ONLINE WEBINAR · April 13, 2023, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 21:30 IST
A journey through drug development in four phases - A CDM perspective: Clinical Trials Phases II & III
Session Overview: This webinar will explore Phase I/II, Phase II and Phase III clinical trials. FDA definitions of Phase II and Phase III trials will be the basis for the discussion. For each type of clinical trial, study design, trial conduct, critical data, and data review and analysis will be examined especially with respect of clinical data management. The standard 3+3 design will be investigated for the Phase I component of the Phase I/II clinical trial. The Phase II clinical trial will be examined with respect to the Simon Two Stage design. A standard randomized clinical trial design will used to illustrate Phase III "pivotal" clinical trials. Throughout the discussion implications for clinical data management will be emphasized.
About this Webinar SeriesWorldwide, drug development is based on clinical trials deployed in four phases. This webinar series will explore the different types of clinical trial design and data management approaches in all four phases.
While all phases of clinical research have safety as a primary objective, phase I clinical trials focus on initial safety and tolerability to determine an appropriate dose range for later phases. These studies are small and usually fast-paced. This first webinar will focus on the data management concepts specific to working in this environment. Register for this webinar here.
Phase II clinical trials look at safety and efficacy in smaller samples of subjects. These global multi-centered trials are usually shorter in duration and provide initial evidence of efficacy. Phase III trials are the “pivotal trials” to determine the effectiveness of an experimental treatment. These trials may involve thousands of volunteers and last four or more years. Phase III trials are usually the basis for regulatory approval. Both Phase II and III trials also have a primary focus on safety. The second webinar in the series will focus on the data management concepts specific to working in these stages of development.
The final webinar in the series will cover Phase IV post-marketing studies and will take you on a journey of continued drug development following regulatory approval. Dealing with a larger number of participants, these trials are conducted over a longer period of time (10+ years) and may also involve real world evidence and observational data to continue to monitor long-term safety and efficacy, study cost, drug risks/benefits and best use. Register for this webinar here.
Each webinar will focus on specific phases and delve into the data management topics important to each phase of development. After participating in this webinar series, you will understand the four phases of clinical trials. Examples of the most current experimental designs and data management approaches will be presented throughout the three sessions.
Webinar 1 - Clinical Trials Phase I on April 6, 2023
Webinar 3 - Clinical Trials Phase IV on April 20, 2023
You can attend one or several of the webinars in this series. Participants who wish to attend the entire series of three webinars will receive a 25% discount on the total price of the webinars. Please contact firstname.lastname@example.org if you wish to attend the three webinars, and we will provide you with your discount code.
What You'll Learn
- Understand the Phase I component in Phase I/II Clinical trials in oncology.
- Understand study designs for Phase II and Phase III trials.
- Understand trial conduct for Phase II and Phase III trials.
- Identify critical data for Phase II and Phase III trials and Understand Review and analysis of data.
Who Should AttendThe audience will be new clinical research professionals as well as those in managerial roles. Minimal clinical train research experience is required.
Meet the Speaker
Timothy E. Breen
Clinical Research Information, Hoosier Cancer Research NetworkTim has been with the Hoosier Cancer Research Netword (HCRN) since May, 2010. At HCRN, he was Director of Clinical Research Informatics, until he retired in 2019. Currently, he works part time for HCRN as a Clinical Research Informatician. Prior to the Hoosier Cancer Research Network, he was a Biostatistics Project Coordinator for the Indiana University Division of Biostatistics where he worked for thirteen years. For the past seventeen years, he has been involved in Oncology clinical trials both at the Division of Biostatistics and at HCRN. He has a Ph D. degree in Physiology and M.S. degree in Bioinformatics from Indiana University. Also, he is Co-Chair of the Education Committee of the Society of Clinical Data Management where he earned the Certified Clinical Data Manager (CCDM) designation.
Earn CEUsSCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
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