Clinical trials, aka research trials to test new or improved treatments, are widely accepted as the way to progress in establishing new standards in cancer therapies while simultaneously affording state-of-the-art care for patients.The problem: low participation in general, with less than 5 percent of adult cancer patients joining clinical trials. The percentage is even worse among people who are part of minority populations.The reason: barriers that make enrolling difficult if not impossible.“Most patients will never participate in trials, even though most would say ‘yes’ if asked,” says Mark Fleury, PhD, policy principal on emerging science for the American Cancer Society Cancer Action Network (ACS CAN) and leader of its clinical trials portfolio.“At ACS CAN, we’re working on policies to reduce barriers systemwide,” Dr. Fleury says, pointing to an action blueprint in the organization’s 2018 landscape report.Meanwhile, Fleury says, would-be trial participants can act on their own behalf to overcome the most well-known barriers.Barrier #1: The Awareness Gap“People with cancer aren’t generally aware that clinical trials exist, that they may be eligible to participate, that various support services can assist them in participating, and that it’s within their power to ask,” says Andrew Poklepovic, MD, associate director for clinical research at VCU Massey Cancer Center in Richmond, Virginia.Doctors, for their part, may not be aware of patients’ interest in clinical trials, Fleury says, adding, “Because the information isn’t easily available, they may not know about trials at their own institutions. And they often lack staff, bandwidth, and processes for exploring what’s available off-site.”How to Get Around ItAsk about clinical trials. Now that you know the problem, ask your healthcare team — ideally upon diagnosis — about trials available to you at different treatment stages. Another good time to ask: if a prescribed treatment plan fails. Asking can prompt doctors to regard patients as partners in their cancer care and to search for appropriate trials, Dr. Poklepovic says.Ask for a referral. If a doctor or local institution can’t help you navigate the trial landscape, ask for the name of an academic medical center or major practice group within driving distance, where there’s likely to be someone who can.Check out clinical trial data bases and matching services. Government-sponsored, third-party, and disease-specific sources listing cancer trials may also offer skilled navigators to help callers or website visitors match their medical profiles with trial-eligibility criteria. Here are some links to get you started:Government-Sponsored Trial Finders Third-Party Trial FindersDisease-Specific Trial FindersAny reputable advocacy or support group or foundation supporting research into your cancer may also link to clinical trials and trial navigators.Barrier #2: Navigating Eligibility CriteriaDepending on the trial protocol, any part of your medical profile or treatment history may create an obstacle to joining. But what many don’t understand is that there are workarounds, experts say.How to Get Around ItExplore bending or waiving criteria. Since kidney function, for example, can vary weekly, ask to be retested and submit new results. If other health conditions (comorbidities), such as hypertension and diabetes, make you ineligible, ask if the requirement can be waived. “If a condition is under control, it may make no difference to the trial’s outcome,” Poklepovic says. Ditto for “performance status” (how independently active and ambulatory a patient is).Word to the wise: Poklepovic tells people to stay as active as possible for as long as possible, which will make people more likely to qualify for trials. And if you do get turned down based on eligibility criteria, Fleury advises asking about having your eligibility reconsidered if things change moving forward. “Ask if your current treatment stops working, might you then qualify?” he says.Barrier #3: TravelNot all trials will take place within a convenient driving distance or an easy flight. A trial’s inconvenient location can pose significant hurdles to participation for some.How to Get Around ItDiscuss technologies and other tools that might reduce time and travel demands. These include giving patient consent virtually, submitting health data using remote-monitoring devices and wearables, and seeing doctors via telehealth visits for routine check-ins. “Ask, too, about a local health team routinely collecting blood and other samples,” says Fleury.Barrier #4: Medical Costs/Insurance CoveragePeople often reject trial participation because they think that it involves costs (for extra services and tests, copays, and deductibles) not covered by the trial or insurance, according to the ACS CAN report.The reality is that Medicare and Medicaid are required to cover “standard of care” costs (i.e., people’s routine cancer treatments), including those associated with complications experienced during a trial. But private insurers, who are mandated by the Affordable Care Act to cover routine care within cancer trials, may insist that those services be “in network” — a major issue for trials at out-of-network facilities.How to Get Around ItConfirm what the trial covers.Confirm what insurance covers. Query in-network restrictions.Ask the trial coordinator whether routine services can be performed by non-trial, in-network staff.Seek assistance to bridge the coverage gap. Many cancer-specific organizations, such as the Leukemia & Lymphoma Society, link to financial resources. So do many cancer and patient-centric nonprofits, including these:Barrier #5: Nonmedical CostsNot all costs are copays. “Travel, parking fees, $4 cups of coffee at hospital cafeterias, overnight housing — ancillary costs add up to a huge participation barrier,” Fleury says. “People have stopped cancer treatments because of nonmedical expenses.”Some clinical trials will reimburse these costs. Others won’t, citing anti-kickback regulations aimed at preventing payoffs for trial participation. (Ongoing legislative efforts are trying to clarify that ancillary cost reimbursement isn’t a kickback.)How to Get Around ItBarrier #6: Connecting With Clinical Trial Teams“We hear a lot about people spending hours trying to find the right person to talk to about joining a clinical trial,” Fleury says. The frustration, he says, “stops people cold.”How to Get Around ItRecruit an experienced ally. Many medical institutions and cancer centers have patient advocates or clinical trial navigators. Cancer-specific organizations (e.g., the Leukemia & Lymphoma Society) often have staff experienced in contacting trial coordinators and assisting enrollment.Barrier #7: FearMany people say no to trials, ACS CAN reports, because they fear its riskiness (side effects, adverse outcomes) and, particularly, a loss of control over their own therapeutic plan. “People hate ‘randomization’ — being randomly assigned to a treatment, as well as the idea of being given a placebo, which doesn’t happen, since everyone receives the standard of care,” says Fleury.How to Get Around ItCommunicate all concerns to program administrators.Ensure that they explain a trial’s ethical and regulatory guardrails. These guarantee that no treatment will likely be worse than the other.

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