Online Registry Improves Clinical Research Study Participation
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Los Angeles - July 13, 2015 – Research for Her™, Cedars-Sinai’s groundbreaking online registry that matches women with research studies and clinical trials, enrolled study participants more quickly when compared with traditional paper-based registries, according to new research published in the journal Gynecologic Oncology.
Historically, fewer women have participated in clinical research and only 3 to 5 percent of patients nationally enroll in trials.
"Research for Her is committed to changing these statistics and improving patient lives," said B.J. Rimel, MD, co-principal investigator of Research for Her, part of the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, and first author of the study.
A total of 322 women were enrolled in the Cedars-Sinai Research for Her registry over a 14-month period – a 4.3 fold increase over the paper-based registry. Of these 322 women, 263 were matched to at least one study and of those, 39 eligible individuals went on to enroll. The enrollment process increased in speed by 27 percent.
The Research for Her registry also spurred a 50 percent increase in enrollments for the Gilda Radner Hereditary Cancer Program, part of the Women's Cancer Program at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, in 2014. Founded in 1991, the Gilda Radner program consists of several research studies for women at higher risk for breast and ovarian cancer.
Research for Her, created in 2013, is currently open to all women over the age of 18 with or without a prior history of cancer. It soon will expand to also enroll and link men to available clinical trials or research studies at Cedars-Sinai.
"The early successes of Research for Her are encouraging," said Steven Piantadosi, MD, PhD, director of the Samuel Oschin Comprehensive Cancer Institute and the Phase One Foundation Chair. "We are eager to continue fostering the program’s growth and potential, while bolstering patient lives."
Next steps also include identifying innovative methods to capture complex data from patients – such as molecular tumor profiling – to further decrease the time to enrollment for studies and provide more comprehensive prescreening for patients.
Additional Cedars-Sinai authors involved in the study include Research for Her co-principal investigator Beth Y. Karlan, MD, director of the Women's Cancer Program at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology; Jenny Lester, MPH, CCRP, senior research project advisor in the Women’s Cancer Program at the Samuel Oschin Comprehensive Cancer Institute; Catherine Bresee, MS, senior biostatistician in the Cedars-Sinai Biostatistics and Bioinformatics Core; Diane Park, clinical research coordinator; and Catherine Dang, MD, associate director of the Wasserman Breast Cancer Risk Reduction Program. Leah Sabacan, MBA, now with the University of California, San Francisco, also contributed to this study.
Citation: Gynecologic Oncology: 2015 July: A novel clinical trial recruitment strategy for women's cancer.