Clinical Trial Design Considerations for Malaria Drug Development

The Food and Drug Administration (FDA) is announcing a public workshop regarding clinical trial design considerations for malaria drug development. FDA is interested in discussing the scientific challenges pertaining to malaria drug development and malaria parasite detection methods used as endpoints in clinical trials. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the design of clinical trials evaluating new drugs to treat malaria. The input from this public workshop will also help in developing topics for future discussion.

Date:

June 30, 2016

Time:

8:30 a.m. to 4:00 p.m.

Location:

The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993

For information regarding the FDA campus map, directions to FDA and security procedures, please visit the FDA website at: Public Meetings at the FDA White Oak Campus

Webcast Information:

Please note that this workshop will also be webcast live at: https://collaboration.fda.gov/malariadrugdevelopment/. The audio will be provided via the webcast through your computer speakers.

Workshop materials (agenda, slides and other information) will be posted prior to the workshop. Please check this webpage periodically before the workshop for information.

Webcasts:

Recording 1: https://collaboration.fda.gov/p55quyxda27/
Recording 2: https://collaboration.fda.gov/p3o7yj04gxh/
Recording 3: https://collaboration.fda.gov/p154ecvpgvt/
Recording 4: https://collaboration.fda.gov/p33ntp1pjqb/

 

Resources

• Malaria Workshop Agenda
• Malaria Workshop-Speakers and Panelists
• Malaria Panel Questions
• Dondorp, Background on Malaria and Combination Anti-Malarial Drug Therapy
• O'Shaughnessy, FDA Perspective: Scientific and Regulatory Issues Related to Anti-malarial Drug Combinations
• Kublin, Controlled Human Malaria Infection Trials (CHMI)
• McCarthy, Induced Blood Stage Malaria: a tool to facilitate development of antimalarials
• Mohrle, Pharmacology Considerations for Combination Malaria Treatment
• Felger, Molecular Detection – Quantification – Genotyping
• Suvarna, Regulatory Considerations When Detection Methods are Used in Clinical Trials
• Murphy, Recent Experience of Investigational Parasite Detection Methods in Controlled Human Malaria Infection Studies
• Saunders, Role of Malaria Detection Methods for Enrollment and Outcomes in Clinical Trials
• Transcript: Thursday, June 30, 2016