Poster session: The Impact of Clinical Review on Progressive Disease (PD) Assessments in Breast Cancer Trials from the Perspective of Blinded Independent Review Committee (IRC)
Incorporation of blinded independent review committees (IRCs) is frequently applied in clinical trials for tumor response assessments to improve objectivity and reliability. The IRC review process is composed of radiology assessment and can be followed by an oncology review to provide an overall integrated response assessment. Frequently, the radiology review is executed with 2+1 paradigm where the assessment results of 2 initial radiologists are compared and adjudicated by a 3rd radiologist if discordant, based on pre-designed adjudication variable(s). Subsequently, a review can be performed by an oncologists/hematologists integrating clinical data such as, cytology/pathology/photography results, physical exam findings not radiographically assessed, as well as on-study procedures (surgery or radiation therapy) to determine the impact of clinical data on an overall subject assessment. It’s prudent to incorporate a clinical review into the overall tumor response assessments, especially in diseases such as breast cancer where measurements of superficial skin lesions are identified on photographs by the oncologist and incorporated into the assessment.
Progression free survival (PFS) is an important study endpoint that plays a significant role for drug efficacy interpretation and used for regulatory approval. The presenter will evaluate the impact of clinical review on PD assessments in breast cancer trials in this poster session.
Poster authors: Di Luo M.D., Matt Marini M.Ed., Michael O’Neal M.D., Beatriz Lega M.D., Steven Soignet M.D.
Director, Medical & Scientific Affairs at Clario
Dr. Luo has extensive experience in clinical trials, including many global Phase II and III trials. He is an in-house reader at Clario for clinical review for various indications and has successfully supported more than 20 regulatory inspections with his strong medical expertise and knowledge in oncology. Dr. Luo has earned various degrees, including his doctorate with focus on oncology, Certificate of National Standardized Training for Oncology Physician and his Chinese medical license. He has authored articles in journals including Psycho‐oncology, Journal of Clinical Nursing, and Chinese General Practice; and has presented at conferences including International Psychosocial Oncology Society (IPOS) and International Conference on Head and Neck Oncology (ICHNO). Dr. Luo is a member of professional organizations including the Chinese Psychosocial Oncology Society (CPOS), Chinese Society of Clinical Oncology (CSCO), American Society of Clinical Oncology (ASCO).