Randomized trials, which sit at the top of the evidence-based medicine pyramid, are the gold standard approach to establishing causal inference between treatment and outcomes. Both phase 3 trials and randomized phase 2 trials rely on properly conceived and implemented randomization methods, without which selection and accidental bias may preclude firm conclusions. Moreover, phase 1 trials are increasingly randomized in this era of precision medicine and multiple competing treatment schedules that may be developed. Depending on trial size and goals, simple randomization, stratified randomization with permuted blocks, and dynamic methods of treatment allocation, including minimization, can be used to ensure properly balanced treatment arms with respect to known and unknown prognostic factors. The need for blinding adds a further layer of complexity, and additional issues come into play for randomized trials requiring this feature.
In this webinar, we will discuss the rationale for the various randomization methods, with illustration from real clinical trials and some considerations about the performance characteristics of the different methods. Importantly, we will discuss logistic issues related to the implementation of the various randomization methods. Finally, we will propose and discuss best practices to ensure that this implementation is done in a way that is faithful to the chosen method of randomization and that guarantees the trial integrity from beginning to end, without which the scientific and regulatory aspects of the trial may be jeopardized.
Everardo Saad, MD, Medical Director, International Drug Development Institute (IDDI)
Dr. Saad has over 15 years of experience in Medical Oncology and clinical trial designs. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients.
Linda Danielson, MS, Chief Operating Officer, Executive VP, International Drug Development Institute (IDDI)
Ms. Danielson has been at IDDI since 2006 overseeing all of the operational teams at IDDI including randomization, data management, statistics and project management. She co-authored a chapter on randomization in adaptive designs in the book: “Practical Considerations for Adaptive Trial Design and Implementation”, edited by Weili He, José Pinheiro, Olga M. Kuznetsova, Springer, 2014. Ms Danielson is interested in clinical trial design, statistical methods for clinical trials, randomization methods and increasing efficiency in clinical trials through web-based systems. She holds a MS in biostatistics from the University of Wisconsin, Madison.
Who Should Attend?
Clinical trialists, statisticians, IRT specialists, drug supply specialists, physicians, and other professionals involved in the design, conduct and analysis of randomized clinical trials.
International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology.
IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston (MA), Raleigh (NC) and San Francisco (CA).