DMCs are changing rapidly, along with the current clinical trial changes seen in recent years, accelerated further since the onset of COVID-19.
TORONTO (PRWEB)
May 05, 2021
Implementing data monitoring committees (DMCs) for the rapidly changing clinical trials in the last decade and during the COVID-19 pandemic, and planning for them in future clinical trials presents unique challenges. PRA has developed strategies to address these challenges, and will present these latest developments in this upcoming webinar.
DMCs are changing rapidly, along with the current clinical trial changes seen in recent years, accelerated further since the onset of COVID-19. These changes can be seen from DMC data delivery to DMC data analysis, DMC planning and setup and ultimately DMC management.
In recent years, research on novel clinical trial and clinical development plan designs to address unmet medical needs in rare diseases, personalized medicine, virtual trials and incorporation of Real World Evidence has accelerated greatly, leading to a myriad of novel adaptive, Bayesian and innovative statistical designs.
Due to the changes in trial designs and regulatory demands, old standard processes to run a DMC are also changing. The new paradigms, including adaptive designs and virtual trials, have impacted the objectives and demands of DMC processing. These novel trial designs have a more complex data flow with unique challenges in analysis and delivery.
As a result of these developments, an urgent need has arisen to train clinical trial professionals to support DMCs using both standard paradigms AND paradigms appropriate for the rapidly changing designs that are arising.
Join experts from PRA Health Sciences, in a live webinar on Tuesday, May 25, 2021 at 1pm EDT
- John Constant, PhD, Vice President, Scientific Affairs, Statistical Consulting
- Karen Shaffer, RN, MHA, Associate Director of Operations, DMC Unit
- Lance Dado, DMC Project Manager
For more information, or to register for this event, visit Data Monitoring Committees in the Changing Landscape of Clinical Trials.
ABOUT PRA HEALTH SCIENCES
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit http://www.prahs.com.
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