Gordon, a Scottsdale medical oncologist and CEO of Scottsdale-based Pinnacle Oncology Hematology.

Gordon for years has offered “phase one” clinical trials for cancer patients in metro Phoenix. Phase-one trials, also known as first-in-human trials, are designed to test the safety and toxicity of drugs in humans. If drugs are determined to be safe at specific doses, they can be studied in larger trials that test how effective the drugs are at fighting a disease or condition.

Gordon said many doctors are reluctant to offer clinical trials due to the regulatory and compliance requirements.

A typical phase-one clinical trial for a cancer drug cost about $18,833 per patient in 2008, more expensive than comparable drug trials for such medical conditions as cardiovascular disease and dermatology, according to Cutting Edge Information, a Durham, N.C.-based biotech consultant.

With drug companies paying trial costs and Translational Research Management handling administrative details, Gordon said he expects more doctors will take part.

As cancer patients become more sophisticated and seek out cutting-edge treatment, some oncologists recognize that their involvement may give them access to more clients in metro Phoenix’s competitive cancer-care market.

Gordon said that clinical sites run by private groups such as Pinnacle Oncology have an advantage in speed. These sites are able to get clinical trials started more quickly than academic centers, thus getting the experimental drugs to patients and benefiting pharmaceutical companies that want to quickly test their drugs.

“Our motivation is to translate our success to benefit many patients in our community, region and state,” Gordon said. “I would love to be able to take the drugs I am developing and translate them into broader access for our Arizona patients.”

Dr. Devinder Singh, of the Arizona Center for Cancer Care, joined the research alliance to give his patients access to the latest cancer drugs and treatments. The Arizona Center for Cancer Care has locations in Glendale, Avondale, Surprise, Wickenburg and a radiation center in Peoria.

Singh’s group now has six active clinical trials for lung- and colon-cancer patients and another recently closed trial for pancreatic cancer.

He said it is important that community centers offer trials because they will reach more patients, rather than sending patients to larger hospitals in downtown Phoenix, Tucson or Scottsdale. This will allow physicians to test targeted therapies on patients with specific genetic mutations.

“The new drugs are becoming more targeted,” Singh said. “It is important we go through the community level. That is the only way we will reach a significant number (of patients) to make a dent in the community.”

Academic centers

As some private physicians are increasingly conducting clinical trials funded by drug companies, academic centers such as the University of Arizona Cancer Center focus on a different mission.

The Arizona Cancer Center is funded with a core grant from the National Cancer Institute and receives other government-supported grants. The cancer center has an annual budget of about $4 million and a staff of nearly 50 who craft budgets, conduct scientific review and provide clinical, nursing and pharmaceutical services.

The larger budgets of academic cancer centers allow them to pursue more ambitious, expensive studies that could yield discoveries that can significantly extend lives by preventing or treating cancer, according to Dr. Michael Bookman, director of clinical research at the Arizona Cancer Center.

The pharmaceutical companies may be motivated to study drugs that can achieve FDA approval, even if those drugs offer limited value for patients.

“A (pharmaceutical) company is more willing to spend resources on a trial if they are more likely to get it to the FDA” for approval, Bookman said. “Getting a few more weeks of progression-free survival is not as meaningful to patients as extending life for years or a curative treatment.”

Though academic centers can compete with private-sector practices to host clinical trials, Bookman said he believes there is room for both approaches.

He said Beardmore’s approach of providing administrative support for community oncologists may work well in metro Phoenix, where patients can choose from the likes of Banner MD Anderson Cancer Center, the Mayo Clinic, Cancer Treatment Centers of America and Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, which does phase-one trials through an alliance with TGen (Translational Genomics Research Institute).

“There are a lot of things happening in Phoenix right now,” Bookman said.

There is evidence of the competition among cancer centers. Banner MD Anderson, Mayo Clinic and Cancer Treatment Centers of America have advertised to attract patients.

Dr. Edgardo Rivera, medical director of Banner MD Anderson Cancer Center, said the Gilbert center has started its first brain-cancer clinical trial and has 10 more studies planned.

Rivera acknowledged that metro Phoenix cancer patients have many options, but he said competitive factors will not sway Banner MD Anderson’s approach to clinical trials.

Rivera said Banner MD Anderson will partner with pharmaceutical companies, but he said the trials need to have potential to make a meaningful difference for patients.

“If the motivation is to offer something for the patient, that is a real value and very appropriate to do,” Rivera said. “If this is just sort of a knee-jerk reaction, I will tell you the motivation is not the right motivation.”

Beardmore said that there is room for both academic centers and community oncologists due to the increasingly complex nature of cancer care. He expects both will thrive, and patients ultimately will benefit.

“Our goal is to make sure these patients have these (treatments) available at their bedside,” Beardmore said.