Randomised trials are challenging to conduct and even when well designed, post-randomisation events will occur during follow-up which affect the interpretation of results. For instance, patients may stop taking their allocated treatment and/or withdraw from the study, they may receive rescue medication, or they may die before the outcome can be measured. These issues can pose a challenge to the interpretation of the trial, and are often the source of debate around the validity of results.
In November 2019, ICH issued an addendum to ICH E9 (R1) (1) entitled Estimands and Sensitivity Analyses in clinical trials to address such issues. In this webinar we will summarise the detail in ICH E9 (R1) (1) and how it impacts clinical development plans.
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Alan Phillips, Ph.D., B.Sc., C.Stat.
Senior Director Biostatistics, Clinical Research Services, ICON plc.
Dr. Phillips is Senior Director Biostatistics providing consultancy services to the Pharmaceutical Industry. Prior to this role, he was Vice President Head of Biostatistics for ICON Clinical Research where he directed and managed the global biostatistics resources based in US, Europe and Asia Pac. With over 35 years of experience in biostatistics, Dr. Phillips has extensive knowledge of clinical trials, statistical methodology and world wide statistical regulatory requirements. Prior to joining ICON, Dr. Phillips was with Wyeth Research for over 12 years and served as Senior Director, Clinical Biostatistics. Subsequently Dr Phillips has both CRO and Pharma experience.
Dr Phillips has experience of regulatory submissions in Biosimilars (Rituximab, Herception), CNS (depression, insomnia, Generalized Anxiety Disorder), Cardiovascular (Hypertension), Oncology (Breast Cancer) and Women’s Health (Hormone Replacement Therapy, Oral Contraceptives). For example, Dr. Phillips was recently involved in developing and justifying the sample size and statistical strategy for managing missing data for a biosimilar development program with the FDA. Dr. Phillips has also represented sponsors at US and EU scientific advisory and approval meetings.
Dr. Phillips received his B.Sc. degree in mathematics from the University of Exeter and his Ph.D. in statistics from the University of Birmingham. He has published in a number of areas including adaptive trial designs, estimands and sensitivity analyses, patient recruitment modelling, regulatory statistical challenges (eg missing data, multiplicity), sample size estimation, and statistical principals for clinical trials. Dr. Phillips is affiliated with the Royal Statistical Society (RSS) and Statisticians in the Pharmaceutical Industry (PSI). In 2012, Dr Phillips was made an Honorary member of PSI in recognition of his scientific contributions to the organisation. Dr Phillips is also an Adjunct Associate Professor at University College Dublin and visiting Senior Lecturer at King’s College.
Tim Clark, Dip. Stat., PhD
Vice-President, Clinical Sciences, Drug Development Services, ICON plc.
Dr Tim Clark gained his PhD in clinical trial methodology at the Institute for Medical Informatics, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University, Munich. Tim is part of the Drug Development Services group, which provides strategic drug development advice to customers and internal teams. Tim specialises in clinical study design and protocol optimisation.
Prior to joining ICON in 2009, Tim worked in clinical research and regulatory affairs for large French and American pharmaceutical companies and as an independent consultant advising on a range of drug development issues. He has worked on small molecule and biological (including biosimilars) programmes indicated for cancer as well as CNS, autoimmune, cardiovascular and infectious diseases.
Tim has published on clinical study design, protocol optimisation and sample size determination in peer reviewed journals and is currently an Honorary Associate Professor at the Institute of Clinical Trials & Methodology, University College London.
Dr. Alastair Mackinnon
CMO and Co-founder, Mereo BioPharma.
Alastair is the Chief Medical Officer and a co-founder of Mereo. Prior to Mereo, he was a Partner at for Phase4 Partners, a global life science venture capital firm. He was also involved in Phase4’s MBO in 2010 having originally joined Nomura in 2005.
Before Nomura, he was a practising physician in the UK for 10 years. Alastair received a BSc and MBBS from King’s College London, is a Member of the Royal College of Surgeons of Edinburgh (MRCS) and has a Diploma in Corporate Finance from the London Business School. Alastair is a board member of Phase4 Partners.
Addendum on estimands and sensitivity analyses in clinical trials to the guideline on statistical principles for clinical trials, ICH E9 (R1). Available at https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf