Tutorial- Tuesday at 3:00 PM EDT
Title: Statistical Considerations in Decentralized Trials
Presenters: Melanie Poulin-Costello, Roche

Abstract:
One of the many benefits to patients of the decentralized trial is improved recruitment in the rare disease space. The ALpha-T trial (NCT04644315) is a Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic Anaplastic Lymphona Kinase (ALK)-Positive Solid Tumors. Alectinib is approved for ALK positive Non-small cell lung cancer (NSCLC). ALK positive cancers excluding NSCLC occur in approximately <1% of all other cancers. The home based approach of ALpha-T improves recruitment in a rare disease setting as well as providing patients the familiarity of their home clinic and oncologist. However, with confirmed objective response rate (ORR) as the primary outcome, variability both within and among patient tumour assessments will be of statistical interest in the outcome of decentralized trials. Other sources of variability such as safety assessments, patient care will also be observed in ALpha-T. Additionally as a decentralized trial may also increase diversity, baseline demographics may also be of interest. As decentralized trials increase, statisticians will play an essential role to shifting the paradigm of how we conduct clinical trials.

Bio:
Melanie Poulin-Costello is Director of Biostatistics in product development at Hoffman La-Roche. Melanie started her career in the pharmaceutical industry as a clinical trial statistician at Bayer. She became project lead statistician for Nexavar©, the first treatment for renal cell carcinoma. Melanie then worked at Amgen where she covered many therapeutic areas including oncology, rheumatoid arthritis, nephritis. She worked on clinical trials as well as Health Technology Assessment and Real World Evidence. At Roche since 2016, she oversees oncology drug development in the tumour agnostic and rare disease space. Melanie is also involved in novel approaches to drug development, specifically the TransCelerate Historical Trial Data data sharing initiative. Melanie is an adjunct professor in Biostatistics at University of Toronto’s Dalla Lana School of Public Health. Melanie has her undergrad BMath from the University of Waterloo and an MSc in statistics from University of Victoria.
Melanie has lives in Canada with her husband and has 3 adult children. In her spare time Melanie loves to paint and draw. She loves hiking and canoeing and recently obtained her PADI certification for scuba diving.