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CURE COMMUNITY
How do we improve cancer clinical trial participation?
BY ELIZABETH WHITTINGTON | JUNE 5, 2009
Nearly 1.5 million people will be diagnosed with cancer this year, but only 3 to 5 percent will enroll in a clinical trials testing new cancer therapies. At this year's annual meeting of the American Society of Clinical Oncology, physicians, researchers, and industry officials gathered to discuss why few patients enter clinical trials and possible solutions to increase that percentage.
While patients' reasons for not entering clinical trials are commonly cited--fear of getting a placebo, not understanding the trial, potential out-of-pocket costs, or fear of being a "guinea pig,"--the session also covered why many physicians don't discuss clinical trials with their patients and other stumbling blocks to clinical trial enrollment.
Two interesting points came up in the talk: Many physicians do not bring up clinical trials to their patients, and strict eligibility requirements prevent many willing patients from entering clinical trials.
Two reasons given why physicians do not offer clinical trials to their patients were lack of knowledge regarding specific clinical trials to offer and discomfort in talking with their patients about clinical trials. In a 1991 survey cited during the session, 55 percent of physicians questioned said they were uncomfortable discussing clinical trials with their patients. Hopefully, this has improved since then.
Communication may also be an issue. In a 2008 survey, 14 percent of patients who were offered a clinical trial reported they were not offered one--obviously more than just chemobrain. Physicians must communicate better with their patients to make sure they understand the clinical trial being offered and the process.
Once doctors interest their patients in clinical trials, strict eligibility requirements may still prevent them from enrolling. Some trials may have restrictions on age or call for a specific disease stage and subtype. Often patients could not have had a prior treatment of this or that or within a certain timeframe. Sometimes measurements of heart function or blood counts have to be in a specific range. For these reasons, and many more, many patients are excluded from trials. The panel at the ASCO session suggested that maybe some of these eligibility requirements could be a little more flexible, which may allow the clinical trials to reach accrual sooner. To drive this point home, there are studies testing promising treatments or combinations that are closed every year due to slow accrual of patients.
Some survivor suggestions from Twitter (www.twitter.com/cure_magazine) echoed many of the panel's suggestions, including allowing minor exceptions for trial eligibility and better communication between patients and doctors about clinical trials. Empowering patients to find trials, including using a matching system where patients are notified of studies they would qualify for, could help patients bring up the topic with their oncologist.
Fortunately, there are several websites that allow patients and survivors (and even people without a cancer diagnosis) to find clinical trials, in addition to http://www.clinicaltrials.gov and www.cancer.gov/clinicaltrials/search.
TrialCheck (www.CancerTrialsHelp.org), a site sponsored by the Coalition of Cancer Cooperative Groups, not only provides information about the clinical trial process, but also allows a patient to search for trials they qualify for by answering a questionnaire about their cancer type, stage, and other information. It also allows patients to save their searches and set up a notification system to alert them when new trials open.
Similarly, the Army of Women (www.armyofwomen.org), a site sponsored by the Dr. Susan Love Research Foundation and the Avon Foundation, is actively recruiting one million women for clinical trials focused on finding the causes of breast cancer and how to prevent it. The site provides a way for researchers to reach out to women interested in participating in these trials. Women who are not currently undergoing breast cancer treatment can sign up on the site and are then notified of select clinical trials, allowing them to choose whether to enroll or not. To date, the site has reached more than a quarter of its recruiting goal after launching in October 2008.
For more on clinical trials, read "Before Treatment: Understanding Clinical Trials" from CURE's 2009 Cancer Resource Guide at http://www.curetoday.com/index.cfm/fuseaction/article.show/id/2/article_id/1016.
Poll: Did your medical team discuss participating in a clinical trial with you when you were diagnosed? Click here to take poll
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After Sutent failed for my husband's Stage 4 Renal Cell Carcinoma, he was offered a clinical trial. He sat for an hour going over all the possible side effects and signing papers. The NEXT DAY, they called to say that he was ineligible for the trial. The reason? The Sutent they put him on in the first place!! We looked into clinical trials, but none were taking place near where we live, and we can't afford to travel. I think it's a problem when the doctors aren't well-versed in the trials, the eligibilty requirements, or recommendations. It's a shame that so many trials seem limited to certain areas, or even countries!
- Posted by annieb 6/11/09 5:31 PM
I would like to make a couple of comments here. As a former cancer patient and working in the pharmaceutical research field, I have a somewhat unique perspective.
First, I asked about clinical trials at diagnosis. A brachytherapy trial was going to begin at my treatment center but they had a local IRB and we all knew that I could not wait until the protocol was approved by the (usually slower moving) local IRB. That knocked out one trial.
I had triple negative breast cancer-not much was available at the time of my diagnosis-Nove/Dec 2005. I wasn't eligible for what was available. That didn't bother me as I know from my paid work that inclusion/exclusion criteria are strict for good reasons. Had anything been available for me, I already knew that I would not participate in a trial that gave me more than a 50% chance of receiving a placebo and, further, my first choice would be a new treatment compared to standard treatment. First choice because the placebo issue would not have been in play.
What was available was a study investigating the reasons women gained weight on chemo. By the time I became aware of that, honestly, the visits required felt like one more "thing" to do. One more item on my cancer list. I often said I felt like I had another full time job due to the need for pre-chemo testing: MUGA scan, DEXA scan, blood work, chest plates, etc. I just did not have the energy to go to one more doctor's appointment/talk to one more person, etc.
Initially, I felt guilty about this but decided after about 5 minutes of guilt that I didn't have time for that. My business was survival, anything that got in the way had to be gotten over/around/under or moved.
So there you have some of the reasons patients don't participate in clinical trials. I did participate in a post chemo study of simvastatin in the prevention of recurrance of breast cancer in high risk women. That was a great experience and it came at the perfect time.
- Posted by Dale Ashera-Davis 6/12/09 5:32 AM
Three major reasons for lack of participation in clinical trials: Cost, Location and Placebo.
1) Costs to the patient are exhorbitant.
A) In my case, one facility wants over 6500 up front to cover copays, deductibles and coinsurance.
B) The drug companies will not cover costs of scans and other diagnostic tests, usually stating that these are 'usual and customary standard of care' that the patient would have received otherwise. However, what they fail to realize is that most patients would not be getting nearly the amount of tests if they were not in a clinical trial. For example, some trials run diagnostics every two or three months, but if you were not in a trial, you may only have scans every 6-12 months. These multiple scans really run up a patient's medical costs.
2) Many trials are not conveniently located. Again, this relates to costs. Some drug companies cover travel, but others don't. Many patients cannot afford to travel (even reimbursed travel can take 6 months or more to be refunded to the patient). Many patients cannot drive a long distance. I myself, am to fatigued to drive more than a couple hours.
3) After having to pay thousands of dollars up front, I may still receive a placebo. I understand the scientific rationale behind use of placebo, however, what a waste of my time and money. Meanwhile, my cancer continues to spread. Additionally, in some trials, if the patient shows progression and is found to be on the placebo, the drug company refuses to offer the open-label drug.
If the drug companies really are looking for a way to increase trial participation, they should consider 1) increasing the number of locations and 2) covering more of the costs.
- Posted by Alicia Bailey 6/13/09 12:39 AM
I was recently given the opportunity to participate in a Phase II clinical trial. I decided to go ahead with it because I had already received several different chemo drugs over the past 2-1/2 years and felt this might be the one that did the trick. After going over the eligibility questions, I was asked to go for a CT scan and EKG, which I did. On the day I appeared for what was supposed to be the beginning of the treatment, I was advised that my prior treatment precluded my participation. I was quite upset at not having this covered earlier.
- Posted by Carole Carpenter 6/13/09 5:04 PM
The Dr. Susan Love Research Foundation would like to thank you for blogging about the Love/Avon Army of Women (www.armyofwomen.org) We appreciate your mention and want to emphasize how you can be part of our mission of moving breast cancer beyond a cure and one step closer to prevention. We are encouraging women of all ethnicities and ages to join, so please go to www.armyofwomen.org and sign up today. We also have weekly blogs about the Army of Women, so feel free to visit our website, http://blog.armyofwomen.org. And don’t forget to follow us on Twitter @ armyofwomen!
- Posted by Dr. Susan Love Research Foundation 7/13/09 11:52 AM