Data that counts
WCHRI’s data team ensures breast cancer trial meets stringent standards
A study is only as good as its data. Clinical trials in particular must meet stringent requirements for data collection and management.
Breast cancer researcher Dr. Judith Hugh wanted to make sure that her clinical trial would yield reliable, high-quality results and comply with regulatory requirements. She got off to the right start by enlisting the data management team at the Women and Children’s Health Research Institute to set up a sound database system for her study.
“The team came up with a secure, easy-to-use system that is tailored to our needs and will provide us with meaningful data while meeting all of Health Canada’s compliance regulations,” says Hugh, who is a professor in the department of laboratory medicine and pathology at the University of Alberta and the first recipient of the Lilian McCullough Research Chair. Her study is among the nearly 550 research projects that have used WCHRI’s data management services over the past 10 years.
In her study, Hugh is challenging the standard treatment that is used for the most common form of breast cancer—estrogen receptor positive, or ER+, cancer. Estrogen has been blamed as the culprit in ER+ cancer. Hugh thinks that the opposite may be true and if she’s right, then the treatment received by about half of all breast cancer patients will change dramatically.
“The standard practice is to treat all women with ER+ breast cancer with anti-estrogenic drugs,” says Hugh. “There are two types of ER+ breast cancers, and it is commonly thought that estrogen feeds both ER+ cancers. That’s why women are told not to take hormones after menopause. But we think that estrogen actually kills one type of ER+ cancer, the most common type. If this is case, then about half of all breast cancers can be treated with estrogen.”
Hugh is testing her hypothesis in the first clinical pilot study in Canada of post-menopausal women who have the type of ER+ cancer that she thinks can be controlled by estrogen therapy. Her goal is to improve current treatment and care for thousands of Alberta women. About 2,500 new cases of breast cancer are diagnosed every year in the province, she notes. Her research may also result in better preventative care for post-menopausal women, who face an eight-fold increased risk of getting breast cancer.
Having a reliable, rigorous system to collect and analyze her clinical trial data will produce the hard evidence that Hugh needs to test her hypothesis.
Hugh’s research has been facilitated by WCHRI through generous support of the Lois Hole Hospital for Women.