When it comes to cancer treatment, Patricia Kilroe is a minimalist. In targeting her invasive breast cancer, she’s determined to undergo enough treatment, but no more.
Kilroe relied on that philosophy in December, when she was diagnosed with non-invasive ductal carcinoma in situ (DCIS) and chose lumpectomy over mastectomy. Now that an invasive lesion has been found, she’s planning the same method of attack.
This time, though, Kilroe won’t be able to avoid a sentinel node biopsy – or radiation therapy. And that’s why she’s been scanning the Internet for clinical trials offering the gentlest course of treatment she can find that still seems to promise results.
“The current standard (for radiation) is at least three weeks, if not four or five, every day. It accumulates in your body and the side effects are pretty extreme, not to mention that you’re putting yourself potentially in the path of a future cancer by having that much radiation,” says the 60-year-old. “The trials I’m looking at now involve not necessarily less radiation, but less time and, in some cases, less quantity overall.”
For the busy San Francisco professor of writing and literature, looking for clinical trials has been a time-consuming and sometimes confusing affair. Like many others who have cancer, Kilroe has found she’s largely on her own in trying to find studies she’s interested in joining, and for which she’s eligible. Her doctors have rarely mentioned the possibility — falling into a common pattern that may, researchers surmise, reflect their motivation to keep patients at their own facilities, or simply their lack of time to search through lists of studies.
PATRICIA KILROE has been using an online clinical trial matching service to seek novel treatment options for her breast cancer.
Only with the help of an online clinical trials matching service, BreastCancerTrials.org — which has guided her through “a forest of unmarked trails” — has Kilroe been able to pinpoint some promising studies. She hasn’t sought to enroll, in the past on her doctor’s advice and now because she’s still exploring what’s available, but she’s been grateful to have help in narrowing the field.
“It is worth pursuing, because I want what’s going to be the standard of care, not what is the standard of care,” she says. “I’m not as trusting as somebody else might be that the standard of care is the best and only course of action.”
Luckily for patients like Kilroe, assistance in finding trials of cancer treatments is becoming more plentiful; it’s now being offered by about 30 clinical trial listing and matching services that are available online, at no cost to individual users. The less complex listing services, such as those on the websites of pharmaceutical companies, are basically lists of trials that give patients a general idea of whether they might be eligible based on their age, gender and type of cancer; but others match patients based on very specific personal and disease characteristics and geographic location, even making navigators available by phone or email to provide guidance.
For many traveling the road of cancer treatment, experts wager, these services represent the most effective way to get connected with clinical trials. Once patients have found studies that look promising, they can initiate conversations with their doctors, and/ or directly with the study teams.
“Taking the step to do that research — to make sure that all the options are explored, and to think about a clinical trial through all phases of the treatment spectrum — is definitely encouraged. And a service that might be able to sort through this morass of information to find trials that might be relevant to a particular patient is probably the most valuable aspect,” says Matthew Galsky, associate professor of medicine, hematology and medical oncology at Mount Sinai Hospital, in New York, who has studied barriers to clinical trial enrollment.
“Rather than relying on these services to find the trial that’s necessarily the one to help the most,” Galsky suggests, “the biggest benefit is from understanding what the options truly are based on the trials that are really matched to a patient’s particular disease state at that time.”
A Long-Lived Idea
America’s most comprehensive, searchable listing of clinical trials is ClinicalTrials.gov — sponsored by the National Institutes of Health — which in early May offered information about nearly 190,000 trials being conducted in 90 countries. But searching that site can be tricky.
“The great thing about ClinicalTrials.gov is that, because of some legislation, registration (of most trials) is mandatory, so it is a comprehensive listing. The downside is that it’s incredibly difficult to navigate, even as a physician when you know what you’re looking for,” Galsky says. “It’s even more difficult for a patient who might not know the proper terminology or what disease state they should be searching for. We get queries by email all the time from people interested in one of our trials, only to learn that the patient has much earlier-stage disease (than that being sought by investigators), or that the trial is completely not applicable to their current disease state.”
That, he says, demonstrates why matching services are needed. It may also explain why such services rose from the dust after many of them disappeared a couple of decades ago.
“These services have been around for 20 years, and their number is not that different than it was during whole dot-com craze in the mid to late ’90s, but many of those didn’t survive the dot-com bubble bust,” says Ken Getz, an associate professor at the Tufts Center for the Study of Drug Development and founder and owner of CenterWatch, which provides a listing service and clinical research news. “As of late, we’re seeing a lot of new services that are doing a very sophisticated thing with a wealth of data online, and using some method of geographic location.”
CenterWatch was founded at the start of the trend and survived uninterrupted through the bust. The company’s database of 80,000 studies includes industry-funded trials not listed on ClinicalTrials.gov, as well as studies from the government-sponsored site.
“We have about 30 percent to 40 percent of all industry-funded trials, and that includes early-stage as well as later-stage trials,” says Getz. Patients can search by medical condition, therapeutic area or geographic location. Listings include the names and telephone numbers of principal investigators.
In addition, CenterWatch offers a free notification service that will email patients, if they’ve created an account, when a trial matching their requirements is registered.
Varying Models, Similar Goals
Kilroe started her own search by visiting ClinicalTrials.gov, but soon found herself feeling confused as she realized “it was hard to know which of these trials fit me.” She was directed toward BreastCancerTrials.org by a friend with a medical background.
It was exactly Kilroe’s dilemma that Joan Schreiner and Joanne Tyler hoped to resolve when they conceived the idea for BreastCancerTrials. org in 1999. Both patients with metastatic breast cancer, the women wanted to make the trial search easier for people like themselves.
Together with UCSF Breast Care Center investigators Laura Esserman, Debu Tripathy and John Park, they built a prototype at the institution, which operated as a National Cancer Institute/UCSF research project from 2005 until 2008, when it launched nationwide. The site currently operates as a program of QuantumLeap Healthcare Collaborative, a nonprofit organization affiliated with UCSF, providing users with up-to-date information on more than 600 breast cancer-related trials.
Only trials registered on ClinicalTrials.gov are included, but each trial description is rewritten to make it easier for patients to understand. Patients can use the service simply to browse or, by setting up a profile, can find – and be alerted about — trials matched to their tumor types, biomarker status, treatment histories, geographic areas and more. And they can use the site to contact trial investigators directly.
Around the same time that the founders of BreastCancerTrials.org were devising their idea, EmergingMed appeared on the scene. Since then, it has seen more than 320,000 patients fill out detailed questionnaires in hopes of getting matched to trials. The site features the entire national database of trials for each disease type, curating information from ClinicalTrials.gov, medical centers, advocacy groups and trial sites and sponsors.
“For example, EmergingMed has over 780 studies available to breast cancer patients in the United States and Canada. EmergingMed manages a national database of Alzheimer’s disease and dementia trials for the Alzheimer’s Association, and 25 percent of the trials in the database are not in ClinicalTrials.gov,” says Courtney Hudson, EmergingMed’s CEO and co-founder.
More is Better
It’s that model of creating tailored search sites for clients that supports EmergingMed and enables its free use by individuals. The company hosts its national database, matching service and concierge support for about 60 paying clients – advocacy groups, cancer centers and pharmaceutical companies — with customization to meet their needs. Even though customization allows clients to highlight the trials it sponsors, EmergingMed is designed to ensure that matching is unbiased for patients who use the service, Hudson says. On a first search via a customized service, patients might net an incomplete number of relevant trials, she says, but they can then, with one click, continue on to query the full national database of trials.
While EmergingMed’s model differentiates the site from nonprofits like BreastCancerTrials.org, it’s OK for patients to use either kind.
“It doesn’t matter anymore, because plenty of .coms have .org in their name – it’s not as reliable a screening as before, and, frankly, a lot of the .orgs may have far less content or information than the .coms,” Getz says. “As a patient, you want to be able to gather as comprehensive an information set as possible, and go to multiple sources.”
In fact, the idea of using more than one search engine to research clinical trials can’t be emphasized enough, Getz and Galsky agreed.
“Let’s say a major pharma goes to a (matching) service and says, ‘Here are six of the more than 200 trials we’re conducting; we want you to direct patients to these six,’” Getz says. “There may be a benefit to that, but I’d suggest that patients must be aware that they are not (necessarily) being matched to the universe of trials, but only to a selected number. Therefore, you should never just go with a single matching service. You need to try to broaden the resources you’re using to help you find a trial that may be right for you.”
Once a patient has succeeded in finding trials that look promising, Getz cautioned, the work isn’t nearly over.
“Some of the services will match, but don’t give a lot of information patients can use to evaluate the trial,” he says. “Patients then need to go to the research center, contact them for more information about the study and go through a more elaborate initial screening to see if they qualify for the trial. Patients have to self-advocate, do hard detective work and compile a list of potential trials to evaluate with their health care provider.”
The Best Kept Secret
While Kilroe is happy with the care she’s received from her health care provider, she would have felt a lot more supported, she says, if the provider had designated someone to answer her many questions and offer her information about the whole scope of potential care – including clinical trials.
Apparently, it’s not an uncommon concern. One of the main reasons that just 3 to 7 percent of patients with cancer enroll in clinical trials is that their doctors don’t mention studies as an option, or only mention trials that are enrolling at their own institutions, Getz and Galsky say.
“There’s anecdotal evidence that suggests that some physicians are worried about losing a patient to another specialist or care provider,” says Getz, who, with colleagues at Tufts University, is studying the issue. “Some argue that physicians don’t have the time to evaluate this information and make a referral with confidence.”
Alternatively, Galsky says, doctors might feel that a patient needs immediate treatment, and not want to wait out a trial enrollment process. Or “they might feel that the trial, while asking an important question, has a low likelihood of helping that patient directly,” he says.
Even when patients are fully aware that trials are an option, and have a means of finding some that look promising, they may face barriers to enrollment, Galsky continues.
“Trials are designed to enroll a very specific patient population, and that’s often done for safety reasons,” he says. “But at the same time, that pendulum has swung a little too far in the opposite direction. Trials are so restrictive that the vast majority of patients aren’t eligible — for instance because they have other medical problems or had another cancer in the past.”
Some patients many not want to travel, so the location of trials far from home can also be an issue.
Ultimately, these concerns affect not only patients, but investigators trying to develop treatments. A study Galsky conducted found that, of 8,000 clinical trials of cancer treatments launched over five years, 20 percent couldn’t be completed due to lack of enrollment.
The jury’s still out on whether clinical trial matching services are helping to close that gap.
Hudson, of EmergingMed, points out that about 26,000 of the cancer patients who have used its service have contacted trial sites to learn more. “Nearly 80 percent of people who find a match and talk to one of our clinical trial navigators contact a trial site,” she says.
Directors of a search engine run by the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP) have found that 40 percent of those matched with trials by the site actually contact investigators; CenterWatch, meanwhile, has found that, of the nearly 250,000 patients and supporters who use the site to review trial listings each month, about 30 percent contact trial sites for follow-up information.
Finally, in a 2013 survey of people who subscribed to BreastCancerTrials.org’s Trial Alert Service, 50 percent of respondents reported that they took an action based on the information they received on the site. Thirty percent of those did so by contacting a research site, and, of that group, 40 percent enrolled in a trial, says Elly Cohen, program director for the matching service and an assistant professor of surgery at UCSF.
“If you ask the companies, they say yes, and research sponsors say that, in some cases, it has helped,” Getz sums up. “But in many cases, they can’t answer that question.”
I agree with the author's listing of the barriers to finding and participating in a clinical trial. One not mentioned though is the financial cost to the patient. I incur all out of pocket expenses, such as a weekly 250 mile round trip car ride, finding and sometimes paying someone to drive me, occasional hotel stays so I can be at the hospital for a 7am blood draw, insurance co-pays for what is deemed "routine or standard of care". (In my case, my insurance covers 90% at my home hospital and only 80% at the study hosp.)
It is an investment in my future, but not everyone can afford that. The study coordinator recently hooked me up with the Lazarex Foundation (lazarex.org) and they will be helping me with some of the trial travel expenses.
Also, now disabled because of my disease and the # of rounds of chemotherapy and how weak it has left me, does give me the time to commit to a 6-month, weekly treatment trial. I must say, i'm not sure I would have done it if I was still working.
Is anyone aware of a particular search site for patients with ovarian cancer?
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