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PROF. ALISTAIR NICHOL

Alistair is a senior intensivist and clinical trialist. The ‘nerd’ has always been strong with Alistair and he developed a research interest early in his clinical career. He completed a PhD examining a model of infectious ARDS and the effects of hypercapnia on inflammation and damage. This work has led to his ongoing interest in mechanical ventilation and ARDS. He was working in Australia during the H1N1 pandemic and was part of a team which described the pandemic in Australia and published in the NEJM, however, despite their best efforts were unable to conduct a trial during the first wave. In an effort to improve our clinical trial response to a future pandemic he has been part of an EU FP7 program (PREPARE) which has been preparing for a global pandemic since 2015. As part of this effort the REMAP-CAP trial, a global adaptive platform trial, has determined that steroids, anticoagulation (in moderate disease) and IL-6 RA are beneficial in COVID-19 and many other therapies are not helpful hydroxychloroquine, lopinavir / ritinovir, convalescent plasma and anticoagulation in critically ill patients. Irish hospitals, investigators and patients have contributed to these findings and are randomising to many additional interventions. He is also part of the SPRINT-SARI observational study which has described the impact of COVID-19 in Ireland and globally. In addition, to pandemic preparedness, he has an interest in trauma, brain injury and mechanical ventilation.

Alistair is the Chair and Professor of Critical Care Medicine in University College Dublin (UCD), the immediate previous Chair of the Irish Critical Care-Clinical Trials Group (ICC-CTG), Director of the HRB Irish Critical Care- Clinical Trials Network (HRB ICC-CTN). He has a long commute as he also works in the Australian and New Zealand Intensive Care-Research Centre (ANZIC- RC), Monash University, Melbourne. He also has 4 kids aged between 5 and 11 and therefore has no hobbies or interests but lives in hope of that changing.

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02novWEBINAR - Why ITT analysis is not always the answer for estimating treatment effects in clinical trials - Dr Alan PhillipsEvent-Type:Webinars

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Dr Alan Phillips, Senior Director, Biostatistics, ICON Clinical Research.

Tuesday 2nd November at 2.00pm (GMT)

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For many years there has been a consensus among the Clinical Research community that ITT analysis represents the correct approach for the vast majority of trials. Recent worldwide regulatory guidance for pharmaceutical industry trials has allowed discussion of alternatives to the ITT approach to analysis; different treatment effects can be considered which may be more clinically meaningful and more relevant to patients and prescribers.

The key concept is of a trial “estimand”, a precise description of the estimated treatment effect. The strategy chosen to account for patients who discontinue treatment or take alternative medications which are not part of the randomised treatment regimen are important determinants of this treatment effect. One strategy to account for these events is treatment policy, which corresponds to an ITT approach. Alternative equally valid strategies address what the treatment effect is if the patient actually takes the treatment or does not use specific alternative medication. There is no single right answer to which strategy is most appropriate, the solution depends on the key clinical question of interest.

The estimands framework discussed in the new guidance has been particularly useful in the context of the current COVID-19 pandemic and has clarified what choices are available to account for the impact of COVID-19 on clinical trials. Specifically, an ITT approach addresses a treatment effect that may not be generalisable beyond the current pandemic.

Dr. Alan 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). Dr. Phillips frequently represents 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, 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.