Laurence Collette
Principal Statistician, Consulting Services
International Drug Development Institute (IDDI).
Clinical trials – Introduction to clinical trials and evidence levels for establishing the use new treatments and technologies.
Abstract:
During this talk, attendees will learn about the process of clinical development of new therapies from early phases of development to assess a treatment’s safety until establishing the treatment for use in clinical practice. After a rapid review the traditional phased development and associated study designs, we will discuss more recent developments of clinical trials designs that address the challenges of modern treatments such as immunotherapies and personalized anti-cancer medicines. We will also review the current regulatory requirements and future trends in relation to drug approval and the need for randomized trials.
Key references:
FDA Guidance for industry. ICHE9: statistical principles for clinical trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9-statistical-principles-clinical-trials.
FDA guidance for industry Adaptive Designs for Medical Device Clinical Studies. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-designs-medical-device-clinical-studies
Eichler HG, Pignatti F, Schwarzer-Daum B et al. Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. Clin Pharmacol Ther. 2021 May;109(5):1212-1218.
Biography:
Laurence Collette, MSc, PhD: Principal Statistician, Consulting Services at the International Drug Development Institute (IDDI). She graduated in Mathematics at the Université Catholique de Louvain, Louvain-la-Neuve, and in Biostatistics at the Hasselt University, in Belgium, and did her PhD at the Erasmus University in Rotterdam, The Netherlands. After 25 years developing cancer treatments mostly through phase II-IV academic clinical trials with the European Organisation for Research and Treatment of Cancer (EORTC), she joined IDDI to develop and apply her expertise to earlier development phases of new drugs. She has a special interest in large pragmatic clinical trials, and in adaptive designs, when they bring efficiency gains that outperform their extra complexity. She is also member of several IDMC and of research programs such as IMI-PIONEER (big data in prostate cancer) and the IGCCCG update consortium (prognostic factors for testicular cancer).