RACE Act is poised to significantly change clinical development. Are you ready?
Welcome to PRA’s source for all RACE Act-related information.
Our team is here to help you prepare for this historic transition in our industry. We’ll be updating this page bi-weekly with need-to-know RACE Act information, as well as relevant content supported by our oncology and pediatric experts.
What is the RACE Act?
The Research to Accelerate Cures and Equity (RACE) for Children Act becomes effective on August 18, 2020 and will impact all cancer drug development.
Under the RACE Act, new molecularly targeted compounds for adult cancers will need to be evaluated for children’s cancers if the molecular target or mechanism of action (MoA) of the drug, not the tumor type or indication, is relevant to the growth or progression of pediatric cancer.
Any new drug application (NDA) or biologics license application (BLA) submitted on or after August 18, 2020 for a new active ingredient must have an agreed initial pediatric study plan before submission.
Put simply, it will be standard practice for drug companies to develop their drugs for children with cancer. As a result, pediatric oncologists will have more precision medicine clinical trial options to offer young cancer patients and their families. These types of trials are expected to put more pediatric oncology drugs in the pipeline, ultimately offering improved therapeutic outcomes and decreased long-term side effects.
Read our team’s RACE Act insights.
In clinical research, half isn’t the whole story.
A child isn’t simply half an adult. Our industry is still guessing the clinical needs of children by settling for a fraction of what works in adults. That’s why we’re prepared to address your needs in the wake of RACE.
Our experts are ready to assist you with your pediatric plans prior to submission, encourage early sponsor communication with the FDA, and execute adult, pediatric, and combined studies. The CPCD created an inter-departmental team specifically focused on handling pediatric oncology trials. This team includes representatives from multiple facets of our company to ensure all-encompassing solutions explore innovative ways to incorporate pediatric patients into your oncology research.
We also have 30+ board-certified hematologists/oncologists and 8+ pediatric board-certified hematologists/oncologists.
The RACE Act is coming this August. Here’s what you need to know
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Collaboration is key.
Collaboration among industry partners is key to the successful implementation of RACE regulations. PRA has extensive experience with pediatric consortia. We establish mutually beneficial relationships in order to deliver pediatric clinical trials more effectively and efficiently. Our Pediatric Site Network (PSN), for example, is a select group of internationally recognized pediatric centers and medical professionals from around the globe that share the common goal of bringing treatment options and access to novel medicines to pediatric patients.
We can help you navigate the complexity of this new and exciting era of pediatric research and take oncology clinical trials to the next level.Learn more about the Center for Pediatric Clinical Development.
Now is the time to start a conversation.
The enactment of the RACE Act brings new questions and concerns. You may be wondering when you should speak with the FDA, how to get your pediatric study plan approved, and who you’ll contact to help you execute your study
Talk to our experts now to ensure you’ll be ready for RACE.Let’s work together to make sure you’re prepared for RACE.
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