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Introduction to Adaptive Design for Clinical Trials


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Who should attend?

Principal Investigators Clinical Investigators Clinical Research Statisticians Clinical Research Coordinators

Details

Description:

This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs.

The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize bias, and assess efficacy of new treatments as relates to comparison to competing therapies.

Why you should attend:

Clinical trials are expensive, time consuming, and labor-intensive. And in the traditional sense, study designs are inflexible.

Adaptive study designs allow for flexibility during a clinical trial. Options can be built into a study to use data collected that has accumulated at interim time points to:

  • Adjust sample sizes in treatment arms or reduce patient recruitment.
  • Drop treatment arms entirely (treatment pruning)
  • Adjust randomization schema
  • Combine Phase II and Phase III (adaptive seamless design)
  • Early stopping of a study for futility or success.

The U.S. Food and Drug Administration (FDA) and other regulatory agencies require the minimization of bias in study design and analysis. In order to minimize bias, particular steps and safeguards, using regulatory guidance and sound statistical principles, must be put into place to assure validity of an clinical.

Areas Covered in the Session:

  • Overview of Applications for Adaptive Design in Clinical Trials
  • Statistical Techniques of Adaptive Design
  • Practical Considerations for implementation of an Adaptive Design
  • Regulatory Aspects of an Adaptive Design
  • When an Adaptive Design is, and is not, Appropriate
  • Examples of Clinical Trials that Incorporated Adaptive Design
  • Computer Code in R Statistical Software for Simulation Studies

Who Will Benefit:

  • Trial Sponsors
  • Principal Investigators
  • Clinical Investigators
  • Clinical Research Statisticians
  • Clinical Research Coordinators
  • Clinical Research Nurse Coordinators

Speaker:

Elaine Eisenbeisz

Owner and Principal Statistician, Omega Statistics 

Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Location:  Chicago, IL Date: September 6th & 7th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  Will Be Announced soon

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

 

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901891SEMINAR?seo

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Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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