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Workshop

Considerations for Successful Clinical Development: Fundamentals and Best Practices for Clinical Trial Design, Biostatistics, and Data Management


Speakers: Masoud Makhtarani, Douglas A Milikien, Hajime Arnold
Organizers: Douglas A Milikien, Shichang Miao, Peter Staehr
Date: 2020-01-21
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Samsung BioLogics;(Major Sponsorship - afternoon session still open)
Vendor show vendors registered to date: (3)Catalent; Grifols; QPS, LLC
Registration: http://www.PBSS.org
Registration deadline:2020-01-19  (it will close sooner if the seating cap is reached)

About the Topic

This full-day workshop offers an overview of the important steps and considerations when planning clinical trials for pharmaceutical or biologic products in the domains of 1) Clinical Development, 2) Statistics, and 3) Data Management. Throughout this very practical course, attention will be paid to recent scientific developments in the field, new regulations, best practices, and common pitfalls. The use of case studies throughout will illustrate the proper implementation of key concepts and design choices. Upon course completion, participants will have a solid understanding of key steps in the strategic product development, study design, data collection, and data analysis processes of clinical trials.

This workshop is intended for researchers who are either interested in designing a clinical trial, or who want to be better informed about clinical trials in order to improve communication with and understanding of clinical research colleagues, contract research organizations, investigators, members of the scientific and life science business communities, patients and other stakeholders.

 

Topics To be covered:

Clinical Development Considerations in Clinical Trials

  • Drug development process from bench to bedside
  • Objectives of different phases of the clinical program; safety, efficacy, approval
  • Basics of clinical trials designs: objectives, endpoints, assessments, outcomes
  • Good clinical practice: safety reporting, the role of investigators and sponsors

Statistical Considerations in Clinical Trials

  • Design considerations: framing the comparisons and choice of control group
  • Sample Size estimation
  • Planning for interim analyses : sequential studies, adaptive studies, seamless designs
  • Analysis Types:  continuous, binary, time-to-event, counts
  • Special handling necessary: multiple comparisons, missing data, and pooling

 Data Management Considerations in Clinical Trials

  • Data sources and structures: clinical visits, questionnaires, labs, PK/PD/PG, biomarkers, CDISC
  • Database build, documentation, and data transfers
  • Discrepancy management, query management, and reconciliations
  • Planning for ongoing and active data review during the study
  • Paradigm shift in data management: GDPR, privacy protections, third party data


2020-06-23, [Postponed due to COVID-19] Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
2020-09-17, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-10-19, [New Date] Preclinical and Clinical Development of Cell-based Immunotherapies: Translational PKPD, Safety, Biomarker, CMC, Clinical Pharmacology & Clinical Trials
2021-07-29, Development of Inhalation Therapeutics (a joint symposium by AAPS-BADGE / PBSS / Genentech)
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