GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
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Introduction to Adaptive Design for Clinical Trials

Start Date : November 15, 2018
End Date : November 16, 2018
Time : 9:00 am to6:00 pm

Phone : 18004479407
Email : globalcompliancepanel@gmail.com

Location :
DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

Website

Description

 


Course "Introduction to Adaptive Design for Clinical Trials" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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.


Randomized clinical trials remain the standard for clinical research. However, the cost of a traditional randomized controlled trial especially in large sample sizes and long study duration, are limiting factors of innovation in the pharmaceutical and medical device arenas. A trial with an adaptive design can often result in lower costs and more efficiency by making use of interim analyses with data accumulated during the course of a trial to modify a study, without compromising validity and integrity. Adaptive designs also allow for checking trial assumptions and progress before the conclusion of the study. Studies can be adapted for dose response, patient accrual, and early stopping for futility or patient safety concerns.


However, there are special considerations in the planning and execution of a adaptive design to control Type I error rates and ensure consistency of treatment. In additional to protocol considerations, the FDA and regulatory agencies also require particular assurances that an adaptive design will incorporate flexibility at the expense of sacrificing study validity and patient safety.


The objective of the seminar is to provide information that can be used immediately by personnel involved in the design and analysis of clinical trials. The presentation involves use of statistical techniques and a basic understanding of statistical theory and the framework of randomized controlled trials is desired. However, presentation of statistical theory and application will be limited to only what is needed by the attendees to understand and implement adaptive trial design and analysis.


R statistical software will be used to demonstrate analyses and simulation studies within the adaptive design framework. So bring your laptop computer!




Why should you 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:



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.


Therefore a number of considerations must be made in the design of an adaptive trial to enhance flexibility while minimizing bias, and ensuring statistically valid and well-informed decisions. Problems can arise in an adaptive design due to selection bias, interim analysis "look-sies", and when merging dose selection and confirmation phases into one trial.


The benefits of a clinical trial with an adaptive design include savings in both time and dollars, to the desired end of bringing useful drug treatments and devices to patients more quickly.




Areas Covered in the Session:





Who will benefit:



 


Agenda:


Day 1 Schedule




Lecture 1 (90 Mins): 
Introduction





Lecture 2 (90 Mins): 
Group Sequential Design





Lecture 3 (90 Mins): 
Statistical Methods for Group Sequential Designs





Lecture 4 (90 Mins): 
Sample Size Re-Estimation (SSR)



 


Day 2 Schedule




Lecture 1 (90 Mins): 
Phase II/III Adaptive Seamless Designs: Overview and Applications





Lecture 2 (90 Mins): 
Phase II/III Adaptive Seamless Designs: Statistical Methods





Lecture 3 (90 Mins): 
Practical Procedural and Regulatory Issues of Adaptive Design





Lecture 4 (90 Mins): 
Case Study and Protocol Examples, Q&A/Discussion



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.


 


Location:  Philadelphia, PA Date: November 15th & 16th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153


Price:


Until October 10, Early Bird Price: $1,295.00  Price: $1,295.00 (Seminar Fee for One Delegate)


From October 11 to November 13, Regular Price: $1,495.00


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%)*


 Register now and save $200. (Early Bird)


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=901894SEMINAR?seo


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901894SEMINAR?meetings4docs-nov-seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC - DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA., 161 Mission Falls Lane, Suite 216.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
Tel: 18004479407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901894SEMINAR?meetings4docs-nov-seo


Event Categories: Business Practice and Health & Nutrition.




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