ONLINE WEBINAR · April 20, 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 Phase IV
Session Overview: This webinar will explore Phase IV post-marketing studies and will take you on a journey of continued drug development following regulatory approval. This last phase covers longer-term safety and efficacy of a treatment or device, providing additional information such as the treatment or drug risks, benefits and best use. Dealing with a much larger number of participants can pose challenges especially over a such a longer period of time.
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. Register for this webinar here.
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.
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 Trial Phases I on April 6, 2023
Webinar 2 - Clinical Trial Phases II & III on April 13, 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 email@example.com if you wish to attend the three webinars, and we will provide you with your discount code.
What You'll Learn
- Understand the Phase IV component in clinical trials
- Understand the study designs for Phase IV trials
- Understand the trail conduct for Phase IV trails and the goals of post-marketing
- Learn how the data of the Phase IV trials can be used to monitor long-term safety and efficacy, study cost, drug risks/benefits and best use.
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
Clinical Research Information, Hoosier Cancer Research NetworkAina Horton is a Manager of data Management at UBC located in Blue Bell, PA with over 16 years of pharmaceutical industry experience. Aina provides experience in trial start up to trial database lock; providing assistance and guidance across all functional clinical groups (e.g. Programming, Biostatistics, Clinical, Quality Assurance, etc.). Aina has experience leading multiple clinical trials in Phase I-IV across therapeutic areas. Aina is a mentor and leader who provides study oversight and guidance to team members to be successful in their roles.
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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