Safety
CTTI Publishes Findings on Patient & Physician Perceptions of Streamlined Development for Antibacterial Drugs
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.
Parent & Provider Input on Opportunities to Improve Antibacterial Clinical Trials: Findings Presented at Cystic Fibrosis
On October 27, CTTI presented findings from its Pediatric Trials in Antibacterial Drug Development Project at the North American Cystic Fibrosis Conference. Conducting antibacterial trials in pediatric populations has unique challenges, yet safe and effective therapies are desperately needed for this vulnerable group. We conducted surveys and interviews with pediatric providers, investigators, and parents to determine barriers to conducting these trials and obtain suggestions for strategies to overcome them.
View the poster to learn more about our findings:
- Perceived barriers to conducting pediatric antibacterial drug trials
- The need for better engagement with parents
- Approaches for making studies child- and parent-friendly
- Strategies for improving communication and enrollment
These findings, along with multi-stakeholder input, are being used to generate recommendations to improve the quality and efficiency of pediatric antibacterial drug trials.
Improving Pediatric Trials in Antibacterial Drug Development: Expert Meeting Materials Now Available
On April 5, 2016, CTTI’s Pediatric Antibiotic Trials Project hosted a multi-stakeholder expert meeting to develop consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs. Findings from the project’s surveys and interviews were presented, and stakeholders from across the clinical trial enterprise provided input on draft considerations for improving pediatric antibacterial drug trials.
Areas of focus at the expert meeting included challenges in designing and conducting pediatric trials (including neonatal studies), pediatric labeling, and informed consent. Potential strategies discussed to address these challenges included developing pan-global networks to conduct pediatric trials using master protocols, achieving alignment between global regulatory agencies, improving awareness of opportunities for industry to communicate with the FDA when designing Pediatric Study Plans, and improving communication in the consent process.
We now invite you to view the materials from this meeting. The multi-stakeholder feedback from the meeting, along with evidence gathered through the CTTI project, is being used to inform the development of recommendations to help achieve higher quality, more efficient pediatric trials for antibacterial drugs. CTTI’s official recommendations are expected to be released in 2017.
CLICK HERE to access the meeting summary, slides, agenda, and other materials
This project is part of CTTI’s Antibacterial Drug Development Program.
Unmet Need in Antibiotic Development: Expert Meeting Materials Now Available
On March 1, 2016, CTTI hosted a multi-stakeholder expert meeting for its Unmet Need in Antibiotic Development Project. This project is investigating perceptions of antibacterial drugs developed using accelerated pathways. Non-traditional development pathways can expedite the availability of much-needed new antibacterial therapies, but there is a tradeoff in risk and uncertainty.
At the expert meeting, results were presented from focus groups and interviews conducted to elicit opinions from patients, healthy persons, caregivers, and physicians on the use of antibacterial drugs developed using streamlined approaches. Meeting attendees, which included representatives from academia and pharmaceutical companies, patient advocates, regulators, and other stakeholders, discussed ways to improve labeling, risk communication, and public understanding in the context of streamlined antibacterial drug development approaches. This input informed interpretation of the findings and project next steps. We are now pleased to share the meeting materials, which may inform others working to address the serious public health issue of antibacterial resistance.
CLICK HERE to access the meeting summary, slides, agenda, and other materials.
This project is part of CTTI’s Antibacterial Drug Development Program.
New NIH Policy Aligns With CTTI’s Work to Increase Adoption of Central IRBs
The NIH has issued a final policy requiring the use of a single institutional review board (IRB) for multi-center NIH-funded clinical trials. The policy will take effect May 25, 2017.
Since 2010, CTTI has been working to address barriers to the adoption of central IRBs for multi-center clinical trials through its Central IRB and subsequent Central IRB Advancement projects. The draft NIH policy released in 2014 referenced CTTI’s recommendations, and the final policy reflects CTTI’s shared goal to increase the efficiency of clinical trials through the use of central IRBs.
With the NIH mandate now finalized, CTTI’s tools are available to help with implementation. These include the following:
- a template IRB authorization agreement
- an evaluation checklist with considerations for 1) assessing an institution’s readiness for central IRB adoption, 2) selecting a central IRB, and 3) deciding when a central IRB should work with a specific institution
- a considerations document to address the often blurred distinctions between responsibilities for ethics review and other institutional obligations
According to the new policy, “while the NIH anticipates that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of [single IRBs] will outweigh any costs and, ultimately, reduce burdens to the research process.”
CTTI applauds this important progress for the clinical trials enterprise.
Recording Now Available: Webinar on IND Safety Reporting
Are you confused about how best to comply with the FDA final rule on IND safety reporting? Would you like to hear more about how to handle common, yet challenging, safety reporting situations?
We invite you to view the recording from CTTI’s webinar, which explored challenging safety reporting scenarios using case studies. Presenters from CTTI’s IND Safety Advancement Project Team included representatives from CTTI, FDA, and industry.
To view recommendations and publications from CTTI’s IND Safety Advancement Project, CLICK HERE.