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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
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:
Vendor show vendors registered to date:
Registration deadline:2019-10-18  (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

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2019-12-10, In Vitro Diagnostics (IVD), Companion Diagnostics (CDx) and Precision Medicine
2020-01-10, All about half-life: which one should I use? (tentative title)
2020-02-11, Development of Drug/Device Combinations
2020-02-24, MS Courses by Dr. Jack Henion: Advanced LC-MS/MS (Day1) & Interpretation of MS/MS CID Spectra (Day2)
2020-03-16, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
2020-04-10, Biopolymer-based conjugation of therapeutic proteins and antibodies for improving drug properties (tentative title)
2020-05-12, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-05-22, No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-06-23, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
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