ONLINE WEBINAR · April 6, 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 I
Session Overview: This webinar will explore Phase I clinical trials. 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.
OverviewWorldwide, 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.
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. 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 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 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 I component in clinical trials
- Understand the study designs for Phase I trials
- Understand the conduct of Phase I trials
- Understand how GCDMP is applied in Phase 1 trials
Who Should AttendThis webinar is dedicated to the beginner and intermediate level.
Meet the Speaker
Senior Director, Global Data Management and StandardsAdam Colley is a Senior Director with Merck & Co, Inc., Rahway, NJ, USA, where he has spent the past 23 years working in the Global Data Management & Standards group. During this time, Adam has held positions of increasing responsibility, both in a project and managerial capacity. After a number of years working as head over a number of therapeutic areas within the late stage project data management group, Adam is currently the head of the Early Development (EDEV) team, which provides data management services for all phase I healthy volunteer trials operated by the company.
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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