Green Park Collaborative and Allergy & Asthma Network Publish a Core Outcome Set for Clinical Trials in Moderate to Severe Asthma
Apr 6, 2021
BALTIMORE, April 6, 2021 /PRNewswire/ -- The Green Park Collaborative (GPC), a major initiative of the Center for Medical Technology Policy (CMTP), in partnership with Allergy & Asthma Network (AAN), led a stakeholder consensus initiative to recommend outcomes that should be core across all phase 3 and 4 clinical drug trials for moderate to severe asthma.
The report, published in the Annals of Allergy, Asthma and Immunology, describes the multi-stakeholder consensus process used to prioritize nearly 100 outcomes down to a final set of five core outcomes. Participants represented many perspectives, including patients, clinicians, researchers, payers, health technology assessors, regulators, and drug development companies.
"The coreASTHMA core outcome set is a triumph. Even in a condition like asthma, where the most important outcomes for clinical research might seem self-evident, valuable insights on outcome selection were gained through multistakeholder engagement. I am confident that as these insights are adopted into clinical research, producing more relevant data consistently, patients will be the ultimate winners," says Donna Messner, President & CEO, CMTP.
With many recently approved and additional emerging therapies in asthma, outcomes used in trials are heterogenous — creating challenges for drawing meaningful comparisons between these therapies. "Consistent inclusion of these outcomes will allow comparison across trials to provide further guidance on benefits of one therapeutic option versus another," says Vickram Tejwani, Pulmonary and Critical Care Fellow, Johns Hopkins Hospital.
Furthering their partnership, CMTP and AAN have also launched a follow-up initiative called coreASTHMA QoL to build upon the insight gained from coreASTHMA that current asthma-specific quality of life measures do not readily translate into meaningful improvements in patients' lives. "The coreASTHMA project highlighted that asthma-specific quality of life is an important outcome to patients. In coreASTHMA QoL, we will ensure this outcome is measured in a way that is relevant to how patients perceive quality of life," says Tonya Winders, President & CEO, AAN.
About the Green Park Collaborative (GPC)
GPC is a major initiative of CMTP, an independent 501(c)(3) non-profit organization dedicated to improving the quality, relevance, and efficiency of clinical research. GPC is a multi-stakeholder forum for developing condition-and technology-specific study design recommendations to guide the creation of evidence needed to inform both clinical and payment decisions.
About Allergy & Asthma Network (AAN)
AAN is the leading nonprofit patient education and advocacy organization for people with asthma, allergies, and related conditions. AAN's patient-centered network unites individuals, families, healthcare professionals, industry, and government decision makers to improve health and quality of life for Americans with asthma and allergies. We specialize in making accurate medical information relevant and understandable to all while promoting evidence-based standards of care.
Contact
Green Park Collaborative
Aisha Robinson
410-547-2687 ext. 114
[email protected]
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