quality and efficiency of clinical trials.
August 29, 2013
The Clinical Trials Transformation Initiative hosted an Antibacterial Drug Development Program Working Group Webinar on Aug 29, 2013 to provide an update on the program, and to make further progress on developing streamlined elements for a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). This webinar was a follow-up to a recently held workshop last April. The agenda for this collaborative effort included an update from the Foundation of the NIH (FNIH) HABP/VABP Working Group, followed by a lively discussion that focused on aspects of study design and endpoints. As with prior meetings, a variety of stakeholders attended the workshop, including academia, clinical experts, patient advocates, regulators, representatives from pharmaceutical companies, and others involved in the clinical research enterprise. The working group will incorporate the insight gained into the development of recommendations for elements for a Pilot Protocol for HABP/VABP studies.
"It is reassuring to see the progress made since the CTTI expert meeting held last October. A broader range of stakeholders has helped each person consider new possibilities in a much more open way, and should lead to a pilot protocol with better results that everyone can accept and act upon. I look forward to pushing the envelope further for all HABP/VABP patients, including a serious discussion of when superiority trials can be considered." Said Deborah Collyar, President, Patient Advocates In Research (PAIR) who attended the webinar.