Health Decisions is a contract research organization (CRO) honed in on women’s health clinical research, and diagnostic and device development; OncoBayClinical tackles complex, early-phase oncology programs. Together, the two CROs will harness expertise in women’s health and oncology to bolster clinical programs for sponsors seeking novel treatment options in women’s cancers.
Patrick Phillips, Health Decisions CEO, told Outsourcing-Pharma that women historically are underrepresented in clinical research, even in trials investigating treatments specifically for women.
“In one study of the interaction between alcohol and flibanserin – a treatment for female hypoactive sexual desire disorder – 23 of the 25 study participants were male,” he pointed out. “Another 2018 analysis published in the Journal of the American College of Cardiology (JACC) found that in trials supporting 36 cardiovascular approvals, just 34% of trial participants were female, despite the fact that cardiovascular disease is the leading cause of death among women.”
He also told us that because clinical research is largely male dominated, there is a distinct lack of data on long-term impact of medicines on women, putting women at risk and making manufacturers vulnerable to the consequences of unexpected outcomes. Women and men also perceive clinical research differently.
“A 2017 survey found more men believe clinical trial participation should be a routine part of health care than women. At Health Decisions, we are examining what drives female participation in studies, what aspects of studies may be deemed burdensome, and then creating strategies that ensure patient engagement while addressing sponsor, clinical site, and regulatory requirements,” he said.
Krystyna Kowalczyk, OncoBay Clinical president and CEO, commented that the collaboration brings together two organizations committed to advancing oncology treatments.
“Together, we look forward to delivering significant value to drug developers and physicians in their quest to cure women’s cancer,” she said.
Phillips commented that the collaboration opens up possibilities for sponsors looking for support in developing treatments for women’s oncology.
“Our combined understanding of female-centric clinical trials and the complexities of studies in oncology will enable strategic and flexible end-to-end solutions for our sponsor partners,” Phillips said. “We believe the technical insight and operational agility created by combining our teams will allow us to accelerate clinical development activities, further supporting our mutual mission of improving the lives of patients around the world.”
Because in most cases the first signs of women’s cancers are detected during routine gynecologist visits, the partnership between Health Decisions and OncoBay will use a combined site network specialized in women’s health and oncology to help accelerate identification of potential participants. Additionally, the project will draw upon OncoBay’s partnership with TrialJectory, a company that uses artificial intelligence (AI) to curate research data and match patients to trials.
“With hundreds of thousands of women being diagnosed with cancer each year, it has become increasingly important to engage these patients where they are located and ensure access to the most advanced treatments for their exact diagnosis,” said Tzvia Bader, TrialJectory CEO and cofounder. “Through the team's vast expertise in women’s oncology needs, both OncoBay and Health Decisions, coupled with TrialJectory’s AI-powered digital health platform, are providing the next generation of cancer care to countless women in need.”
