2-day In-person Seminar: Introduction to Adaptive Design for Clinical Trials
In-Person Event
Nov 15 - 16, 2018
Philadelphia, Pennsylvania, USASpeakers
OVERVIEW
2-day In-person Seminar: Introduction to Adaptive Design for Clinical Trials is organized by GlobalCompliancePanel and will be held from Nov 15 - 16, 2018 at DoubleTree by Hilton Hotel Philadelphia Airport, Philadelphia, Pennsylvania, United States of America. This CME Conference has been approved for a maximum of 12 Credits.
Who will benefit:
• Trial Sponsors
• Principal Investigators
• Clinical Investigators
• Clinical Research Statisticians
• Clinical Research Coordinators
• Clinical Research Nurse Coordinators
• Clinical Research Associates/Assistants
• Clinical Project Managers/Leaders
• Study Managers
• Regulatory Professionals/Coordinators
• Medical Writers who need to interpret statistical reports
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:
• 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.
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:
• 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
• Clinical Research Associates/Assistants
• Clinical Project Managers/Leaders
• Study Managers
• Regulatory Professionals/Coordinators
• Medical Writers who need to interpret statistical reports
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:
• 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.
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:
• 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
KEY DATES
15 Nov, 2018
Event Start Date
16 Nov, 2018
Event End Date
SPECIALITIES
Research and Clinical ResearchSUGGESTED HOTELS
CONFERENCE VENUE
DoubleTree by Hilton Hotel Philadelphia AirportRELATED CONFERENCES & LIVE WEBINARS
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