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[FDA News] FDA Announces Center for Clinical Trial Innovation (C3TI) to Streamline Drug Development

Date: 4/29/2024

The Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) recently announced a significant step towards accelerating the development of new drugs: The launch of the CDER Center for Clinical Trial Innovation (C3TI). This new center signifies the FDA's commitment to fostering creativity and collaboration in clinical trial design and execution.

Why is C3TI Important?

For years, CDER has championed innovative approaches to drug development. However, they recognized an opportunity to further enhance these efforts and maximize their impact. C3TI will act as a central hub, facilitating knowledge sharing within the FDA and fostering collaboration with external parties involved in clinical trials.

What will C3TI Do?

C3TI will focus on several key initiatives:

  • Knowledge Sharing:  C3TI will serve as a central resource within the FDA, promoting the exchange of best practices and lessons learned across various clinical trial innovation efforts.

  • External Collaboration:  The Center will actively collaborate with external stakeholders involved in clinical research. This will ensure effective communication and a collaborative environment to advance innovative trial designs.

  • Demonstration Program: C3TI will launch a program specifically designed to showcase innovative approaches in clinical trials. This program will focus on three key areas initially:

  • Point-of-care or pragmatic trials: These trials aim to evaluate the effectiveness of drugs in real-world settings.

  • Bayesian analyses: This is a statistical method that allows for the continuous updating of knowledge as new data becomes available.

  • Trials using selective safety data collection: This approach focuses on collecting safety data only on critical aspects, streamlining the trial process.

Benefits of C3TI

The establishment of C3TI holds promise for several key benefits:

  • Improved Efficiency: By promoting innovative trial designs, C3TI aims to streamline the drug development process, potentially leading to faster availability of new treatments.

  • Enhanced Effectiveness: Innovative approaches can lead to more robust clinical trials, providing stronger evidence of a drug's safety and efficacy.

  • Increased Diversity: C3TI's focus on innovative approaches may lead to the development of trials that are more accessible and appealing to a wider range of participants, fostering greater diversity in clinical research.

Overall, the launch of C3TI signifies the FDA's commitment to accelerating the development of safe and effective new drugs. By promoting innovative clinical trial designs and fostering collaboration, C3TI has the potential to make a significant impact on the future of drug development.

Want to Learn More?

Visit the C3TI webpage for more information and details on how to participate in the C3TI Demonstration Program.

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