DDReg Pharma

DDReg Pharma

Center for Clinical Trial Innovation

Medical research is progressing rapidly to keep up with the increase in complex disease. This has highlighted the need for innovation in clinical trials that can be driven by enhanced communication and collaboration. Stakeholders such as clinicians, researchers, patients, etc. can accelerate the development of novel therapies in order to improve patient outcomes by enabling open dialogue and cooperation. Not only does this provide an avenue for efficiently exchanging ideas, expertise, and resources, but it also contributes towards a more efficient and smooth clinical trial process… leading to more advanced healthcare solutions.

CDER: Clinical Trial Innovation

Regulatory agencies like the US FDA have increasingly been making efforts to adopt innovation within clinical trials. The Center for Drug Evaluation and Research (CDER) has been a real trailblazer in guiding drug development and providing scientific and regulatory advice. But as more information on disease biology emerges, in line with more advances in drug discovery, an association with new treatment options also emerges. In this changing landscape, it’s important to embrace innovative clinical trial designs and strategies.

Significant milestones have been achieved in clinical trial design and conduct through CDER’s continuing efforts. However, there is always scope for further innovation. In October 2023, solicited public comments from CDER were made on the obstacles and enablers to adopting innovative approaches to clinical trials.

In its bid to improve clinical trials, the Food and Drug Administration (FDA) has made a significant move by unveiling the Center for Clinical Trial Innovation (C3TI) under the Center for Drug Evaluation and Research (CDER). C3TI was announced on April 15, 2024, with an aim of becoming a hub. The center embraces inventive strategies in clinical trials. This Project is aimed at enhancing drug development quality and efficiency too. Additionally, it will assist regulatory decisions concerning such drugs.

C3TI seeks to enhance the innovation of clinical trials by enhancing communication and collaboration. It will do this through amalgamation of lessons from diverse CDER programs and facilitating knowledge sharing within FDA and with external stakeholders. The main aim of C3TI is to create an environment that encourages the development of innovative clinical trial designs and approaches. This will in turn help fast track the process of developing new drugs that are safe as well as effective.

Goals of C3TI

According to the CDER C3TI note, C3TI aims to achieve several key objectives. These include assisting stakeholders in staying current with the latest in clinical trial innovations. Enhancing efficiency and effectiveness, promotes greater inclusion of diverse populations in clinical trials. Improve quality of clinical trial data and accelerate development of safe and effective new drugs. Additionally, C3TI will serve as hub for coordinating and managing lessons learned across CDER’s programs. Establish a demonstration program featuring case examples to spur innovation across therapeutic areas. 

Activities of C3TI

C3TI is a centralized hub where stakeholders can connect with CDER regarding new approaches to clinical trials. It will have a website, fda.gov/C3TI, where all information about CDER’s efforts and resources for clinical trial innovation will be available.

The following constitute the main activities of C3TI:

  • Engaging with stakeholders and providing support for general inquiries about innovative clinical trial approaches.
  • Acting as a bridge to facilitate the exchange of information with external stakeholders, within the boundaries of the law.
  • Promoting knowledge sharing within CDER through various channels such as forums, communications, and a centralized knowledge repository.

C3TI Demonstration Program

A critical component of C3TI is the C3TI Demonstration Program, which aims to enhance communication between CDER and sponsors of innovative clinical trials. This program will include case examples from ongoing development programs in specific project areas. These examples will serve as models to foster further innovation across therapeutic areas.

The initial project areas under the C3TI Demonstration Program include:

  1. Point-of-Care or Pragmatic Trials: Trials conducted in routine clinical practice settings.
  2. Bayesian Analyses: Advanced statistical approaches for trial analysis.
  3. Selective Safety Data Collection: Focused collection of safety data to streamline trial processes.


The establishment of C3TI is a crucial step forward for clinical trial innovation. By encouraging collaboration and creativity, C3TI has the potential of improving clinical trial’s quality, speed as well as accessibility. This further leads to an increase in the pace at which new treatments are developed. Thus, for patients there will be better results leading to improvements in public health status. For more information, please visit FDA’s official website ‘fda.gov/C3TI’.

In addition to regulatory and pharmacovigilance services for global customers, DDReg Pharma also offers expert clinical regulatory services  to support with the Clinical Trial Applications. Reach out to the experts for more information. Read more from the experts about clinical trials here: Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products