Obstacles and Progress in Clinical Trials
Laura Cleveland is a 18 yr CLL patient, an impassioned patient advocate and a peer reviewer of late phase cancer clinical trials for the NCI Institutional Review Board (IRB), with focus on trial design, accrual issues, regulatory mandates and informed consent.
Cleveland has 12 years experience in designing, evaluating, and reviewing clinical trials, and I was interested to get her thoughts on the clinical trial process, obstacles that patients face and any recent progress being made in the clinical trial arena.
Obstacles to Clinical Trial Enrollment
It is no secret that clinical trials face accrual problems. Half of all phase III clinical trials close because of insufficient accrual with only 2% of cancer patients participating. In Cleveland’s opinion, some of the biggest obstacles are:
- The myth that clinical trials are purely experimental and that the subjects are treated as “guinea pigs”. Cleveland explained that, in trials, patients are followed much more closely than they would be in normal treatment situations and that all standards of care actually evolved from clinical trials.
- Logistics – Enrollment is often delayed due to eligibility criteria or rules and regulations concerning testing and screening.
- Randomization and the fear of receiving “placebos” instead of cancer medication. Cleveland explained that placebos are rarely given in cancer clinical trials. When drugs are compared, the experimental drug is compared to the Standard of Care, She went on to say that there is even a push to remove randomization from certain trials and that there are currently single arm clinical trials available.
- Cost – If insurance does not cover the costs of extra tests and doctor visits, it can be costly for the patient. There are organizations that help with these costs, but often the patient must bear the burden of significant cost outlay.
I asked Cleveland what the one thing is that industry/government can do to make the clinical trial process easier for patients. She had a very simple 3 word answer:
“Pay for it”
Progress Being Made in the Clinical Trial Process
When asked what progress had been made recently in the clinical trial process, including enrollment, navigation and process in general, Cleveland had several comments:
- The patient materials are becoming more understandable and easier to read. The documents are being “translated” into plain language, the informed consent form is getting shorter and less complicated. Cleveland has been working with the National Clinical Trials Network on this for the past several years.
- Patient-friendly clinical trial results are being published so that patients can read about these trials and understand them. Cleveland has been working with the Alliance for Cancer Clinical Trials on this.
- Cooperative Groups have been working on ways to change the consent process and clinical trial protocols. These groups get together and discuss strategy to improve the whole clinical trial process to make accrual more attractive and patient-friendly. This is a slow process but encouraging steps are being taken. Cleveland said that patients are given a clinical trial “packet” that often, they do not understand. She further explained, “There needs to be a patient-friendly summary that the patient can read and easily understand before they even attempt to read the Informed Consent form. This summary needs to be in plain language and outline the clinical trial that they are considering.” Apparently, this type of summary exists for a few clinical trials, but it needs to be the rule rather than the exception.
- Clinical Research and Clinical Trials need to be in the vernacular. They need to become everyday words and concepts. Social media is helping in this effort. Tweets and Facebook posts help with awareness. But there needs to be more effort in this direction. Possibly, clinical research staff could visit Middle School or High School and talk to the science or health classes about trials. Children can be great advocates of causes and could bring the word home to siblings and parents. Breast Cancer groups have done a great job for breast cancer awareness; they could really help by spreading the word about breast cancer clinical trials and clinical trials in general. Much, much more needs to be done in this area. Cleveland summarized,
“As far as getting the word out about clinical trials, it’s just not there.”
In closing, Cleveland had several words to say to patients about self-advocacy.
“Get a second opinion! Seek out a specialist in the specific disease area that you have. Find out who is doing research in that area and contact them. Use all resources available to you. You must be your own self-advocate.”