During the 2009 H1N1 pandemic, the National Institutes of Health turned to Rho to rapidly develop and coordinate a national, multi-site research project to evaluate the effectiveness and dosing of the H1N1 vaccine for those with asthma. In collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), the National Heart Lung and Blood Institute (NHLBI), and the NHLBI’s Severe Asthma Research Program (SARP), our investigators and project coordinators developed and implemented a new multi-center research protocol to address these urgent issues.

Successes from this research effort include:

• In less than 18 months, the Rho team went from initial study idea to publication of primary study results.
• Within 2 months of it being declared a pandemic, the first version of the protocol was completed and 7 clinical centers agreed to participate.
• Over the course of 2½ weeks, Rho and NIH staff conducted SIVs and protocol training for all sites.
• 3 months after the first study visit, the sites had enrolled all 390 participants and completed all dosing.

We were able to accomplish these timelines by having a small, nimble project team, a dedicated network of sites, and very close collaboration with the sponsor.

In addition to providing important information for healthcare policymakers, this multi-center study represented an extremely successful research collaboration to design, implement, and publish study results against the backdrop of a global pandemic.

Read the case study.