Adaptive Designs For Clinical Trials

Adaptive designs for clinical trials have

attracted a lot of attention recently because
they allow the trialist to start a study with less
information than is typically needed for a
successful trial. whatsoever you study online
need to often examined for the high quality and
precision. Not every little thing you can locate
on the internet may possibly be real. The web is
a wonderful source of data. It does not indicate
nonetheless that it is correct. It is in your very
best desire to double examine the validity of the
material.Typically, information about optimal
endpoints, effect size, optimal inclusion and
exclusion criteria, etc., are gathered from a
pilot or feasibility study and used to design the
pivotal trial.
Adaptive designs allow these two studies to be combined into a single trial saving the sponsor
company time and money and enhancing the chances for success with one or more looks at the data
to adjust the design as necessary. The adjustments can include the sample size, the hypotheses
tested, the endpoints evaluated, the patient subgroups included, etc. FDA has been receptive to
these designs as they come under pressure to increase the competitiveness of US companies by
decreasing time to market.
This webinar will help you identify situations in which adaptive designs would be advantageous and
describe the operational and administrative changes to trials under various adaptive designs.
Areas Covered in the Seminar:
* Definition of adaptive design.
* Benefits.
* Legal adaptations and when to use them.
* Regulatory acceptance.
* Details on how adaptations work.
* Examples.
* Q & A.

Learning objectives:
At the conclusion of this seminar, attendees will be able to:
* Identify situations in which adaptive designs would be advantageous
* List adaptive designs that apply under various situations
* Describe the operational and administrative changes to trials under various adaptive designs
Who Will Benefit:
Companies that develop regulated medical products, such as medical devices, pharmaceuticals, and
biologics.
* Clinical Research Professionals
* Clinical Research Organizations
* Regulatory Affairs
Instructor Profile:
Melissa Martinson, MS PhD, is a founder and President of Technomics Research, LLC. The company,
located in the Twin Cities, provides statistical and health economics evaluations of medical
technologies and services to the medical device, pharmaceutical, biologics, and managed-care
industries in support market approval by FDA and coverage by public and commercial healthcare
payers.
Dr. Martinson holds a B.A. in Biology from Swarthmore College, an M.S. in Statistics and a Ph.D. in
Health Services Research from the University of Minnesota. She is on the adjunct faculty at the
University of Minnesota and St. Cloud State University, where she teaches graduate-level statistics
and economic modeling.
Teresa Nelson, MS is a biostatistician with over 1510 years experience in the medical device
industry in the areas of statistics and health economics. She has extensive experience in study
design strategy - analysis of data, interpretation of results and writing of reports for government
regulatory bodies and commercial insurers. She has worked on projects in all phases of research
from feasibility or pre-market to those supporting market approval and and post-market and
outcomes studies. She has FDA panel experience and successfully negotiated many FDA IDE
approvals including some recent success with adaptive study designs.
Manya Harsch, MS is a biostatistician at Technomics Research, LLC with over 10 years of
experience in the medical device industry. She has worked at major medical device companies with
emphasis on cardiac and urological devices. She is an enthusiastic, experienced critical thinker with
strong statistical background and solid biological training and understanding of clinical trials. She
has extensive experience with pre-IDE, IDE and PMA submissions, Condition of Approval studies,
510K submissions, Japan PMDA submissions and supporting PMDA GCP audits.