Worldwide, 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 2 - Clinical Trials Phases II & III on April 13, 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 learning@scdm.org if you wish to attend the three webinars, and we will provide you with your discount code.