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The World’s Leading Authority for Chronic Lymphocytic Leukemia Patients

The Role of Patient Advocates in Clinical Trial Design for CLL

In science and medicine, information is constantly changing and may become out-of-date as new data emerge. All articles and interviews are informational only, should never be considered medical advice, and should never be acted on without review with your health care team.

Laura Cleveland has had chronic lymphocytic leukemia (CLL) for 18 years, diagnosed when she was pregnant. She has been involved in advocating on behalf of her fellow CLL patients for more than 11 years.

Key Take Aways:

  • Patient advocates need to be involved in clinical trial design from the very beginning.
  • Low accrual is a huge problem, but recognizing what clinical trial designs best serve the patients can help to improve accrual rates.
  • Consent forms for clinical trials need to be easier to understand.
  • Clinical trials should be less expensive.
  • Fewer CT scans are now being done in CLL clinical trials.
  • Adaptive and fair clinical trial designs are being pushed by patient advocates
  • Changes come very slowly.

If we don’t make clinical trial designs more patient-friendly, we will continue to deal with the reality that only about one in 50 adult cancer patients will enroll in clinical trials and racial and ethnic minorities, women, and the elderly are even less likely to participate. For the background on this often-quoted statistic from the National Cancer Institute, see this link.

We need to have equipoise in trials as forcefully argued by Dr. O’Brien in this ASCO Post.

An online survey of patients fielded by Dr. Jim Omel and Karl Schwartz showed that the recommendation of an oncologist is the primary reason for considering and participating in a clinical trial suggesting a need to increase awareness of study protocols among treating physicians. Patient issues and perceptions regarding randomization, study risk, eligibility, and tests and procedures also provide opportunities to improve enrollment in clinical trials, especially focusing on the rationale of the protocol as a treatment decision. We also need to look at inventive trial designs as Omel and Schwartz have proposed here.

Laura works hard on our behalf to ensure that patient voices are heard when trials are being designed and rolled out.

Here is my interview from late April 2015 with Laura Cleveland at the CLL Society and Leukemia and Lymphoma Society sponsored patient dinner held the night before the CRC (CLL Research Consortium) patient forum in San Diego, CA.

Brian Koffman 10/29/15