Note: Last year, TESARO, a pharmaceutical company developing a new PARP inhibitor for treatment of ovarian cancer and metastatic breast cancer, asked FORCE to help recruit previous clinical trial participants to join focus groups across the U.S. TESARO wanted to understand the patient experience to build clinical trials that are more responsive to patient needs. We asked TESARO to share what they learned with us so that we can pass their findings back to the community. This article is part of our blog series on clinical trials and research.
by Beth Zaharoff
TESARO, an oncology-focused biopharmaceutical company based in MA, conducted a series of focus groups for women with breast or ovarian cancer who had participated in a non-TESARO-sponsored clinical trial. The goal was to identify issues experienced by patients when participating in oncology clinical trials. TESARO is using the insights we gained to design improved trials that not only address important scientific questions, but also respect and appreciate the issues that are most critical to those who participate.
Focus group participants were identified through cancer advocacy and support organizations, including FORCE. Twenty-one women participated in four focus groups in New York, Ann Arbor, Kansas City and Santa Monica—their ages ranged from 35 to 73 years; average age was 57.2 years. Seven women had been diagnosed with ovarian cancer, and 14 with breast cancer.
Many of the findings were consistent with those reported in published literature. Women previously enrolled in breast and ovarian cancer trials were motivated to participate in oncology clinical trials for altruistic reasons, but also for the hope of finding a better cure. Despite generally positive experiences from their participation, some of the key findings from our focus groups were:
- Concerns about the complexity of the informed consent form.
- little or no expression of appreciation for participants from the clinical trial staff.
- limited communication about the ongoing status of the trial or results once completed.
- limitations of most patients to absorb all the information that needed to be communicated about the clinical trial, its benefits, and its risks.
As a result of what we learned, TESARO is implementing a number of initiatives to increase satisfaction for those who volunteer to participate in the trials that we sponsor, including the following:
- At their first and last study visits, participants will receive a folder of information, including a letter thanking them for their participation.
- The introduction folder will also include brochures from relevant advocacy organizations (including FORCE), a single-page, simple description of the clinical trial, and a simple list of what to expect at each study visit (procedures and time commitment).
- A section on clinical trial FAQs has been added to our clinical trial webpages.
- We will include a section on these focus groups, and stress the importance of making the study patient a priority at each pre-study start-up investigator meeting.
- We are writing study participant newsletters to keep participants updated.
- We will launch a process whereby patients/advocacy representatives will give input as we are developing new projects, etc.
- We will share our progress on these new initiatives with advocacy groups and health care providers who can disseminate the information to the patient community.
To all the patients who participated in our focus group, and everyone who has ever enrolled in a clinical trial or will enroll in the future, a deep and heartfelt “thank you.” Your involvement is crucial to advancing medical care and improving patient outcomes.
Beth Zaharoff joined the Clinical Operations Department at TESARO in January, 2014. Before that, she worked as the Associate Director, Medical Affairs for Spectrum Pharmaceuticals and as a Medical Science Liaison for MedImmune, MGI Pharma and Allos. She spent 4 years as the Manager, Oncology Operations and Clinical Trials at New England Medical Center. It was during that time that a close friend was diagnosed with acute myeloid leukemia, and Beth decided to spend the rest of her career (and then some) working in cancer research. Beth worked as the Institutional Review Board Administrator at Boston City Hospital where she found her passion for clinical research.
Tags: BRCA 1, BRCA 2, brca research, BRCA1, breast cancer, clinical trials, metastatic breast cancer, ovarian cancer treatment