Over 2 million people in the United States are estimated to become infected with drug-resistant bacteria each year, so new antibacterial therapies are desperately needed. Streamlined drug development approaches have the potential to accelerate the availability of new antibacterial drugs for patients with serious unmet need who have limited or no treatment options. CTTI has published findings on patient and physician attitudes regarding streamlined development approaches for antibacterial drugs in BMJ Open.
Through a series of interviews and focus group discussions, CTTI found that patients and physicians agreed on the usefulness of streamlined approaches in situations of unmet need, but both groups also emphasized the need for careful oversight, transparency in risk communication, and continuous monitoring and reporting of safety and efficacy post-approval.
These findings, which resulted from CTTI’s Unmet Need in Antibiotic Development Project, can help inform the future use of streamlined drug development approaches and communication with stakeholders. For example, patients described information they would like to know when treatment with a drug developed using a streamlined approach is being considered. They also expressed a preference to have early conversations with their providers around the potential use of these treatments before they become seriously ill, when their decision-making may be impaired.
CTTI gathered input on these findings and their impact in a multi-stakeholder expert meeting; a meeting summary is available for additional context. CTTI would like to thank the interview and focus group participants, expert meeting attendees, and project team members who contributed to this work.