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The Research Phase


Posted on February 2, 2016

Clearing up misconceptions about clinical trials can make the difference in finding new ways to treat disease.

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Zane Jochim of Lodi joined a UC Davis clinical trial testing two forms of chemotherapy for his lung cancer, hoping for some good to come out of it, either for himself or someone else. 
Photography by Carl Costas

By his own account, Zane Jochim of Lodi had “a lot of time to think” after being diagnosed with non-small cell lung cancer in late May, 2015. Having lost a few family members to other forms of cancer, Jochim knew what could lie ahead. So when his doctors at UC Davis Comprehensive Cancer Center presented him with an option to participate in a clinical trial involving two forms of chemotherapy, he decided to give it a shot. “If it does me some good, great. Otherwise, it will do someone else some good,” he says. “They’ve gotta find some better treatments for cancer, and the only way they will find them is through trials.” 

Jochim’s lung cancer is just one of thousands of diseases and disorders getting special treatment, so to speak, through clinical trials, a process by which new approaches to patient care are evaluated. And while 2013 data from The Center for Information and Study on Clinical Research Participation shows that more than 90 percent of North Americans understand what a clinical trial is, local research facilities report that they see low participation rates among minorities and women. “Without the participation of a variety of individuals, we’re not going to be able to answer definitive questions if we don’t have a sample that reflects the end user of that treatment,” says Linda D. Marks, director of operations, office of clinical research, at Sutter Institute for Medical Research. 

Through building awareness of how clinical trials work, more consumers may be willing to consider participating in one and helping to advance medical care. With that in mind, here are five facts you may not know about clinical trials, along with information about current studies going on locally. 

FACT 1: IT’S NOT ALL ABOUT NEW DRUGS. News stories often report the results of clinical trials for prescription drugs. However, in the same way that there are many different ways to treat medical conditions, several kinds of clinical trials exist. Screening and diagnostic trials strive to find new methods for identifying early indicators of diseases and disorders. Trials of medical devices or surgical procedures can look at new technology, techniques, both, or a combination of traditional treatment methods with new tools. Quality-of-life trials investigate ways of caring for patients with chronic conditions. Marks says quality-of-life studies are often used by hospitals and medical centers to improve internal procedures and caregiving methods. 

Some trials involve testing an FDA-approved drug for a new purpose, either alone or in combination with other treatments. Cancer clinical trials can focus on using treatments with a good track record against one form of cancer on a different form of cancer. For example, Primo Lara, M.D., an oncologist at UC Davis Comprehensive Cancer Center, is spearheading a trial featuring an immunotherapy drug effective in treating lung cancer and melanoma on chemotherapy-resistant bladder cancer. 

FACT 2: PARTICIPANTS DON’T HAVE TO PAY. Those wondering who pays for clinical research, rest assured that participants pay nothing. Clinical trials can be funded or sponsored by a variety of means. Federally funded trials take place at the Bethesda, Md., headquarters of the National Institutes of Health, the federal government’s main biomedical research facility; NIH also sponsors research at universities, medical schools, hospitals and private institutions throughout the United States. Institutionally sponsored trials are funded by private sources, such as Sutter Institute for Medical Research. Lastly, industry-sponsored clinical trials are paid for by corporations; pharmaceutical and medical manufacturing companies fall into this category. 

But what about any medications, doctor visits and lab work that come with being in a clinical trial? Will insurance pay? It depends. Sponsors often cover the cost of treatment, but coverage for routine patient costs, such as office visits and screenings, can be less clear. The Affordable Care Act says a qualified individual who participates in an approved clinical trial cannot be denied coverage of associated routine patient costs. In California, for patients who participate in certain approved cancer treatment trials, health plans must pay for routine costs. Before deciding whether to participate, consumers should discuss coverage issues with their health care provider and health plan administrator. 

FACT 3: A VIGOROUS REVIEW PROCESS PREVAILS. Before clinical trials even begin recruiting patients, researchers and institutional review boards work to ensure positive outcomes. “We make sure that the trial is highly likely to succeed and has strong potential in improving patient care,” says Andrew G. Hudnut, M.D., medical director for Sutter Institute for Medical Research. “We only offer a clinical trial if we think it will improve care or answer questions.” All clinical trials have protocols, a written guide on how to conduct the research, and clinicians are responsible for ensuring the protocols are followed.

To join a clinical trial, patients are pre-screened, which includes interviews with researchers and clinicians, laboratory testing and other factors, all to ensure that the patient is a good candidate. Once accepted into a trial, patients work with a coordinator who manages all the details—a luxury when dealing with a challenging diagnosis. Folsom resident and cancer survivor Cindy Baumeister praises the work of the patient coordinator who has guided her through two different clinical trials. “She gives me a calendar with all the doctor appointments, labs and scans already scheduled—I don’t have to manage any of that,” she says. Hudnut says patient coordinators play a key role in ensuring a trial’s success. “The excellence of the data [gathered] is built in part upon the relationship and communication between patient and coordinator,” he says. “The coordinator provides a lot of knowledge, support and access.”

FACT 4: PATIENTS CAN BAIL OUT ANY- TIME. Participants have many rights, and the freedom to leave a trial at any time is among them. During initial screenings, researchers and coordinators state the risks, possible side effects and possibility of receiving placebos. “Patients need to feel comfortable that research is about answering our ignorance,” says Hudnut. “Sometimes we haven’t improved an outcome, and patients need to feel comfortable with ambiguity.”

In cancer clinical trials, however, everyone wins: No patient goes without treatment if one is known to be beneficial, and a trial will end early if a treatment is found to be harmful or ineffective. According to the UC Davis Comprehensive Cancer Center website, “if it becomes clear during a clinical trial that one treatment is better than another, the trial is stopped and all patients in the trial are offered the more effective treatment.”

FACT 5: IT’S UP TO PATIENTS TO START THE CONVERSATION. While doctors participating in research at UC Davis Comprehensive Cancer Center and Sutter Institute for Medical Research will recruit from their patient rosters, other physicians may be unaware of what clinical trials are available. It’s then the patient’s responsibility to seek out relevant clinical trials. Online resources such as clinicaltrials.gov are a good place to begin. If an appropriate clinical trial is available, Baumeister recommends lots of talking: “Talk to other folks in clinical trials, talk to family members, friends, talk to your [doctor].” For tips on how to talk to your health care provider about clinical trials, visit the Patient Advocate Foundation website at patientadvocate.org.

Even if the idea of participating in a trial is daunting, the potential of a positive outcome inspires many to take the chance. Finding out that her ovarian tumor had shrunk to 57 percent of its original size after 18 weeks was tremendously encouraging for Baumeister. “When you hear results like that, it’s the reason why you do clinical trials,” she says.


Currently Recruiting: Local Clinical Trials

 

UC DAVIS COMPREHENSIVE CANCER CENTER (916) 734-3089

Bladder Cancer: Feasibility Trial of Pembrolizumab + Docetaxel or Gemcitabine in Platinum Pre-treated Urothelial Cancer. This trial for patients who already have failed chemotherapy treatment uses chemotherapy in combination with an immunotherapy called pembrolizumab, a checkpoint inhibitor that has been used to treat lung cancer and melanoma.

Breast Cancer: Hormone Therapy With or Without Everolimus. This randomized, placebo-controlled trial will evaluate the use of adjuvant endocrine therapy with or without everolimus in patients with high-risk, hormone receptor positive and HER2/Neu negative breast cancer.

Lung Cancer: Atezolizumab and Stereotactic Ablative Radiotherapy in Patients With Non-Small Cell Lung Cancer. This trial compares administration schedules of the immunotherapy drug atezolizumab plus stereotactic radiotherapy in patients with stage IV lung cancer. 

SUTTER INSTITUTE FOR MEDICAL RESEARCH Patient Recruitment Services: (877) 494-3444; Clinical Trials: (916) 733-8930

Alzheimer’s Disease and Mild Cognitive Impairment: Studies seek male and female participants with diagnosis of Alzheimer’s (ages 55–84) or mild cognitive impairment (ages 50–85) who have a support person who is willing to attend all study visits with them. Contact: Tammy Donnel, (916) 453-5994.

DIGNITY HEALTH (877) 778-7755

Cardiovascular: The Partner II trial of the Sapien XT and Sapien 3 aortic transcatheter valves offers patients with aortic stenosis (narrowing of the aortic valve)—and for whom traditional valve surgery is too high risk—less invasive treatment options for aortic valve replacement.

Lung Cancer: The Lilly Juniper trial is for patients with previously treated lung cancer with a KRAS mutation who have progressed after standard platinum-based chemotherapy. The study randomizes patients to either the investigational drug abemaciclib, plus best supportive care, or to the standard oral drug erlotinib, plus best supportive care.

KAISER PERMANENTE kpstudysearch.kaiser.org

Asthma: This observational study will evaluate predictors of response to Xolair (omalizumab) in patients with moderate to severe asthma.

Parkinson’s Disease: This study will evaluate the safety and effectiveness of the Boston Scientific implantable deep brain stimulation Vercise system for bilateral stimulation of the subthalamic nucleus as an adjunctive therapy for improving the number of waking hours per day with good symptom control and no troublesome dyskinesia in adults with advanced, levodopa-responsive bilateral Parkinson’s disease that is not adequately controlled with medication.

 

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