- March 2 - 3, 2020
- Mon, Mar 2
- Tue, Mar 3
2020 DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients
Co-Sponsored by the:
U.S. Food & Drug Administration (FDA)
Drug Information Association (DIA)
March 2-3, 2020
Tommy Douglas Conference Center
10000 New Hampshire Ave
Silver Spring, MD
The FDA and DIA have expressed a willingness to leverage their combined strengths for the joint development of this conference that will provide a platform for extensive scientific exchange among the FDA, other global health authorities including EMA, PMDA, and CFDA, patient advocates, and drug development innovators on CID topics such as master protocols, complex adaptive design, and Bayesian techniques, highlighting also the potential of alternative data sources.
Complex Innovative Trial Designs (CID) have the potential to increase the efficiency and lower the cost of drug development which will accelerate patient access to life-altering therapies. The 21st Century Cures Act (Cures Act) and the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) recognize the need for CID and include provisions to advance their use to enhance medical product development. One such provision within PDUFA VI is the launch and implementation of the FDA CID Pilot Meeting Program which aims to foster discussions and education of the use and value of CID within drug development programs. The DIA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients conference is designed to promote CID. Each session will begin with an introductory presentation by an FDA representative to set the stage followed by presentations and perspectives from a diverse group of expert speakers and panelists. The suitability of each CID topic and the proposed innovations from a US and global regulatory perspective, their usefulness from a patient perspective, and how challenges in the designs can be overcome, will be explored.
This program has been designed for key drug development decision makers including clinicians, regulatory scientists and reviewers, and other key stakeholders, in addition to statistical specialists.
Goals and Objectives
- Describe the hallmarks of the FDA Complex Innovative Trial Design (CID) Pilot Program, including examples of innovative designs in a regulatory environment and progress to date of the program.
- Examine principles and applications of adaptive and Bayesian trial designs in drug development, including regulatory perspectives on their use and exploration of successful examples.
- Discuss the perspectives of global health authorities on the application of complex innovative designs in medicines research and development within the regulatory context of regions outside the US.
- Provide a platform for scientific exchange and open discussion among FDA, global health authorities, drug development innovators, and patient representatives to explore how challenges in CID development and implementation can be overcome to advance the use of these designs in medical product development.
Who Should Attend?
The DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients Conference is intended for a diverse group of stakeholders responsible for and involved in the research, development, review, and regulatory approval of medical products such as drugs, biologics, and devices. This group includes interested industry, academic, patient, and government parties involved in ongoing efforts to address unmet medical needs of patients through the research and development of medical products. With affiliations in academic and government research organizations, biopharmaceutical and device companies, regulatory agencies and health authorities in the US and abroad, patient advocacy groups, non-profit organizations, and healthcare institutions, these stakeholders include scientists, clinicians, statisticians, regulatory scientists, patients and patient organization representatives, and leaders and decision-makers from all of these sectors.
If to DIA:
Barbara Lopez Kunz
Global Chief Executive
Drug Information Association (DIA)
21 Dupont Circle NW, Suite 300
Washington, DC 20036
If to FDA:
Dionne L. Price, Ph.D.
Director, Division of Biometrics IV
WO 21, Room 3508
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993