On September 23, 2021 Global Coalition for Adaptive Research (GCAR) reported a new clinical trial initiative, Ovarian CanceRx (Press release, Global Coalition for Adaptive Research, SEP 23, 2021, View Source [SID1234590253]). This innovative trial, referred to as an adaptive platform trial, is designed to test multiple drugs simultaneously against the standard of care treatments to rapidly test and deliver new therapies to patients with advanced ovarian cancer or recurrent platinum-resistant disease.
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The Ovarian CanceRx platform trial is designed to be more efficient and reduce the development time of testing new investigational drugs, while providing a more patient-centric approach that increases access to new potentially life-changing therapeutic options for women with ovarian cancer.
"As a clinician and researcher driven to bring better treatment options to my patients, efforts like Ovarian CanceRx are essential to rapidly advance new treatments that can improve patient survival," said Beth Karlan, Chair of the Ovarian CanceRx Steering Committee. "Working in collaboration with key members of the research, clinical and patient advocacy communities, Ovarian CanceRx capitalizes on novel drug development to give ovarian cancer patients access to potentially beneficial treatments at a time when they need them most – now!"
Ovarian cancer is less common than breast cancer, although it is more deadly. There are nearly 300,000 new cases diagnosed each year worldwide making ovarian cancer the fifth leading cause of cancer-related deaths in women. While there are numerous randomized control trials in ovarian cancer, there are still significant unmet clinical needs in this field. Patients with ovarian cancer have not benefited from new therapeutics the same way other cancer patients have for a number of reasons including a lack of innovative clinical research approaches that can rapidly adapt and evaluate new therapies as they become available. Additionally, there are challenges to recruiting enough patients to participate in trials given that ovarian cancer is a relatively uncommon disease. While the traditional randomized control trial remains the gold standard, it can often be inefficient and very expensive and may not be equipped to accommodate the complexities of the diverse ovarian cancer subtypes.
To address these hurdles, Professor Andrew W. Lo from the Laboratory for Financial Engineering at Massachusetts Institute of Technology (MIT) organized a series of meetings to bring together a committed group of scientists, clinicians, patient advocates, investors, philanthropists, and industry representatives to discuss opportunities in therapeutics and diagnostics and improved financial models for ovarian cancer focusing on innovations in clinical research. With a generous $1 million donation, GCAR, a non-profit organization with extensive experience in developing and executing master protocol and platform trials, has taken the reins to develop Ovarian CanceRx as an efficient, cost-effective and advanced model for drug development and improved patient outcomes.
"Given the challenges of the traditional trials, platform trials, provide a unique opportunity to accelerate advancements in ovarian cancer research," shared Meredith Buxton, CEO, GCAR. "Ovarian CanceRx will help to identify science-driven treatment options for women with advanced ovarian cancer or recurrent platinum-resistant disease. GCAR is excited to provide seed funding, support the work of foremost experts in ovarian cancer clinical care and research, and sponsor this important effort. Ovarian CanceRx represents innovation, efficiency and a patient-centric approach to clinical research."
A key stakeholder in the effort is Ovarian Cancer Research Alliance (OCRA), the world’s largest ovarian cancer charity. OCRA provides funding for research, advocates on Capitol Hill, and supports patients and their families. OCRA has served as an essential partner, providing the voice of the patient, since Ovarian CanceRx efforts initiated.
"We are delighted to partner with GCAR, the gynecologic oncology clinical and research community, and patients on this important effort to identify better treatment options for those with ovarian cancer," stated Audra Moran, President and CEO, Ovarian Cancer Research Alliance. "Collaborating on Ovarian CanceRx fits squarely into one of the cornerstones of our mission to support the most promising scientific research, seek out better treatments, and hasten desperately needed breakthroughs."
The Clearity Foundation, a non-profit science-based advocacy organization for women and families impacted by ovarian cancer, recently joined Ovarian CanceRx to provide clinical trial resources and patient education as well as treatment decision and psychosocial support.
"We believe that all women deserve the best possible therapies for their unique disease as well as personalized emotional support for their particular life challenges," said Hillary Theakston, Executive Director Clearity. "Through GCAR’s Ovarian CanceRx partnership we are gratified to support an innovative clinical trial design that will improve treatment for women with ovarian cancer."