On June 17, 2021 The Children’s Oncology Group (COG), the world’s largest organization devoted exclusively to childhood and adolescent cancer research, and Signify Health, Inc. (NYSE:SGFY), a leading platform that leverages advanced analytics, technology and nationwide healthcare provider networks, reported a partnership to facilitate clinical trial participation for pediatric patients through in-home clinical services (Press release, Children’s Oncology Group, JUN 17, 2021, View Source [SID1234584158]).
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Through this new collaboration, pediatric patients participating in COG Study AALL1731, a clinical trial for a therapy to treat B-cell acute lymphoblastic leukemia (B-ALL), now have expanded options to facilitate receipt of experimental treatment at home. Participating in clinical trials that involve infusion therapies can be challenging for families because infusions require a credentialed provider to administer them, and because home health agencies are unable to bill insurance for investigational therapies.
AALL1731 (NCT03914625) is sponsored by the National Cancer Institute under a Cooperative Research and Development Agreement (CRADA) with Amgen, and is currently open at 195 U.S. COG sites. This in-home infusion service is for the patients assigned to receive blinatumomab on AALL1731 who are unable to access outpatient pumps and homecare. Amgen has provided funding to NCI under the CRADA to support more pediatric patients to receive blinatumomab at home.
B-ALL is the most prevalent childhood cancer, representing 20% of diagnoses in children younger than 15 years old and is the leading disease-related cause of death for children ages one to 19. Although improved treatments have led to higher survival rates for children with B-ALL, approximately 15% of children will have their leukemia return after remission is achieved. More effective treatment is needed for these children. Promising new therapies have the potential to alter the course of disease progression and removing barriers to participating in clinical trial programs is a primary focus for researchers and drug sponsors.
"This collaboration to provide in-home clinical services will allow more children to spend time at home receiving the investigational therapy while enabling much-needed research to deliver safer, and hopefully more effective therapies," said Mignon Loh, M.D., Chair of the COG ALL Committee. "A decentralized clinical trial approach will relieve unnecessary stress on families who are struggling financially and emotionally from their child’s cancer diagnosis. We hope that home access to investigational agents will increase participation in these important clinical trials."
Signify Health’s home-based clinical support services can help patients initiate investigational and approved therapies faster, improve their adherence, and provide a better overall experience for patients and families. Signify Health’s national network of credentialed clinicians will provide in-home infusion pumps and infusion bag changes to pediatric patients who have requested the in-home alternative. Signify clinicians will document patient metrics in real-time and be on call for the first 24 hours after a bag change to address any potential pump malfunctions.
"There is no better use of our network than to help children with cancer access potentially life-changing therapies," said Kyle Armbrester, CEO of Signify Health. "By activating the home as an alternate site of care, we hope to alleviate some of the burden and stress for families so that they can spend more time and energy focusing on what matters most."